Clinical trial NCT02239796: Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
Official title: A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Urinary Incontinence
Keywords: transcutaneous posterior tibial nerve stimulation
Randomised controlled trial
Feasibility
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: The Stroke Association, United Kingdom
name: University of Central Lancashire
name: Nursing, Midwifery & Allied Health Professions Research Unit
name: NHS Greater Glasgow and Clyde
name: NHS Lanarkshire
First posted: 2014-09-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To aim of this study is to establish the feasibility of undertaking a phase III trial of transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate stroke-related urinary incontinence.

Detailed description: Stroke-related urinary incontinence (UI) persists in more than one third of stroke survivors. It is associated with significant burden including reduced quality of life, increased morbidity and disability. Urgency UI, together with overactive bladder (OAB) symptoms (frequency, urgency, nocturia), is most commonly experienced. Current continence care is limited to lifestyle advice and behavioural interventions such as voiding programmes. There is a reliance on containment approaches and a lack of available options for active treatment. Intermittent electrical stimulation of the posterior tibial nerve (TPTNS) is effective for treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population. This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a programme of TPTNS over a six week period. Bladder function, associated healthcare costs and quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation will be conducted. Pilot RCT and process evaluation results will inform the design of a phase III RCT of TPTNS to treat urinary incontinence in the stroke population.

Eligibility criteria: Inclusion Criteria:

* Men or women aged ≥ 18 years, with a diagnosis of stroke based on the WHO criteria (WHO 1989) and stroke-related urinary incontinence of at least once weekly.
* Onset of stroke ≥ 4 weeks previously and discharged from hospital to own home following a new stroke episode within the previous 6 months.
* Physically, cognitively and communicatively able and willing to learn to apply TPTNS or has carer who is able and willing to learn.

Exclusion Criteria:

* Pre-existing urinary incontinence prior to stroke.
* Current Urinary Tract Infection.
* Voiding dysfunction requiring intermittent/indwelling catheterisation.
* Cardiac pacemaker in situ.
* Concurrent neurological diagnosis eg dementia, Multiple Sclerosis, diabetic neuropathy.
* Reduced/absent sensation at electrode placement sites.
* Post-void residual urine volume of \> 150ml.

Primary outcomes:
measure: Frequency of reported episodes of urinary incontinence as a measure of effectiveness.
timeFrame: Up to 16 months
Secondary outcomes:
measure: Changes in the severity of urinary incontinence episodes experienced.
timeFrame: Up to 16 months
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: Up to 16 months
measure: Changes in severity of urinary urgency, frequency and nocturia.
timeFrame: Up to 16 months
measure: Urinary symptoms experienced on the American Urological Association Symptom Index
timeFrame: Up to 16 months
measure: Mean Urgency Perception Scores recorded on a 3 day bladder diary
timeFrame: Up to 16 months
measure: Patient Perception of Bladder Condition
timeFrame: Up to 16 months
measure: Severity of bowel symptoms
timeFrame: Up to 16 months
measure: Patient Perception of Bowel Condition
timeFrame: up to 16 months
measure: Changes in post-void residual urine volume.
timeFrame: Up to 16 months
measure: Amount of urine leakage in 24 hours
timeFrame: Up to 16 months
measure: Participants perception of independence from any help with activities of daily living
timeFrame: Up to 16 months
Other outcomes:
Locations:
city: Ayrshire
country: United Kingdom
facility: NHS Ayrshire and Arran
city: Glasgow
country: United Kingdom
facility: NHS Lanarkshire
Study officials:
affiliation: Glasgow Caledonian University
name: Joanne Booth
role: PRINCIPAL_INVESTIGATOR
References: