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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05502614
Recruitment Status : Recruiting
First Posted : August 16, 2022
Last Update Posted : January 26, 2023
Sponsor:
Collaborator:
Royal National Orthopaedic Hospital NHS Trust
Information provided by (Responsible Party):
University College, London

Study Description
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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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neurogenic Bladder Neurogenic Detrusor Overactivity Neurogenic Bladder Dysfunction Device: Neuromodulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: NEUROMOD UCon: Pilot Study of Dorsal Genital Nerve Stimulation for Management of Bladder Overactivity Following Spinal Cord Injury
Actual Study Start Date : January 23, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Dorsal Genital Nerve Stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline (week 1) in Maximum Cystometric capacity at post intervention (week 9) and follow up (week 13). [ Time Frame: 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 :
  1. Maximum detrusor pressure [ Time Frame: Week 1, 9 and 13 ]
    Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder).

  2. 3 day bladder diary (3DBD) [ Time Frame: 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.

  3. Incontinence Quality of Life (I-QoL) Questionnaire [ Time Frame: 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.

  4. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire [ Time Frame: Week 1, 5, 10 and 13 ]
    Validated questionnaire to measure general health. . Scoring is 0 to 100 with higher scores representing greater health

  5. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire [ Time Frame: Week 10 ]
    Validated questionnaire to measure acceptability of the UCon device. Scoring is 1 to 5 with higher scores representing greater acceptance.

  6. VAS treatment satisfaction [ Time Frame: Week 10 ]
    Visual analogue scale to assess treatment satisfaction. Scoring is 0 to 10 with higher scores representing greater satisfaction

  7. Semi structured interview [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05502614


Contacts
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Contact: Lynsey Duffell, PhD 02083853787 l.duffell@ucl.ac.uk
Contact: Sean Doherty, PhD 02083853787 sean.doherty.15@ucl.ac.uk

Locations
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United Kingdom
Royal National Orthopaedic Hospital Recruiting
Stanmore, London, United Kingdom, HA7 4LP
Contact: Sarah Knight, PhD       sarah.knight23@nhs.net   
Sponsors and Collaborators
University College, London
Royal National Orthopaedic Hospital NHS Trust
Investigators
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Principal Investigator: Lynsey Duffell, PhD University College, London
More Information
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Publications:

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT05502614    
Other Study ID Numbers: 276171
First Posted: August 16, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Neurogenic
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