Sacral Neuromodulation for Chronic Pelvic Pain
ConditionChronic Pelvic Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-70
SponsorCorewell Health East
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sacral neuromodulation
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov