An interventional study of ES-130 in Fecal Incontinence and Bowel Incontinence, sponsored by NICHD Pelvic Floor Disorders Network. Completed at 9 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by NICHD Pelvic Floor Disorders Network · Not applicable, Interventional, and Treatment
Among 101 studies in Fecal Incontinence with a site in United States — 14 open to participants now, 19 under way, 2 of them phase 3. Fecal Incontinence · United States.
Among the 101 studies in Fecal Incontinence with a site in United States, this one is the 15th largest by enrollment of the 79 interventional ones that give a count, is one of 6 that started in 2018, is one of 58 with no phase, and was the 58th registered.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's enrollment of 166 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →14 of the 101 studies in Fecal Incontinence with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →101 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 6 started in 2018.
Median enrollment 44 across the 79 interventional studies, 80 across the 21 observational. Of the 70 that completed or were terminated, 35 (50%) have results posted.
27 of 101 have an industry lead sponsor. The 10 most frequent:
NICHD Pelvic Floor Disorders Network is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
NICHD Pelvic Floor Disorders Network has 3 studies filed under Fecal Incontinence — fewer than ten, so there is no comparison to draw.
11 of the studies in Fecal Incontinence with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05776277Phase 3Cook MyoSiteIltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury | 2026-12 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
Among the 101 studies in Fecal Incontinence with a site in United States, from their registry updates:
This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women.
The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
The overarching goal of this randomized clinical trial is to determine if PTNS is more effective than sham PTNS for the treatment of FI in women after 12 weeks of treatment and 1 year after initiating treatment. This is a two-part trial with a Run-In Phase prior to randomization. The trial has the following primary aim:
To determine whether the change from baseline in St. Mark's (Vaizey) score in women with symptomatic ABL undergoing PTNS differs from sham after 12 weeks of stimulation.
Additional secondary aims include:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator.
Device: ES-130
Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation.
Device: ES-130
The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline St. Mark's (Vaizey) Score
The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week \[4, 8, or 12\] Score minus the score at baseline.
Time frame: 4, 8, and 12 Weeks
Responder to Treatment
Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score
Time frame: 4, 8, and 12 Weeks
Change From Baseline Number of Fecal Incontinence Events Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline Number of Urge Fecal Incontinence Events Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline Number of Bowel Movements Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline Number of Urge Bowel Movements Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
50% Improvement in Fecal Incontinence Episodes Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline
Time frame: 8 and 12 Weeks
75% Improvement in Fecal Incontinence Episodes Per Week
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.
Time frame: 8 and 12 Weeks
Patient Global Impression-Improvement
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)
Time frame: 4, 8, and 12 Weeks
Change From Baseline ABLe Liquid Score
The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Solid Score
The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Mucus Score
The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Gas Score
The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Predictability/Awareness Score
The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Control Score
The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Ancillary Bowel Symptoms Score
The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.
Time frame: 8 and 12 Weeks
Change From Baseline ABLe Overall Score
The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.
Time frame: 8 and 12 Weeks
Patient Global Symptom Control
The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)
Time frame: Baseline and 4, 8, and 12 Weeks
Change From Baseline FIQL Lifestyle Score
The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline FIQL Coping Score
The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline FIQL Depression Score
The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline FIQL Embarrassment Score
The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline FISI Patient Score
The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline FISI Doctor Score
The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Incontinence Impact Score
The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Role Limitations Score
The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Physical Limitations Score
The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Social Limitations Score
The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Personal Relationship Score
The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Emotional Function Score
The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Sleep/Energy Score
The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline MMHQ Severity Measures Score
The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
Time frame: 8 and 12 Weeks
Change From Baseline CRAIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Change From Baseline POPIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Change From Baseline UIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Change From Baseline PFIQ Score
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 8 and 12 Weeks
Change From Baseline PAC-SYM Abdominal Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Change From Baseline PAC-SYM Rectal Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Change From Baseline PAC-SYM Stool Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Change From Baseline PAC-SYM Total Score
The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
Time frame: 12 Weeks
Change From Baseline PISQ-IR NSA-PR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR NSA-CS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR NSA-GQA Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR NSA-CI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-AO Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-PR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-CS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-GQR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-CI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-D Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline PISQ-IR SA-AVG Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline FIAI Hygiene Index Score
The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline FIAI Avoidance Index Score
The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline SF-12 Aggregate Physical Score
The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
Time frame: 12 Weeks
Change From Baseline SF-12 Aggregate Mental Score
The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline
Time frame: 12 Weeks
| Milestone | Percutaneous Tibial Nerve Stimulation (PTNS) | Validated Sham |
|---|---|---|
| Started | 111 | 55 |
| Completed | 108 | 54 |
| Not completed | 3 | 1 |
| Withdrew: Lost to follow-up | 3 | 1 |
The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week \[4, 8, or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 4 | -2.8 (-3.5 to -2) | -3.3 (-4.5 to -2.1) |
| Week 8 | -4.3 (-5.2 to -3.3) | -4.1 (-5.4 to -2.9) |
| Week 12 | -5.3 (-6.3 to -4.3) | -3.9 (-5.3 to -2.6) |
Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score
| Participants | PTNS | Sham |
|---|---|---|
| Week 4 — Responder | 39 | 24 |
| Week 4 — Non-responder | 63 | 26 |
| Week 8 — Responder | 54 | 29 |
| Week 8 — Non-responder | 51 | 23 |
| Week 12 — Responder | 64 | 26 |
| Week 12 — Non-responder | 40 | 28 |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.
| episodes per week | PTNS | Sham |
|---|---|---|
| Week 8 | -2.4 (-3.1 to -1.6) | -1.6 (-3.2 to 0) |
| Week 12 | -2.3 (-3.2 to -1.5) | -2.1 (-3.7 to -0.4) |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.
| episodes per week | PTNS | Sham |
|---|---|---|
| Week 8 | -1.3 (-1.8 to -0.8) | -0.4 (-1.1 to 0.2) |
| Week 12 | -1.1 (-1.6 to -0.6) | -0.8 (-1.4 to -0.1) |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.
| episodes per week | PTNS | Sham |
|---|---|---|
| Week 8 | -1.8 (-3 to -0.6) | -0.2 (-1.6 to 1.1) |
| Week 12 | -1.8 (-2.8 to -0.9) | -1.5 (-2.8 to -0.2) |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.
| episodes per week | PTNS | Sham |
|---|---|---|
| Week 8 | -1.9 (-2.9 to -0.8) | -1.1 (-2.2 to -0.1) |
| Week 12 | -2.3 (-3.2 to -1.3) | -2.2 (-3.3 to -1.1) |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.
| episodes per week | PTNS | Sham |
|---|---|---|
| Week 8 | 1 (0.6 to 1.4) | 0.8 (0.3 to 1.3) |
| Week 12 | 1.3 (0.9 to 1.7) | 0.8 (0.2 to 1.4) |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline
| Participants | PTNS | Sham |
|---|---|---|
| Week 8 — >= 50% Improvement | 38 | 14 |
| Week 8 — < 50% Improvement | 61 | 35 |
| Week 12 — >= 50% Improvement | 51 | 19 |
| Week 12 — < 50% Improvement | 46 | 29 |
Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.
| Participants | PTNS | Sham |
|---|---|---|
| Week 8 — >= 75% Improvement | 19 | 10 |
| Week 8 — < 75% Improvement | 80 | 39 |
| Week 12 — >= 75% Improvement | 32 | 13 |
| Week 12 — < 75% Improvement | 65 | 35 |
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)
| Participants | PTNS | Sham |
|---|---|---|
| Week 4 — Improved | 20 | 13 |
| Week 4 — No improvement | 83 | 37 |
| Week 8 — Improved | 36 | 17 |
| Week 8 — No improvement | 70 | 33 |
| Week 12 — Improved | 47 | 21 |
| Week 12 — No improvement | 56 | 33 |
The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.3 (-0.4 to -0.1) | -0.5 (-0.8 to -0.2) |
| Week 12 | -0.6 (-0.8 to -0.4) | -0.7 (-1 to -0.4) |
The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.5 (-0.7 to -0.3) | -0.4 (-0.6 to -0.1) |
| Week 12 | -0.7 (-0.9 to -0.5) | -0.7 (-1 to -0.4) |
The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.5 (-0.7 to -0.3) | -0.4 (-0.7 to -0.1) |
| Week 12 | -0.7 (-0.9 to -0.5) | -0.4 (-0.7 to -0.1) |
The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.3 (-0.5 to -0.1) | -0.2 (-0.5 to 0.1) |
| Week 12 | -0.4 (-0.6 to -0.3) | -0.4 (-0.7 to -0.1) |
The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | 0 (-0.2 to 0.1) | 0 (-0.2 to 0.2) |
| Week 12 | -0.2 (-0.4 to -0.1) | 0 (-0.2 to 0.2) |
The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.3 (-0.5 to -0.2) | -0.3 (-0.6 to -0.1) |
| Week 12 | -0.6 (-0.8 to -0.4) | -0.6 (-0.9 to -0.3) |
The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.4 (-0.5 to -0.2) | -0.3 (-0.6 to -0.1) |
| Week 12 | -0.7 (-0.9 to -0.5) | -0.4 (-0.6 to -0.1) |
The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -0.4 (-0.5 to -0.2) | -0.3 (-0.6 to -0.1) |
| Week 12 | -0.7 (-0.9 to -0.5) | -0.4 (-0.6 to -0.1) |
The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)
| Participants | PTNS | Sham |
|---|---|---|
| Baseline — No Control | 18 | 10 |
| Baseline — Control | 93 | 44 |
| Week 4 — No Control | 46 | 25 |
| Week 4 — Control | 59 | 25 |
| Week 8 — No Control | 70 | 33 |
| Week 8 — Control | 36 | 19 |
| Week 12 — No Control | 82 | 40 |
| Week 12 — Control | 22 | 14 |
The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | 0.3 (0.2 to 0.5) | 0.4 (0.2 to 0.6) |
| Week 12 | 0.6 (0.5 to 0.8) | 0.4 (0.2 to 0.6) |
The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | 0.4 (0.3 to 0.5) | 0.4 (0.2 to 0.6) |
| Week 12 | 0.6 (0.5 to 0.8) | 0.5 (0.3 to 0.7) |
The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | 0.3 (0.2 to 0.4) | 0.2 (0 to 0.4) |
| Week 12 | 0.5 (0.4 to 0.6) | 0.2 (0.1 to 0.4) |
The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | 0.4 (0.3 to 0.5) | 0.4 (0.2 to 0.6) |
| Week 12 | 0.7 (0.6 to 0.9) | 0.4 (0.3 to 0.6) |
The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -4.9 (-7.1 to -2.8) | -5.9 (-8.7 to -3.1) |
| Week 12 | -7.5 (-9.7 to -5.3) | -6.7 (-10.1 to -3.3) |
The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -5 (-7.3 to -2.8) | -6.3 (-9.2 to -3.4) |
| Week 12 | -7.4 (-9.8 to -5) | -7 (-10.5 to -3.5) |
The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -9.4 (-14.5 to -4.2) | -11.3 (-17.9 to -4.6) |
| Week 12 | -17.2 (-23 to -11.5) | -15.9 (-23.4 to -8.3) |
The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -9.8 (-14.6 to -5.1) | -3.1 (-10.4 to 4.3) |
| Week 12 | -17.5 (-22.6 to -12.3) | -9.9 (-17.1 to -2.6) |
The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -10.3 (-15.3 to -5.3) | -3.8 (-9.2 to 1.6) |
| Week 12 | -20.4 (-25.5 to -15.2) | -10.6 (-16.6 to -4.5) |
The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -9.6 (-15.3 to -3.9) | -1.8 (-7.5 to 3.9) |
| Week 12 | -14.8 (-20.1 to -9.5) | -8.6 (-14.6 to -2.7) |
The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -5 (-11.6 to 1.6) | -2.2 (-11.5 to 7) |
| Week 12 | -6.2 (-11.3 to -1) | -11.4 (-23.2 to 0.4) |
The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -7.2 (-11.7 to -2.7) | -4.6 (-10.6 to 1.5) |
| Week 12 | -14.4 (-19.1 to -9.6) | -7.4 (-14.3 to -0.4) |
The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -7.2 (-11.4 to -3) | -4.3 (-10.8 to 2.3) |
| Week 12 | -11 (-15.2 to -6.8) | -6.4 (-12.4 to -0.3) |
The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -9.1 (-13.2 to -5) | -10.7 (-15.9 to -5.6) |
| Week 12 | -17 (-21.3 to -12.6) | -11.8 (-17 to -6.6) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -12.9 (-17.1 to -8.7) | -12.8 (-19.6 to -5.9) |
| Week 12 | -19.1 (-24.2 to -14) | -14.5 (-22.2 to -6.9) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -3.3 (-7.2 to 0.7) | -5.1 (-8.8 to -1.5) |
| Week 12 | -5.2 (-8.1 to -2.3) | -5.6 (-9.8 to -1.4) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -3.3 (-6.4 to -0.1) | -10.2 (-15.3 to -5) |
| Week 12 | -7.2 (-10.6 to -3.8) | -10.5 (-16.5 to -4.6) |
The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
| units on a scale | PTNS | Sham |
|---|---|---|
| Week 8 | -19.4 (-27.7 to -11.1) | -28.1 (-39.9 to -16.2) |
| Week 12 | -31.5 (-40.3 to -22.7) | -30.7 (-43.7 to -17.6) |
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PAC-SYM Abdominal Score | -0.4 (-0.6 to -0.3) | -0.2 (-0.4 to 0) |
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PAC-SYM Rectal Score | -0.1 (-0.3 to 0.0) | -0.1 (-0.3 to 0.1) |
The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PAC-SYM Stool Score | -0.3 (-0.5 to -0.1) | -0.2 (-0.5 to 0.0) |
The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PAC-SYM Total Score | -0.3 (-0.4 to -0.2) | -0.2 (-0.4 to 0.0) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR NSA-PR Score | 0.1 (-0.3 to 0.4) | -0.1 (-0.4 to 0.1) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR NSA-CS Score | 0.2 (-0.1 to 0.5) | 0.2 (-0.2 to 0.6) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR NSA-GQA Score | 0.4 (0.1 to 0.6) | 0.3 (0 to 0.5) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR NSA-CI Score | 0.4 (0.1 to 0.7) | 0.3 (0.0 to 0.6) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-AO Score | 0.2 (0.1 to 0.4) | 0.2 (0.0 to 0.4) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-PR Score | 0.1 (0.0 to 0.3) | 0.0 (-0.2 to 0.2) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-CS Score | 0.3 (0.1 to 0.6) | 0.5 (0.2 to 0.8) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-GQR Score | 0.3 (0.1 to 0.6) | 0.4 (-0.1 to 0.9) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-CI Score | 0.4 (0.2 to 0.6) | 0.3 (0.0 to 0.6) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-D Score | 0.0 (-0.1 to 0.2) | 0.2 (-0.2 to 0.6) |
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline PISQ-IR SA-AVG Score | 0.2 (0.1 to 0.4) | 0.3 (0.1 to 0.5) |
The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline FIAI Hygiene Index Score | -10.2 (-14 to -6.5) | -2.8 (-8.4 to 2.9) |
The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline FIAI Avoidance Index Score | -12.8 (-16.1 to -9.4) | -6.4 (-12.2 to -0.6) |
The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline SF-12 Aggregate Physical Score | 2.6 (1.1 to 4.2) | 2.1 (-1 to 5.3) |
The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline
| units on a scale | PTNS | Sham |
|---|---|---|
| Change From Baseline SF-12 Aggregate Mental Score | 0.9 (-1.3 to 3.1) | -0.7 (-4.2 to 2.9) |
Collected over 12 Weeks. Non-serious events are listed at a 0.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PTNS | 1/111 (0.9%) | 4/111 (3.6%) | 72/111 (64.9%) |
| Sham | 0/55 (0%) | 2/55 (3.6%) | 30/55 (54.5%) |
| Event | PTNS | Sham |
|---|---|---|
| ColitisGastrointestinal disorders | 0/111 | 1/55 |
| Localised infectionInfections and infestations | 0/111 | 1/55 |
| Myocardial infarctionCardiac disorders | 1/111 | 0/55 |
| Hiatus herniaGastrointestinal disorders | 1/111 | 0/55 |
| DeathGeneral disorders | 1/111 | 0/55 |
| Femur fractureInjury, poisoning and procedural complications | 1/111 | 0/55 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/111 | 0/55 |
| Event | PTNS | Sham |
|---|---|---|
| Urinary tract infectionInfections and infestations | 14/111 | 4/55 |
| ParaesthesiaNervous system disorders | 11/111 | 2/55 |
| Medical device site haemorrhageGeneral disorders | 9/111 | 0/55 |
| NasopharyngitisInfections and infestations | 7/111 | 2/55 |
| DiarrhoeaGastrointestinal disorders | 6/111 | 1/55 |
| FallInjury, poisoning and procedural complications | 6/111 | 1/55 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 5/111 | 0/55 |
| Abdominal pain upperGastrointestinal disorders | 1/111 | 2/55 |
| ConstipationGastrointestinal disorders | 4/111 | 2/55 |
| Upper respiratory tract infectionInfections and infestations | 1/111 | 2/55 |
| Age, Continuous(years) | PTNS | Sham | Total |
|---|---|---|---|
| Mean | 63.5 ± 12 | 63.8 ± 11 | 63.6 ± 12 |
| Sex/Gender, Customized(Participants) | PTNS | Sham | Total |
|---|---|---|---|
| Female | 111 | 55 | 166 |
| Ethnicity (NIH/OMB)(Participants) | PTNS | Sham | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 6 | 16 |
| Not Hispanic or Latino | 99 | 49 | 148 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | PTNS | Sham | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 10 | 9 | 19 |
| White | 95 | 39 | 134 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Body Mass Index(kg/m^2) | PTNS | Sham | Total |
|---|---|---|---|
| Mean | 29.2 ± 7 | 29.7 ± 6 | 29.4 ± 7 |
| Current Smoker(Participants) | PTNS | Sham | Total |
|---|---|---|---|
| Yes | 9 | 5 | 14 |
| No | 102 | 50 | 152 |
| Ever Pregnant(Participants) | PTNS | Sham | Total |
|---|---|---|---|
| Yes | 107 | 50 | 157 |
| No | 4 | 5 | 9 |
| Number of Vaginal Deliveries(deliveries per participant) | PTNS | Sham | Total |
|---|---|---|---|
| Median | 2 (0 to 9) | 2 (0 to 7) | 2 (0 to 9) |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Mar 2020, 25 months.
Results were first posted in May 2021, 1 year 2 months after primary completion.
Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's 25 months is below that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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NICHD Pelvic Floor Disorders Network