Dorsal Genital Nerve Stimulation for Bladder Management After SCI (NEUROMOD UCon)

University College London (UCL)

Status: Active, not recruiting

Conditions: Spinal Cord Injuries; Neurogenic Bladder; Neurogenic Bladder Dysfunction; Neurogenic Detrusor Overactivity

Treatments: Device: Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05502614

276171

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spinal Cord Injury (suprasacral, AIS A-D);
• >18 years old, no upper age limit;
• SCI sustained >6 months ago;
• NDO;
• Capable of using the device at home either independently or with existing support.
• Male or female
• Willing and able to provide informed consent

Exclusion criteria

• recipient of intra-detrusor botulinum toxin injections within the last 6 months;
• previous surgical intervention on bladder sphincters;
• pregnancy;
• cardiac pacemaker;
• active sepsis;
• history of significant autonomic dysreflexia;
• poorly controlled epilepsy;
• patients with a cancerous tumour in the area of electrical stimulation

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: Neuromodulation