NCT05373667

A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: EPC Education s.r.o. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

Prospective observational assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with neuropathic pelvic pain.

Detailed description

The objective of a clinical trial is an assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with localized (not widespread pain), predominant neuropathic pelvic pain neuropathic pain (determined by PAIN-DETECT and rule out musculature pain). Etiologies of CPP to be studied include but not limited to vulvodynia, perineal pain, perianal pain, bladder pain syndrome, and pelvic pain resulting from colorectal procedures. Medical review of the subjects will be done by a multidisciplinary team consisting of urologists/ gynecologists, interventional pain physicians, and psychiatrists. Enrolled centers are National Hospital For Neurology and Neurosurgery in London in the United Kingdom, EuroPainClinics® with centers in Bratislava, Košice, and Bardejov in the Slovac republic and also EuroPainClinics® with centers Praha, Brno, Ostrava, and Hradec Kralove in the Czech republic. Lead placement: To be determined as a function of pain distribution. Lead placement will be either retrograde or anterograde determined by the investigator. Study Duration: The expected duration of this study is approximately 12 months. Enrollment is expected to last 6 months, with subjects followed up to a 12 month period following permanent implant. The time commitment for a subject to complete the study is approximately 13 months; consisting of Baseline assessments, and last follow-up at 12 months. Study Design: This is a single-center, single-arm, prospective, observational post-market study to assess the safety and effectiveness of the Senza System in subjects with chronic pelvic pain. Subjects are acting as his/her own control. Data at follow-up visits will be compared to the subjects' baseline data. Study Objective: The objective of this observational study is to assess the safety and effectiveness of the Spinal cord stimulation, in the treatment of Chronic Pelvic Pain at the study follow-up visits at 1, 3, 6, 9 and 12 months.

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
PROCEDURE	Spinal Cord Stimulation (SCS)	Spinal Cord Stimulation (SCS) - High Frequency at 10 kHz

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2025-05-01
• First posted: 2022-05-13
• Last updated: 2022-05-13