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NCT05502614: NEUROMOD UCon
Dorsal Genital Nerve Stimulation for Bladder Management After SCI
NA trial testing Neuromodulation in Spinal Cord Injuries in 10 participants. Participants enrolled and being followed up; not accepting new ones.
26 February 2024
Quick facts
| Lead sponsor | University College, London |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 23 January 2023 |
| Primary completion | 26 February 2024 |
| Estimated completion | 26 May 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Neuromodulation
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
- Neurogenic Bladder — all drugs for Neurogenic Bladder →
- Neurogenic Detrusor Overactivity — all drugs for Neurogenic Detrusor Overactivity →
- Neurogenic Bladder Dysfunction — all drugs for Neurogenic Bladder Dysfunction →
Sponsor
University College, London
Who can join
18 and older, any sex, with Spinal Cord Injuries or Neurogenic Bladder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Following spinal cord injury signals between the brain and the bladder are disrupted. As a result the bladder often becomes overactive which can lead to the need for frequent trips to the toilet, regular incontinence episodes and a decreased quality-of-life. Neuromodulation is a therapy that aims to target the nerves that become overactive controlling the bladder, stopping the bladder overactivity on demand using an external (non-invasive) nerve stimulation box and sticker electrodes placed on the penis or clitoris. This study is a pilot study that aims to investigate neuromodulation for improving symptoms of bladder overactivity when used by 10 people over eight weeks at home. We will assess whether using the device improves bladder capacity, incontinence, frequency of needing the toilet and whether there are any longer lasting changes after 8 weeks. Finally, the study will aim to find out the acceptability of using this type of therapy for participants and the acceptability of the device we are using. Participants in this trial will participate over 13 weeks and need to visit our centre in Stanmore to have urodynamics tests in the 1st, 9th and 13th week. At home they will use a small stimulation device on a daily basis for 8 weeks to control overactivity in the bladder. Whilst at home they will record relevant outcomes in several three-day diaries and questionnaires. They will record baseline data before starting stimulation and for 4 weeks after.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05502614
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Neuromodulation
Trials testing the same drug.
- NCT07266662 — Comparative Effects of Sensory Augmentation and Neuromodulation on Enhancing Motor Recovery Among Stroke Survivors · NA · recruiting
- NCT07165392 — Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Muscul · NA · not yet recruiting
- NCT07165379 — Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Muscul · NA · not yet recruiting
- NCT06783374 — Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence · NA · recruiting
- NCT06193278 — Individual Neuromodulation for PDS · NA · unknown
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
- NCT07109804 — Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury · NA · recruiting
- NCT07472985 — Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial · NA · recruiting
- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other University College, London trials
Trials by the same sponsor.
- NCT07386652 — Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia · NA · not yet recruiting
- NCT06924086 — The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial · NA · recruiting
- NCT07386678 — Study of Imaging and Molecular Biomarkers in Uncomplicated Rhegmatogenous Retinal Detachment · not yet recruiting
- NCT07414940 — ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium · Phase 1, PHASE2 · not yet recruiting
- NCT07214454 — TCDS for the Treatment of Chronic Migraine · NA · not yet recruiting
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 NCT05502614 (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 University College, London
- Last refreshed: 26 April 2024
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/NCT05502614.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing