Dorsal Genital Nerve Stimulation for Bladder Management After SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2024-05-26

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.

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Detailed Description

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Conditions

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Spinal Cord Injuries Neurogenic Bladder Neurogenic Detrusor Overactivity Neurogenic Bladder Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Neuromodulation

Intervention Type DEVICE

Transcutaneous stimulation of the dorsal genital nerve using the Innocon Medical UCon device to provide on demand relief of bladder spasms

Interventions

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Neuromodulation

Transcutaneous stimulation of the dorsal genital nerve using the Innocon Medical UCon device to provide on demand relief of bladder spasms

Intervention Type DEVICE

Other Intervention Names

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Dorsal Genital Nerve Stimulation

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No