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Recruiting NCT06836739

At-Home Genital Nerve Stimulation for SCI Bowel

No phase Interventional Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genital nerve stimulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Overview

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

Detailed description

The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.

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.

Primary outcome measures

  • The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. [Time frame: 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. [Time frame: 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. [Time frame: From baseline to the end of 6 weeks]
Secondary outcome measures (7)
  • Anorectal Manometry (ARM) [Time frame: From baseline to the end of 6 weeks]
  • Clinical exam [Time frame: From baseline to the end of 6 weeks]
  • Bowel diary [Time frame: From baseline to the end of 6 weeks.]
  • Stimulation diary [Time frame: From baseline to the end of 6 weeks.]
  • International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1 [Time frame: From baseline to the end of 6 weeks.]
  • SCI-QoL Bowel Management Difficulties (SCI-QoL BMD) [Time frame: From baseline to the end of 6 weeks.]
  • SCI Common Data Elements (CDEs) [Time frame: At baseline.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • MetroHealth Center for Rehabilitation Research — Cleveland

Identifiers

NCT: NCT06836739 · STUDY00000717 · W81XWH2210778 - SC210121 · W81XWH2210781 - SC210121P1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗