Dorsal Genital Nerve Stimulation for Bladder Management After SCI

Not Applicable

Active, not recruiting

• Conditions: Neurogenic Bladder; Neurogenic Detrusor Overactivity; Neurogenic Bladder Dysfunction; Spinal Cord Injuries
• Interventions: Device: Neuromodulation

• Registration Number: NCT05502614
• Lead Sponsor: University College, London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-16
• Study Start: 2023-01-23
• Primary Completion: 2024-02-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Study Completion: 2024-05-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Neuromodulation	-

Primary Outcome Measures

Name	Time	Method
Change from baseline (week 1) in Maximum Cystometric capacity at post intervention (week 9) and follow up (week 13).	Week 1, 9 and 13	During standard cystometry (retrograde filling of the bladder), maximum cystometric capacity will be defined as the volume emptied from the bladder after each fill.

Secondary Outcome Measures

Name	Time	Method
3 day bladder diary (3DBD)	Week 1, 2, 5, 9, 10 and 13	3DBDs will be completed on clinically used bladder diaries. Participants will record voided volumes, urinary and faecal incontinence episodes and daily spasticity for 3 days. This will involve measuring the volume voided each time they urinate over the three days, using provided measuring equipment.
VAS treatment satisfaction	Week 10	Visual analogue scale to assess treatment satisfaction. Scoring is 0 to 10 with higher scores representing greater satisfaction
Semi structured interview	Week 10	The research team will conduct a semi-structured interview with the participant to explore further their experience of using DGNS and gain any insights into its use and effects we were unable to obtain from study outcome measures.
Maximum detrusor pressure	Week 1, 9 and 13	Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder).
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire	Week 1, 5, 10 and 13	Validated questionnaire to measure general health. . Scoring is 0 to 100 with higher scores representing greater health
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire	Week 10	Validated questionnaire to measure acceptability of the UCon device. Scoring is 1 to 5 with higher scores representing greater acceptance.
Incontinence Quality of Life (I-QoL) Questionnaire	Week 1, 5, 10 and 13	Validated questionnaire to measure incontinence related quality of life. Scoring is 0 to 100 with higher scores representing greater quality of life.

Trial Locations

Locations (1)

Royal National Orthopaedic Hospital; 🇬🇧 Stanmore, London, United Kingdom