Sacral Neuromodulation for Chronic Pelvic Pain

Part of paid clinical trials in Royal Oak, Michigan.

Sponsor
Corewell Health East
Study ID
NCT06150599
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain Syndrome

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Sacral neuromodulation — DEVICE
    Interstim X, which includes an implantable pulse generator and lead, will be implanted surgically in a single-stage procedure.

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Dec 2025
Primary completion
Apr 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SNM for the treatment of CPP
    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.

Primary Outcome Measure

The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks. [ Time Frame: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073
Jennifer Giordano, BSN
[email protected]
248-551-3517
Julie Swanson, BSN
[email protected]
248-551-3551
Kenneth Peters, MD (PRINCIPAL_INVESTIGATOR)

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Corewell Health William Beaumont University Hospital· Royal Oak, MI

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