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New treatment option for Chronic Pelvic Pain Syndrome
Official title Sacral Neuromodulation for Chronic Pelvic Pain
ClinicalTrials.gov ID: NCT06150599
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70, women only
You may be able to join 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...
You likely can't join 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...
- Concurrent pain management strategies within the past 3 months that may interfere or mask study intervention (e.g. pelvic floor physical therapy...
- Any psychiatric or personality disorder at the discretion of the study physician. This does not include depression or generalized anxiety disorders...
- 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
See the full eligibility criteria
- 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...
- Participant agrees not to start any new treatment interventions for CPP prior to Visit 4 (Primary Endpoint)
- 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...
- 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...
- 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 Note- to preserve the scientific integrity of the study some criteria have been omitted from this posting. All eligibility criteria will be...
The study team makes the final eligibility decision.
Where it's taking place
- Royal Oak, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Royal Oak, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.