NCT05502614

Dorsal Genital Nerve Stimulation for Bladder Management After SCI

NEUROMOD UCon: Pilot Study of Dorsal Genital Nerve Stimulation for Management of Bladder Overactivity Following Spinal Cord Injury

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Cord Injuries
• Neurogenic Bladder
• Neurogenic Detrusor Overactivity
• Neurogenic Bladder Dysfunction

Interventions

Type	Name	Description
DEVICE	Neuromodulation	Transcutaneous stimulation of the dorsal genital nerve using the Innocon Medical UCon device to provide on demand relief of bladder spasms

Timeline

• Start date: 2023-01-23
• Primary completion: 2024-02-26
• Completion: 2024-05-26
• First posted: 2022-08-16
• Last updated: 2024-04-26

Locations

1 site across 1 country: United Kingdom