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Sacral Neuromodulation for Chronic Pelvic Pain

RecruitingNot applicableNCT06150599
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
Interventions
  • Device: Sacral neuromodulation
Sponsor
Corewell Health East
Start date
2026-01-27
Primary completion
2028-04-01
Sex
Female
Age range
from 22 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Female, aged 22-70 4. Chronic pelvic pain (= pain below umbilicus) score of 4 or greater on 10-point VAS, present for 6 months or greater (screening patient) 5. Failed at least 1 or more conservative treatments (e.g. pelvic floor physical therapy, biofeedback, behavioral modification, oral pharmacotherapy, bladder instillations) 6. No changes to current regimen of medications for their pelvic pain for \> 4 weeks prior to screening 7. For females of reproductive potential: use of highly effective contraception (e.g. licensed hormonal or barrier methods), for at least 1 month prior to screening and agreement to use such a method during study participation 8. Participant agrees not to start any new treatment interventions for CPP prior to Visit 4 (Primary Endpoint) Exclusion Criteria: 1. History of any active pelvic cancer 2. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints 3. Concurrent pain management strategies within the past 3 months that may interfere or mask study intervention (e.g. pelvic floor physical therapy, shockwave therapy, trigger point injections, bladder instillations) 4. Any psychiatric or personality disorder at the discretion of the study physician. This does not include depression or generalized anxiety disorders that are stable. 5. Current symptomatic urinary tract infection (UTI) or more than 6 UTIs in past year 6. Severe or uncontrolled diabetes (A1C \> 7, documented in the last 3 months) or diabetes with peripheral nerve involvement 7. Interstitial cystitis diagnosis with Hunner's lesions as this is a severe inflammatory bladder condition that can only be treated with eradication of the lesions or a cystectomy. SNM would be be expected to help for IC with Hunner's lesions 8. Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial 9. Subject with documented history of allergy to titanium, zirconia, polyurethane, epoxy, or silicone 10. Implantation of spinal cord stimulator and/or drug delivery pumps, whether turned on or off 11. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception 12. Current treatment for active malignan…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06150599