Actively Recruiting
Sacral Neuromodulation for Chronic Pelvic Pain
Led by Corewell Health East · Updated on 2025-12-11
25
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sacral Neuromodulation for Chronic Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and available for the entire study duration
- Female aged between 22 and 70 years
- Chronic pelvic pain below the umbilicus with a pain score of 4 or greater on a 10-point scale, present for 6 months or more
- Failed at least one conservative treatment such as pelvic floor physical therapy, biofeedback, behavioral modification, oral medications, or bladder instillations
- No changes in pelvic pain medications for more than 4 weeks before screening
- Use of highly effective contraception for at least 1 month prior to screening and agreement to continue during the study for females of reproductive potential
- Agreement not to start any new treatments for chronic pelvic pain before the primary endpoint visit (Visit 4)
You will not qualify if you...
- History of any active pelvic cancer
- Significant medical conditions interfering with the study or device function
- Use of pain management treatments in the past 3 months that could mask study effects
- Psychiatric or personality disorders as determined by the physician, excluding stable depression or anxiety
- Current symptomatic urinary tract infection or more than 6 UTIs in the past year
- Severe or uncontrolled diabetes or diabetes with peripheral nerve involvement
- Diagnosis of interstitial cystitis with Hunner's lesions
- Previous sacral neuromodulation device implantation or participation in a related trial
- Allergy to titanium, zirconia, polyurethane, epoxy, or silicone
- Presence of spinal cord stimulator or drug delivery pumps
- Breastfeeding or pregnant females without adequate contraception
- Ongoing treatment for active malignancy (except skin cancers)
- Spinal pathologies or conditions that may affect study results
- Involvement in ongoing litigation or injury claims
- Participation in another clinical trial within the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
Research Team
J
Jennifer Giordano, BSN
CONTACT
J
Julie Swanson, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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