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

Stanford University

Status: Begins enrollment in 2 months

Conditions: Chronic Pelvic Pain Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06377969

75269

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Other group

Description:

Patient will go through trial of spinal cord stimulator. If trial results in \>50% reduction in pain, they will receive implantable spinal cord stimulator

Treatment:

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