Spinal Cord InjuriesNEUROMOD UConNCT05502614
Dorsal Genital Nerve Stimulation for Bladder Management After SCI
A study testing Neuromodulation in people with Spinal Cord Injuries and Neurogenic Bladder, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder, Neurogenic Detrusor Overactivity
- What is being tested?
- Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2023to 26 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National Orthopaedic Hospital
Stanmore, London, HA7 4LP
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder, Neurogenic Detrusor Overactivity, Neurogenic Bladder Dysfunction
- Being tested
- Neuromodulation
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationDevice
Also called Dorsal Genital Nerve Stimulation
Transcutaneous stimulation of the dorsal genital nerve using the Innocon Medical UCon device to provide on demand relief of bladder spasms
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, 9 and 13
Secondary outcomes (7)
Maximum detrusor pressure
Maximum recorded detrusor pressure during standard cystometry (retrograde filling of the bladder).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Week 10
VAS treatment satisfaction
Visual analogue scale to assess treatment satisfaction. Scoring is 0 to 10 with higher scores representing greater satisfaction
Measured: 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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start23 Jan 2023
- Primary completion26 Feb 2024
- Study completion26 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lynsey Duffell, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502614
- Sponsor's protocol ID
- 276171
- Acronym
- NEUROMOD UCon
- Status last verified
- Apr 2024
- First submitted
- 9 Aug 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32355163
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROMOD UCon: Pilot Study of Dorsal Genital Nerve Stimulation for Management of Bladder Overactivity Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05502614
- Acronym / sponsor ID
- NEUROMOD UCon / 276171
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder, Neurogenic Detrusor Overactivity, Neurogenic Bladder Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 May 2024 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Neuromodulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- recipient of intra-detrusor botulinum toxin injections within the last 6 months;
- previous surgical intervention on bladder sphincters;
- pregnancy;
- cardiac pacemaker;
- active sepsis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuromodulationAlso: Dorsal Genital Nerve StimulationTranscutaneous stimulation of the dorsal genital nerve using the Innocon Medical UCon device to provide on demand relief of bladder spasms | Device | Treatment |
Primary outcome
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.
7 secondary outcomes
Maximum detrusor pressure
Time frame: Week 1, 9 and 13
3 day bladder diary (3DBD)
Time frame: Week 1, 2, 5, 9, 10 and 13
Incontinence Quality of Life (I-QoL) Questionnaire
Time frame: Week 1, 5, 10 and 13
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Time frame: Week 1, 5, 10 and 13
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire
Time frame: Week 10
VAS treatment satisfaction
Time frame: Week 10
Semi structured interview
Time frame: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Background: PubMed 32355163Doherty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynsey Duffell, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation in people with Spinal Cord Injuries and Neurogenic Bladder, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.