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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries; Neurogenic Bladder; Neurogenic Detrusor Overactivity; Neurogenic Bladder Dysfunction
• Intervention / Treatment: Device: Neuromodulation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • Stanmore, London, United Kingdom, HA7 4LP
      • Royal National Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Royal National Orthopaedic Hospital NHS Trust
• Investigators: Principal Investigator: Lynsey Duffell, PhD, University College, London

Publications and helpful links

General Publications

• Doherty SP, Vanhoestenberghe A, Duffell LD, Hamid R, Knight SL. Ambulatory urodynamic monitoring assessment of dorsal genital nerve stimulation for suppression of involuntary detrusor contractions following spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2020 Apr 30;6(1):30. doi: 10.1038/s41394-020-0279-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Estimated): May 26, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 276171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No