Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
Corewell Health East
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.
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, CP…
Eligibility
- Age range
- 22–70 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DeviceSacral neuromodulation
Interstim X, which includes an implantable pulse generator and lead, will be implanted surgically in a single-stage procedure.
Location
- Corewell Health William Beaumont University HospitalRoyal Oak, Michigan