NCT06150599

Sacral Neuromodulation for Chronic Pelvic Pain

Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Corewell Health East · Academic / Other
• Sex: Female
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pelvic Pain Syndrome

Interventions

Type	Name	Description
DEVICE	Sacral neuromodulation	Interstim X, which includes an implantable pulse generator and lead, will be implanted surgically in a single-stage procedure.

Timeline

• Start date: 2025-06-30
• Primary completion: 2028-04-01
• Completion: 2028-12-01
• First posted: 2023-11-29
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study