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NCT05626816
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
NA trial testing Genital Nerve Stimulation in Fecal Incontinence in 52 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | MetroHealth Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 21 March 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Genital Nerve Stimulation
- Clinical exam
- Collection of SCI common data elements
- Bowel function survey completion
- International Standard for Neurological Classification of SCI (ISNCSCI)
- Response to genital nerve stimulation (GNS)
- Anorectal Manometry testing (ARM)
Conditions studied
- Fecal Incontinence — all drugs for Fecal Incontinence →
Sponsor
MetroHealth Medical Center
Who can join
18 and older, any sex, with Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05626816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Genital Nerve Stimulation
Trials testing the same drug.
- NCT04160793 — Genital Nerve Stimulation - GNS - for Treatment of Non-neurogenic OAB · NA · unknown
- NCT03472599 — Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia · NA · completed
Other recruiting trials for Fecal Incontinence
Currently open trials in the same condition.
- NCT06532123 — Mechanisms of Improving Fecal Continence Muscles Motor Function · NA · recruiting
- NCT05998187 — Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections · Phase 3 · recruiting
- NCT06754189 — Safety and Performance of UCon Patch Electrode · NA · recruiting
- NCT06562140 — Multidimensional Examination of Patients with Colorectal and Anal Cancer · recruiting
- NCT06273046 — Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback · NA · recruiting
Other MetroHealth Medical Center trials
Trials by the same sponsor.
- NCT06734026 — Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury · NA · recruiting
- NCT06664892 — Ultrahypofractionated Whole Breast Radiation Following Chemotherapy · NA · not yet recruiting
- NCT06788795 — Effectiveness of a Wearable Hydration Device · Phase 2 · not yet recruiting
- NCT06836739 — At-Home Genital Nerve Stimulation for SCI Bowel · NA · recruiting
- NCT06113965 — Neural Operant Conditioning · NA · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05626816 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MetroHealth Medical Center
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05626816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing