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At-Home Genital Nerve Stimulation for SCI Bowel

NCT06836739 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-02

No results posted yet for this study

Summary

The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.

Researchers will:

* Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label
* Compare a target stimulation level to a placebo stimulation level

Participants will:

* Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home
* Visit the research center 3 times to participate in exams and answer questions
* Keep a daily diary of their bowel symptoms and stimulation times

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

Genital nerve stimulation

Genital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Kim Anderson, PhD · MetroHealth System, Ohio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06836739 on ClinicalTrials.gov