At-Home Genital Nerve Stimulation for SCI Bowel

NCT06836739 | Recruiting FDA Device

• 3 other identifiers: STUDY00000717W81XWH2210778 - SC210121W81XWH2210781 - SC210121P1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fecal incontinence; neurogenic bowel; tetraplegia; paraplegia; paralysis; electrical stimulation; neuromodulation; bowel; feasibility; anorectal manometry

Outcome Measures

Primary Outcomes (3)

• The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

  The 1st feasibility measure bench mark will be the proportion of enrolled who complete the full stimulation protocol.

  From baseline to the end of 6 weeks

• The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

  The 2nd feasibility measure bench mark will be the number of occurrences of unblinding.

  From baseline to the end of 6 weeks

• The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD.

  The 3rd feasibility measure bench mark will be the retention rate.

  From baseline to the end of 6 weeks

Secondary Outcomes (7)

• Anorectal Manometry (ARM)

  From baseline to the end of 6 weeks

• Clinical exam

  From baseline to the end of 6 weeks

• Bowel diary

  From baseline to the end of 6 weeks.

• Stimulation diary

  From baseline to the end of 6 weeks.

• International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1

  From baseline to the end of 6 weeks.

Other Outcomes (2)

• Treatment questionnaire

  At the end of 6 weeks.

• Study exit questionnaire

  At the end of 6 weeks.

Study Arms (2)

Target genital nerve stimulation

EXPERIMENTAL

Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.

Device: Genital nerve stimulation

Sham genital nerve stimulation

SHAM COMPARATOR

Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.

Device: Genital nerve stimulation

Interventions

Genital nerve stimulation DEVICE

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.

Sham genital nerve stimulation; Target genital nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic SCI.
• Minimum of 6 months' post-injury.
• Aged 18 years and older.
• Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
• Score of 14 or higher on the ISCI BF BDS v2.1.
• Response to genital nerve stimulation able to be elicited upon screening.
• Able to understand and provide informed consent.

You may not qualify if:

• Currently enrolled in another functional electrical stimulation (FES) research trial.
• Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
• Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.
• In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

MetroHealth Center for Rehabilitation Research

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Fecal Incontinence; Neurogenic Bowel; Quadriplegia; Paraplegia; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Anderson, PhD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayson Moore

CONTACT

216-957-3518; mmoore12@metrohealth.org

Megan Hammond Nechols

CONTACT

216-957-3562; mhammond1@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 12 months of the end of study.
• Access Criteria: Based on ICPSR guidelines.

Locations

US (1)