Clinical trial NCT06150599: Sacral Neuromodulation for Chronic Pelvic Pain
Official title: Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Keywords: Women
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Despite SNM being available for more than 25 years, there are many things about this technology that remain elusive. Enhancing our understanding of SNM in the chronic pelvic pain (CPP) population can rapidly improve the care of current patients suffering from pelvic pain, as well as help develop future technologies, stimulation paradigms, and lead to effective counseling of patients. CPP is one of most common and challenging conditions for clinicians to treat today. CPP is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months. As such, CPP can be caused by numerous underlying conditions from gynecological (e.g. endometriosis), gastrointestinal (e.g. celiac disease, irritable bowel syndrome), urological (e.g. interstitial cystitis), musculoskeletal (e.g. fibromyalgia), prostatitis, and neurological/vascular (e.g. spinal cord injury, ilioinguinal nerve entrapment) origin. From a urological perspective, the pain in CPP syndrome can be associated with symptoms suggesting urinary, sexual or bowel dysfunction, and are commonly associated with Overactive Bladder (OAB) symptoms of urinary frequency, urgency, and incontinence. CPP has a debilitating effect on quality of life, leading to other comorbidities such as depression, anxiety, and sleep disorders. CPP is common in both men and women, but occurs more frequently in women. This study will assess the effectiveness of sacral neuromodulation in women.

This is a prospective single arm and single blinded quasi-placebo controlled study. Patients will be blinded to the device settings. For those that qualify, the sacral neuromodulation device will be placed by an experienced physician. After placement in the operating room the device settings will be adjusted. 2 weeks post-operatively participants return and complete study questionnaires. The devices settings will again be adjusted at this visit. The device may turned on/off, or settings modified throughout the study. To maintain study integrity, patients will not be informed how device settings are changed. At each follow up visit, participants will be asked to complete study questionnaires and will have their device settings adjusted. Participants will follow up over a course of 12 months from the time of device implantation.

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.

Primary outcomes:
measure: The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
timeFrame: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)
Secondary outcomes:
measure: The change in central sensitization score over 13 months
timeFrame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
measure: Change in pelvic floor pain using a 10-point VAS pain score.
timeFrame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
measure: Change in severity of overactive bladder symptoms.
timeFrame: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
measure: Change in Female Sexual Function
timeFrame: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
measure: Change in mental health and anxiety.
timeFrame: 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)
measure: Patient satisfaction with sacral neuromodulation treatment
timeFrame: 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)
measure: Treatment durability measured as change in pain scores from baseline (visit 2) to visit 7 (12 months post-implant) as measured by 10-point visual-analog scale.
timeFrame: Visit 2 (2 weeks post-implant) and Visit 7 (12 months post-implant)
measure: Number of days of carry-over effect after short and long treatment (an average of 13 months post implant)
timeFrame: Visit 8 (an average of 13 months post-implant)
measure: Safety and tolerability: number of adverse events related to the device implantation.
timeFrame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
Study officials:
affiliation: Corewell Health William Beaumont University Hospital
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: