An observational study in Urinary Retention, Urinary Urge Incontinence and Urgency-Frequency, sponsored by Axonics, Inc.. Completed at 27 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Axonics, Inc. (part of Boston Scientific Corporation) · Observational
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
The study will be a prospective, multi-center, single-arm, post-market registry study. Participant outcomes will be compared to their baseline, with participants serving as their own control.
The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 272 is above the median of 116 across 45 observational studies indexed under Urinary Retention.
Browse Urinary Retention studies →Axonics, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
First submitted before Axonics, Inc. became part of Boston Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Participants who are scheduled to undergo an Axonics Trial or Axonics System will be considered candidates for the study and will be recruited from each Investigator's patient population.
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:
For all indications:
A female with a positive urine pregnancy test
For OAB \& UR:
Current symptomatic urinary tract infection (UTI)
For FI only:
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.
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.
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.
Therapy Responder Rate
Percentage of participants who were determined as responders by the treating physician when using the External Trial Stimulator and who received the Axonics System. At least a 50% reduction in symptoms is considered standard in relevant literature for response rate therefore decision for determination of responder was left to PI discretion.
Time frame: External Trial System Evaluation
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the degree of urgency leaks experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the degree of urgency experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the degree of urgency experienced.
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Change in ICIQ-OABqol scores at follow-up compared to baseline for implanted participants. Questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is considered a minimally important difference (MID).
Time frame: 6-months, 1-year
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UR diagnosis at baseline were asked about the number of catheterizations required per day.
Time frame: 6-months, 1-year
Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.
Time frame: 6-months, 1-year
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
Change in FIQL score compared to baseline for implanted participants. Fecal Incontinence Quality of Life (FIQL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
Time frame: 6-months, 1-year
Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
Change in O'Leary Sant score at follow-up compared to baseline for all implanted participants. The O'Leary Sant is a validated questionnaire designed to provide data on painful bladder and urinary frequency symptoms. Symptom and Problem Index scores are calculated based on responses to two sets of 4 questions with higher scores representing more symptoms/problems. A total score from 0 - 40 is also calculated based on all responses. At follow-up, an O'Leary Sant was only collected for those participants an O'Leary Sant score ≥ 6 at baseline.
Time frame: 6-months, 1-year
Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
Change in AUA-SI score at follow-up compared to baseline for Urinary Retention participants who were implanted with the device. The AUA-SI (American Urological Association Symptom Index) is a questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) in men, with scores ranging from 0 to 35, categorizing symptoms as mild (0-7), moderate (8-19), or severe (20-35). A higher score indicates more severe UR symptoms and a score of greater than 8 indicates moderate to severe UR symptoms.
Time frame: 6-months, 1-year
Adverse Event Reporting (Safety)
The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).
Time frame: 1-year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the Participant Flow are not able to be stratified into each type of diagnosis.
| Milestone | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Started | 272 |
| Completed | 268 |
| Not completed | 4 |
| Milestone | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Started | 268 |
| Completed | 253 |
| Not completed | 15 |
| Milestone | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Started | 253 |
| Completed | 250 |
| Not completed | 3 |
| Milestone | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Started | 250 |
| Completed | 218 |
| Not completed | 32 |
Percentage of participants who were determined as responders by the treating physician when using the External Trial Stimulator and who received the Axonics System. At least a 50% reduction in symptoms is considered standard in relevant literature for response rate therefore decision for determination of responder was left to PI discretion.
| Participants | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Therapy Responder Rate | 206 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.
| leaks per day | Overactive Bladder (OAB) - Urinary Urge Incontinence (UUI) |
|---|---|
| Baseline: Urgency leaks per day | 4.8 ± 6.1 |
| 6-month: Urgency leaks per day | 2.4 ± 2.7 |
| 1-year: Urgency leaks per day | 2.4 ± 3.6 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.
| leaks after bed | Overactive Bladder (OAB) - Urinary Urge Incontinence (UUI) |
|---|---|
| Baseline: Urgency leaks after bed | 2.2 ± 2.8 |
| 6-month: Urgency leaks after bed | 1.1 ± 2.0 |
| 1-year: Urgency leaks after bed | 1.0 ± 2.0 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.
| urinations per day | Overactive Bladder (OAB) - Urinary Frequency (UF) |
|---|---|
| Baseline: Urinations per day | 8.8 ± 4.5 |
| 6-month: Urinations per day | 7.8 ± 8.0 |
| 1-year: Urinations per day | 6.7 ± 2.7 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.
| urinations at night | Overactive Bladder (OAB) - Urinary Frequency (UF) |
|---|---|
| Baseline: Urinations at night | 3.0 ± 2.4 |
| 6-month: Urinations at night | 1.9 ± 2.2 |
| 1-year: Urinations at night | 2.0 ± 2.3 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the degree of urgency leaks experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
| Participants | Overactive Bladder (OAB) - Urinary Urge Incontinence (UUI) |
|---|---|
| Baseline: Average degree of urgency = 0 | 7 |
| Baseline: Average degree of urgency = 1 | 6 |
| Baseline: Average degree of urgency = 2 | 21 |
| Baseline: Average degree of urgency = 3 | 90 |
| Baseline: Average degree of urgency = 4 | 58 |
| 6-month: Average degree of urgency = 0 | 21 |
| 6-month: Average degree of urgency = 1 | 27 |
| 6-month: Average degree of urgency = 2 | 48 |
| 6-month: Average degree of urgency = 3 | 36 |
| 6-month: Average degree of urgency = 4 | 20 |
| 1-year: Average degree of urgency = 0 | 21 |
| 1-year: Average degree of urgency = 1 | 28 |
| 1-year: Average degree of urgency = 2 | 47 |
| 1-year: Average degree of urgency = 3 | 23 |
| 1-year: Average degree of urgency = 4 | 13 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the degree of urgency experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
| Participants | Overactive Bladder (OAB) - Urinary Frequency (UF) |
|---|---|
| Baseline: Average degree of urgency = 0 | 2 |
| Baseline: Average degree of urgency = 1 | 5 |
| Baseline: Average degree of urgency = 2 | 24 |
| Baseline: Average degree of urgency = 3 | 76 |
| Baseline: Average degree of urgency = 4 | 44 |
| 6-month: Average degree of urgency = 0 | 15 |
| 6-month: Average degree of urgency = 1 | 23 |
| 6-month: Average degree of urgency = 2 | 47 |
| 6-month: Average degree of urgency = 3 | 27 |
| 6-month: Average degree of urgency = 4 | 13 |
| 1-year: Average degree of urgency = 0 | 14 |
| 1-year: Average degree of urgency = 1 | 25 |
| 1-year: Average degree of urgency = 2 | 38 |
| 1-year: Average degree of urgency = 3 | 26 |
| 1-year: Average degree of urgency = 4 | 13 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.
| episodes per week | Fecal Incontinence (FI) |
|---|---|
| Baseline: FI episodes per week | 6.3 ± 8.6 |
| 6-month: FI episodes per week | 1.5 ± 2.7 |
| 1-year: FI episodes per week | 2.4 ± 4.1 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.
| days per week | Fecal Incontinence (FI) |
|---|---|
| Baseline: FI days per week | 3.8 ± 2.2 |
| 6-month: FI days per week | 1.1 ± 1.7 |
| 1-year: FI days per week | 1.8 ± 2.3 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the degree of urgency experienced.
| Participants | Fecal Incontinence (FI) |
|---|---|
| Baseline: Average degree of urgency = 0 | 9 |
| Baseline: Average degree of urgency = 1 | 1 |
| Baseline: Average degree of urgency = 2 | 10 |
| Baseline: Average degree of urgency = 3 | 17 |
| Baseline: Average degree of urgency = 4 | 17 |
| 6-month: Average degree of urgency = 0 | 15 |
| 6-month: Average degree of urgency = 1 | 7 |
| 6-month: Average degree of urgency = 2 | 7 |
| 6-month: Average degree of urgency = 3 | 10 |
| 6-month: Average degree of urgency = 4 | 5 |
| 1-year: Average degree of urgency = 0 | 13 |
| 1-year: Average degree of urgency = 1 | 5 |
| 1-year: Average degree of urgency = 2 | 8 |
| 1-year: Average degree of urgency = 3 | 3 |
| 1-year: Average degree of urgency = 4 | 6 |
Change in ICIQ-OABqol scores at follow-up compared to baseline for implanted participants. Questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is considered a minimally important difference (MID).
| score on a scale | Overactive Bladder (OAB) |
|---|---|
| Baseline: Coping | 49.4 ± 27.7 |
| Baseline: Concern | 49.2 ± 25.0 |
| Baseline: Sleep | 53.4 ± 29.0 |
| Baseline: Social | 75.0 ± 22.5 |
| Baseline: HRQL | 55.3 ± 22.3 |
| 6-Month: Coping | 74.8 ± 26.2 |
| 6-Month: Concern | 74.8 ± 25.1 |
| 6-Month: Sleep | 75.1 ± 24.3 |
| 6-Month: Social | 89.1 ± 18.9 |
| 6-Month: HRQL | 77.7 ± 21.2 |
| 1-Year: Coping | 74.3 ± 27.5 |
| 1-Year: Concern | 73.6 ± 25.6 |
| 1-Year Sleep | 77.1 ± 23.0 |
| 1-Year Social | 89.0 ± 18.7 |
| 1-Year: HRQL | 77.9 ± 21.4 |
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UR diagnosis at baseline were asked about the number of catheterizations required per day.
| catheterizations per day | Urinary Retention (UR) |
|---|---|
| Baseline: Catheterizations per day | 0.8 ± 1.8 |
| 6-month: Catheterizations per day | 0.2 ± 0.8 |
| 1-year: Catheterizations per day | 0.2 ± 0.9 |
Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.
| score on a scale | Fecal Incontinence (FI) |
|---|---|
| Baseline CCF-FIS Score | 10.7 ± 4.1 |
| 6-Month: CCF-FIS Score | 6.3 ± 4.5 |
| 1-Year CCF-FIS Score | 6.8 ± 4.9 |
Change in FIQL score compared to baseline for implanted participants. Fecal Incontinence Quality of Life (FIQL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
| score on a scale | Fecal Incontinence (FI) |
|---|---|
| Baseline: Lifestyle | 2.7 ± 1.0 |
| Baseline: Coping/Behavior | 2.1 ± 0.8 |
| Baseline: Depression/Self Perception | 3.0 ± 0.9 |
| Baseline: Embarrassment | 2.2 ± 0.9 |
| 6-Month: Lifestyle | 3.4 ± 0.8 |
| 6-Month: Coping/Behavior | 2.9 ± 0.9 |
| 6-Month: Depression/Self Perception | 3.6 ± 0.8 |
| 6-Month: Embarrassment | 3.0 ± 1.0 |
| 1-Year: Lifestyle | 3.1 ± 1.0 |
| 1-Year: Coping/Behavior | 2.7 ± 0.8 |
| 1-Year: Depression/Self Perception | 3.7 ± 0.7 |
| 1-Year: Embarrassment | 2.7 ± 1.0 |
Change in O'Leary Sant score at follow-up compared to baseline for all implanted participants. The O'Leary Sant is a validated questionnaire designed to provide data on painful bladder and urinary frequency symptoms. Symptom and Problem Index scores are calculated based on responses to two sets of 4 questions with higher scores representing more symptoms/problems. A total score from 0 - 40 is also calculated based on all responses. At follow-up, an O'Leary Sant was only collected for those participants an O'Leary Sant score ≥ 6 at baseline.
| score on a scale | Overactive Bladder (OAB) - Urinary Frequency (UF) |
|---|---|
| Baseline: Total Score | 20.7 ± 6.8 |
| 6-Month: Total Score | 11.7 ± 8.2 |
| 1-Year Total Score | 11.8 ± 7.7 |
Change in AUA-SI score at follow-up compared to baseline for Urinary Retention participants who were implanted with the device. The AUA-SI (American Urological Association Symptom Index) is a questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) in men, with scores ranging from 0 to 35, categorizing symptoms as mild (0-7), moderate (8-19), or severe (20-35). A higher score indicates more severe UR symptoms and a score of greater than 8 indicates moderate to severe UR symptoms.
| score on a scale | Urinary Retention (UR) |
|---|---|
| Baseline: AUA-SI Score | 18.7 ± 8.6 |
| 6-Month: AUA-SI Score | 10.4 ± 8.1 |
| 1-Year: AUA-SI Score | 10.3 ± 8.4 |
The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).
| number of events | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Device-related SAEs | 0 |
| Procedure-related SAEs | 2 |
| Device- and Procedure-related SAEs | 0 |
| SAEs (not device- or procedure-related) | 13 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 1/253 (0.4%) | 14/253 (5.5%) | 20/253 (7.9%) |
| Event | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Transient Ischemic AttackNervous system disorders | 2/253 |
| Acute EncephalopathyNervous system disorders | 1/253 |
| Orthostatic HypotensionBlood and lymphatic system disorders | 1/253 |
| SyncopeNervous system disorders | 1/253 |
| Pain at INS SiteMusculoskeletal and connective tissue disorders | 1/253 |
| Urinary Tract InfectionInfections and infestations | 1/253 |
| HypernatremiaBlood and lymphatic system disorders | 1/253 |
| Chest PainCardiac disorders | 1/253 |
| Exacerbation of Hypokalemic Periodic ParalysisMusculoskeletal and connective tissue disorders | 1/253 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/253 |
| Event | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Uncomfortable/Undesirable StimulationNervous system disorders | 5/253 |
| Implant Site InfectionInfections and infestations | 3/253 |
| Pain at Lead SiteSkin and subcutaneous tissue disorders | 2/253 |
| Pain at INS SiteSkin and subcutaneous tissue disorders | 2/253 |
| Implant Site IndurationSkin and subcutaneous tissue disorders | 1/253 |
| Lead ErosionProduct Issues | 1/253 |
| Lead MigrationProduct Issues | 1/253 |
| Loss of EfficacyNervous system disorders | 1/253 |
| Pain at Contralateral HipMusculoskeletal and connective tissue disorders | 1/253 |
| SciaticaMusculoskeletal and connective tissue disorders | 1/253 |
Characteristics of the Treated study population. Participants in the Treated analysis population are those who were implanted with PNE or tined leads.
| Age, Categorical(Participants) | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 97 |
| >=65 years | 153 |
| Sex: Female, Male(Participants) | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Female | 218 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 240 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Race — African American | 23 |
| Race — American Indian or Alaska Native | 1 |
| Race — Asian | 2 |
| Race — Caucasian | 217 |
| Race — Latino or Hispanic | 5 |
| Race — Other | 1 |
| Race — Declined to state | 1 |
| Region of Enrollment(Participants) | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| United States | 250 |
| BMI(participants) | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| < 18.5 kg/m2 | 2 |
| 18.5-24.9 kg/m2 | 42 |
| 25.0-29.9 kg/m2 | 79 |
| 30.0-34.9 kg/m2 | 60 |
| 35.0-39.9 kg/m2 | 28 |
| >=40.0 kg/m2 | 25 |
| Unknown | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in Oct 2023, 34 months.
Results were first posted in Jun 2025, 1 year 7 months after primary completion.
Of 17 observational studies under Urinary Retention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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