NEUROMOD UCon
Research type
Research Study
Full title
Pilot study of dorsal genital nerve stimulation for management of bladder overactivity following spinal cord injury
IRAS ID
276171
Contact name
Lynsey Duffell
Contact email
Duration of Study in the UK
0 years, 10 months, 28 days
Research 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.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0155
Date of REC Opinion
16 Aug 2022
REC opinion
Further Information Favourable Opinion