An interventional study of Sacral neuromodulation in Chronic Pelvic Pain Syndrome, sponsored by Corewell Health East. Recruiting at 1 site in United States. Open to female participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Corewell Health East · Not applicable, Interventional, and Treatment
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.
Despite SNM being available for more than 25 years, there are many things about this technology that remain elusive. Enhancing our understanding of SNM in the chronic pelvic pain (CPP) population can rapidly improve the care of current patients suffering from pelvic pain, as well as help develop future technologies, stimulation paradigms, and lead to effective counseling of patients. CPP is one of most common and challenging conditions for clinicians to treat today. CPP is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months. As such, CPP can be caused by numerous underlying conditions from gynecological (e.g. endometriosis), gastrointestinal (e.g. celiac disease, irritable bowel syndrome), urological (e.g. interstitial cystitis), musculoskeletal (e.g. fibromyalgia), prostatitis, and neurological/vascular (e.g. spinal cord injury, ilioinguinal nerve entrapment) origin. From a urological perspective, the pain in CPP syndrome can be associated with symptoms suggesting urinary, sexual or bowel dysfunction, and are commonly associated with Overactive Bladder (OAB) symptoms of urinary frequency, urgency, and incontinence. CPP has a debilitating effect on quality of life, leading to other comorbidities such as depression, anxiety, and sleep disorders. CPP is common in both men and women, but occurs more frequently in women. This study will assess the effectiveness of sacral neuromodulation in women.
This is a prospective single arm and single blinded quasi-placebo controlled study. Patients will be blinded to the device settings. For those that qualify, the sacral neuromodulation device will be placed by an experienced physician. After placement in the operating room the device settings will be adjusted. 2 weeks post-operatively participants return and complete study questionnaires. The devices settings will again be adjusted at this visit. The device may turned on/off, or settings modified throughout the study. To maintain study integrity, patients will not be informed how device settings are changed. At each follow up visit, participants will be asked to complete study questionnaires and will have their device settings adjusted. Participants will follow up over a course of 12 months from the time of device implantation.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Corewell Health East is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Note- to preserve the scientific integrity of the study some criteria have been omitted from this posting. All eligibility criteria will be listed at the close of the study.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7.
Device: Sacral neuromodulation
Interstim X, which includes an implantable pulse generator and lead, will be implanted surgically in a single-stage procedure.
Also known as: SNM, Interstim X
The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
The VAS is a validated tool to determine patient perceived pain. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. The value at Visit 4 (10 weeks post-implant) minus the value at Visit 2 (baseline, 2 weeks post-implant) will be used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain
Time frame: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)
The change in central sensitization score over 13 months
Change in central sensitization will be assessed using the temporal summation test using the TSA2 AIR system. Temporal summation is considered a manifestation of central sensitization and can be assessed using thermal modalities. It is measured as the magnitude of positive slope of the line fitted to the series of 10 stimuli at the target temperature. A larger slope reflects a higher degree of central sensitization. The central sensitization slope at each treatment visit (visits 3 through 8) minus the slope at visit 2 (baseline, 2 weeks post-implementation) will be recorded and analyzed. A positive number reflects more central sensitization, and a negative number reflects less central sensitization.
Time frame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Change in pelvic floor pain using a 10-point VAS pain score.
A trained provider will palpate all 4 quadrants of the pelvis, while recording pain scores for each quadrant. The VAS is a validated questionnaire that assesses pain on a scale from 0 = no pain to 10 = worst possible pain. The subject will provide a pain score from 0 - 10 for each of the 4 quadrants assessed. The average pain score of the 4 quadrants is then calculated. The average pain score ranges from 0 to 10. The difference in value from visit 2 (baseline, 2 weeks post implant) minus visit 8 (an average of 13 months post implant) is calculated. A positive number indicates improvement of symptoms. A negative number indicates worsening of symptoms.
Time frame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Change in severity of overactive bladder symptoms.
The change in OAB symptoms between baseline (visit 2) and subsequent study visits will be assessed using the 6-question Overactive Bladder Questionnaire Short Form (OABq). OABq is a well-established questionnaire used to assess severity of OAB symptoms. The OAB-Q Short Form (SF) consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal. Scores can range from 0 to 100, with higher scores indicating more severe symptoms. The change is calculated from the baseline (visit 2, 2 weeks post-implant) minus the value at visit 8 (an average of 13 months post-implant). A positive number indicates improvement of symptoms. A negative number indicates worsening of symptoms.
Time frame: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
Change in Female Sexual Function
The Female Sexual Function Index (FSFI) is a 19-question questionnaire evaluating female sexual health in several domains: libido, arousal, lubrication, orgasm, satisfaction, and sexual pain. Each subdomain is scored separately, and the total score calculated. Change in FSFI score will be assessed between baseline (visit 2, 2 weeks-post implant) and visit 8 (an average of 13 months post-implant). A lower FSFI score is equivalent to a higher degree of sexual dysfunction. Scores range from 0 to 36. The change value is calculated from visit 8 (approximately 13 months post-implant) minus visit 2 (baseline, 2 weeks post-implant). A positive number indicates improvement of symptoms. A negative number indicates worsening of symptoms.
Time frame: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
Change in mental health and anxiety.
The Pain Catastrophizing Scale (PCS) is used to determine the impact of SNM on mental health related to pain. Pain catastrophizing is the tendency to describe a pain experience in more exaggerated terms than the average person. The PCS is a validated measure of rumination, magnification, and helplessness related to pain. The PCS has been shown to have adequate to excellent internal consistency. People with higher PCS scores have a tendency to be more likely to report their pain as intense than those with low PCS scores. This objective will be measured at visit 4 (10 weeks post-implant), visit 5 (an average of 11-15 weeks post-implant), visit 7 (12 months post-implant) and visit 8 (an average of 13 months post-implant) and compared to visit 2 scores (baseline, 2 weeks post-implant). Each value will be subtracted from baseline and the difference will be reported. A negative number will indicate more pain catastrophizing, and a positive number will indicate less pain catastrophizing.
Time frame: Visit 2 (2 weeks post-implant), Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant)
Patient satisfaction with sacral neuromodulation treatment
Patient satisfaction will be assessed using the Global Response Assessment (GRA) tool on which the patient rates overall patient-perceived symptom improvement on a 7-point scale at visit 4 (10 weeks post-implant) through visit 8 (an average of 13 months post-implant). It is scored as follows: 1 = markedly worse, 2 = moderately worse, 3 = mildly worse, 4 = same (unchanged), 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved. Significant improvement is considered those patient rating their symptoms to be moderately to markedly improved.
Time frame: Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant)
Treatment durability measured as change in pain scores from baseline (visit 2) to visit 7 (12 months post-implant) as measured by 10-point visual-analog scale.
Treatment durability will be assessed using the 10-point Visual Analogue Scale (VAS) for pain. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. The value at Visit 7 (12 months post-implant) minus the value at Visit 2 (baseline, 2 weeks post-implant) will be used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain
Time frame: Visit 2 (2 weeks post-implant) and Visit 7 (12 months post-implant)
Number of days of carry-over effect after short and long treatment (an average of 13 months post implant)
This objective will be assessed by counting the number of days after visit 7 (12 months post-implant) until the patient reports pain scores that are consistently worsening (prompting the need for an inperson follow-up visit) than reported at visit 2 (baseline, 2 weeks post-implant). This will indicate how long the treatment effect lasts after treatment has been discontinued.
Time frame: Visit 8 (an average of 13 months post-implant)
Safety and tolerability: number of adverse events related to the device implantation.
Safety and tolerability of sacral neuromodulation in chronic pelvic pain patients will be assessed by recording the number of adverse events that are determined to be related to device implantation. Adverse events will be assessed at each scheduled study visit or as reported by patients outside study visits.
Time frame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
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