Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
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.
• 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 participation
• Participant agrees not to start any new treatment interventions for CPP prior to Visit 4 (Primary Endpoint)