Clinical trial NCT05502614: Dorsal Genital Nerve Stimulation for Bladder Management After SCI
Official title: NEUROMOD UCon: Pilot Study of Dorsal Genital Nerve Stimulation for Management of Bladder Overactivity Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neurogenic Bladder
Neurogenic Detrusor Overactivity
Neurogenic Bladder Dysfunction
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Royal National Orthopaedic Hospital NHS Trust
First posted: 2022-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline (week 1) in Maximum Cystometric capacity at post intervention (week 9) and follow up (week 13).
timeFrame: Week 1, 9 and 13
Secondary outcomes:
measure: Maximum detrusor pressure
timeFrame: Week 1, 9 and 13
measure: 3 day bladder diary (3DBD)
timeFrame: Week 1, 2, 5, 9, 10 and 13
measure: Incontinence Quality of Life (I-QoL) Questionnaire
timeFrame: Week 1, 5, 10 and 13
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
timeFrame: Week 1, 5, 10 and 13
measure: The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire
timeFrame: Week 10
measure: VAS treatment satisfaction
timeFrame: Week 10
measure: Semi structured interview
timeFrame: Week 10
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
state: London
Study officials:
affiliation: University College, London
name: Lynsey Duffell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.