NCT06377969NARecruiting

Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain

Stanford University

Start Date

6/1/2025

Completion Date

5/31/2028

Summary

Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: The investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management Exclusion Criteria: * Major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.) * Secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions * Major untreated psychological comorbidities * Anatomical challeneges to place spinal cord stimulator * Ongoing legal or disability claims

Interventions

DEVICE

ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation

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Conditions

Chronic Pelvic Pain Syndrome

Locations

Stanford

Redwood City, California 94063

United States