Sacral Neuromodulation for Chronic Pelvic Pain

NCT06150599 | Recruiting DMC FDA Device

• 1 other identifier: 2023-254
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Pelvic Pain Syndrome

Keywords

Women

Outcome Measures

Primary Outcomes (1)

• 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

  Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)

Secondary Outcomes (9)

• The change in central sensitization score over 13 months

  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.

  Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)

• Change in severity of overactive bladder symptoms.

  Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)

• Change in Female Sexual Function

  Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)

• Change in mental health and anxiety.

  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)

Study Arms (1)

SNM for the treatment of CPP

EXPERIMENTAL

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

Interventions

Sacral neuromodulation DEVICE

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

SNM for the treatment of CPP

Eligibility Criteria

• Age: 22 Years - 70 Years
• Gender Eligibility Details: Female with female reproductive organs
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Female, aged 22-70
• Chronic pelvic pain (= pain below umbilicus) score of 4 or greater on 10-point VAS, present for 6 months or greater (screening patient)
• Failed at least 1 or more conservative treatments (e.g. pelvic floor physical therapy, biofeedback, behavioral modification, oral pharmacotherapy, bladder instillations)
• No changes to current regimen of medications for their pelvic pain for \> 4 weeks prior to screening
• 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
• Participant agrees not to start any new treatment interventions for CPP prior to Visit 4 (Primary Endpoint)

You may not qualify if:

• History of any active pelvic cancer
• Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
• 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)
• Any psychiatric or personality disorder at the discretion of the study physician. This does not include depression or generalized anxiety disorders that are stable.
• Current symptomatic urinary tract infection (UTI) or more than 6 UTIs in past year
• Severe or uncontrolled diabetes (A1C \> 7, documented in the last 3 months) or diabetes with peripheral nerve involvement
• 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
• Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial
• Subject with documented history of allergy to titanium, zirconia, polyurethane, epoxy, or silicone
• Implantation of spinal cord stimulator and/or drug delivery pumps, whether turned on or off
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
• Current treatment for active malignancy (skin cancers excluded)
• Patients with spinal pathology that could confound study results. This may include participants with cauda equina syndrome, spinal stenosis, neurogenic claudication, lumbar radiculopathy, patients with primary complaints of leg pain with numbness and or weakness, patients with a primary pain compliant that is vascular in origin, clinical evidence of progressive neurologic pathology, mechanical instability or other spinal pathology that requires surgical intervention, spine or visceral pain secondary to neoplasm, visceral pain in the upper abdomen rather than the pelvis, current diagnosis of fibromyalgia participants with significant cognitive impairment, participants with a condition currently requiring or likely to require use of diathermy or MRI or history of any other condition that in the opinion of the investigator could put the participant at risk or interfere with study results interpretation. (screening patient).
• Participants involved in ongoing litigation and or injury claims or workers compensation claims.
• Participation in a current clinical trial or within the preceding 30 days

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Study Officials

• Kenneth Peters, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Giordano, BSN

CONTACT

248-551-3517; Jennifer.Giordano@corewellhealth.org

Julie Swanson, BSN

CONTACT

248-551-3551; Julie.Swanson2@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Device is turned on/off, or settings are modified throughout the study. The protocol specifies the exact timing of when the device is turned on/off and or settings are modified. All patients will be on the same schedule. To maintain study integrity, patients will not be informed how device settings are changed; however, since this is a single-arm study, "open label" has been chosen above. During the informed consent process, patients will be explained that throughout the study, the device settings will be modified and that some of these changes may result in symptoms improving while others may cause symptoms to worsen.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: Single arm and participant-blinded sequential treatment controlled clinical trial. The device will be turned on or off, and settings adjusted at each visit. To minimize bias throughout the study, patients will be blinded to the device settings; however, since there is only one arm, "open label" has been chosen below.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: June 30, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)