Dorsal Genital Nerve Stimulation for Bladder Management After SCI

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries, Neurogenic Bladder, Neurogenic Detrusor Overactivity, Neurogenic Bladder Dysfunction

Intervention / Treatment
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* Device: Neuromodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Neuromodulation<br>* Transcutaneous stimulation of the dorsal genital nerve using the Innocon Medical UCon device to provide on demand relief of bladder spasms<br>* Other names: Dorsal Genital Nerve Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (week 1) in Maximum Cystometric capacity at post intervention (week 9) and follow up (week 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. | Week 1, 9 and 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum detrusor pressure | Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder). | Week 1, 9 and 13 | 
| 3 day bladder diary (3DBD) | 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. | Week 1, 2, 5, 9, 10 and 13 | 
| Incontinence Quality of Life (I-QoL) Questionnaire | Validated questionnaire to measure incontinence related quality of life. Scoring is 0 to 100 with higher scores representing greater quality of life. | Week 1, 5, 10 and 13 | 
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | Validated questionnaire to measure general health. . Scoring is 0 to 100 with higher scores representing greater health | Week 1, 5, 10 and 13 | 
| The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire | Validated questionnaire to measure acceptability of the UCon device. Scoring is 1 to 5 with higher scores representing greater acceptance. | Week 10 | 
| VAS treatment satisfaction | Visual analogue scale to assess treatment satisfaction. Scoring is 0 to 10 with higher scores representing greater satisfaction | Week 10 | 
| Semi structured interview | 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. | Week 10 |