Using sacral neuromodulation to treat chronic pelvic pain in women

Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain

This study is testing a new treatment called sacral neuromodulation to see if it can help women aged 22-70 with chronic pelvic pain feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 22 Years to 70 Years
• Sex: Female
• Sponsor: Corewell Health East (Academic / other)
• Locations: 1 site (Royal Oak, Michigan)
• Trial ID: NCT06150599 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sacral neuromodulation (SNM), a minimally invasive treatment, for women suffering from chronic pelvic pain (CPP). Participants will undergo a single device implant procedure to assess pain relief and improvement in quality of life. The study aims to enhance understanding of SNM's impact on CPP, which is a complex condition often associated with various underlying health issues. By focusing on women aged 22-70 who have not responded to conservative treatments, the study seeks to provide valuable insights into this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are women aged 22-70 with chronic pelvic pain lasting over 6 months and a pain score of 4 or greater on a 10-point scale.

Not a fit: Patients who have not previously tried conservative treatments for their pelvic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic pelvic pain and improve the quality of life for affected women.

How similar studies have performed: While sacral neuromodulation has been effective for urinary and fecal incontinence, its application for chronic pelvic pain is less explored, making this a novel approach.

Eligibility criteria

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 malignancy (skin cancers excluded)
13. 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).
14. Participants involved in ongoing litigation and or injury claims or workers compensation claims.
15. Participation in a current clinical trial or within the preceding 30 days

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.

Where this trial is running

Royal Oak, Michigan

• Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Kenneth Peters, MD — Corewell Health William Beaumont University Hospital
• Study coordinator: Jennifer Giordano, BSN

Conditions Chronic Pelvic Pain Syndrome; Women