Dorsal Genital Nerve Stimulation for Bladder Management After SCI

NCT05502614 | Active Not Recruiting

• 1 other identifier: 276171
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximum detrusor pressure

  Week 1, 9 and 13

• 3 day bladder diary (3DBD)

  Week 1, 2, 5, 9, 10 and 13

• Incontinence Quality of Life (I-QoL) Questionnaire

  Week 1, 5, 10 and 13

• EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

  Week 1, 5, 10 and 13

• The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire

  Week 10

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Neuromodulation

Interventions

Neuromodulation DEVICE

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

Also known as: Dorsal Genital Nerve Stimulation

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Royal National Orthopaedic Hospital NHS Trust: collaborator

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, London, HA7 4LP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32355163 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Lynsey Duffell, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 16, 2022
• Study Start: January 23, 2023
• Primary Completion: February 26, 2024
• Study Completion: May 26, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)