Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence (TREAT-UI)

• ClinicalTrials.gov Identifier: NCT02239796
• Recruitment Status: Completed
• First Posted: September 15, 2014
• Last Update Posted: May 26, 2016
• Sponsor: Glasgow Caledonian University
• Collaborators: The Stroke Association, United Kingdom; University of Central Lancashire; Nursing, Midwifery & Allied Health Professions Research Unit; NHS Greater Glasgow and Clyde; NHS Lanarkshire
• Information provided by (Responsible Party): Glasgow Caledonian University

Tracking Information

• First Submitted Date: August 12, 2014
• First Posted Date: September 15, 2014
• Last Update Posted Date: May 26, 2016
• Study Start Date: September 2014
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2014)

Frequency of reported episodes of urinary incontinence as a measure of effectiveness. [ Time Frame: Up to 16 months ]

Positive response to International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI SF). This outcome will be the primary outcome for a future full evaluation trial, should it prove feasible.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 9, 2015)

• Changes in the severity of urinary incontinence episodes experienced. [ Time Frame: Up to 16 months ]
• Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: Up to 16 months ]
• Changes in severity of urinary urgency, frequency and nocturia. [ Time Frame: Up to 16 months ]
  By completion of AUASI
• Urinary symptoms experienced on the American Urological Association Symptom Index [ Time Frame: Up to 16 months ]
• Mean Urgency Perception Scores recorded on a 3 day bladder diary [ Time Frame: Up to 16 months ]
• Patient Perception of Bladder Condition [ Time Frame: Up to 16 months ]
• Severity of bowel symptoms [ Time Frame: Up to 16 months ]
• Patient Perception of Bowel Condition [ Time Frame: up to 16 months ]
• Changes in post-void residual urine volume. [ Time Frame: Up to 16 months ]
• Amount of urine leakage in 24 hours [ Time Frame: Up to 16 months ]
• Participants perception of independence from any help with activities of daily living [ Time Frame: Up to 16 months ]
  Measured by completion of the Barthel Index Score and Modified Rankin Score.

Original Secondary Outcome Measures (submitted: September 11, 2014)

• Changes in the severity of urinary incontinence episodes experienced. [ Time Frame: Up to 16 months ]
• Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: Up to 16 months ]
• Changes in severity of urinary urgency, frequency and nocturia. [ Time Frame: Up to 16 months ]
  By completion of AUASI
• Urinary symptoms experienced on the American Urological Association Symptom Index [ Time Frame: Up to 16 months ]
• Mean Urgency Perception Scores recorded on a 3 day bladder diary [ Time Frame: Up to 16 months ]
• Patient Perception of Bladder Condition [ Time Frame: Up to 16 months ]
• Severity of bowel symptoms [ Time Frame: Up to 16 months ]
• Patient Perception of Bowel Condition [ Time Frame: up to 16 months ]
• Changes in Barthel Index Score [ Time Frame: Up to 16 months ]
• Changes in Modified Rankin Score [ Time Frame: up to 16 months ]
• Changes in post-void residual urine volume. [ Time Frame: Up to 16 months ]
• Amount of urine leakage in 24 hours [ Time Frame: Up to 16 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Stroke
• Urinary Incontinence

Intervention

• Device: NeuroTrac continence stimulators

  Electrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact.

  Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators.

• Device: NeuroTrac continence stimulators
  We are using NeuroTrac continence stimulators.

Study Arms

• Experimental: TPTNS

  12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period using a NeuroTrac continence stimulator.

  Two surface electrodes are applied to the non-hemiparetic ankle, where appropriate, or the right ankle where no hemiparesis exists. The electrical stimulator is pre-programmed to safely deliver 30 minutes of continuous stimulation with a pulse frequency of 10 hertz and pulse width 200µs22. The intensity of the current will depend on the stroke survivor's perception threshold and individual comfort and is self-adjusted at each session, but will normally range between 15 and 40 milliamps.

  Intervention: Device: NeuroTrac continence stimulators
• Sham Comparator: Sham TPTNS

  The sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks NeuroTrac continence stimulator.

  The surface electrodes will be positioned on the lateral malleolar area of the ankle, not the medial aspect, to avoid the posterior tibial nerve.

  The stimulation intensity will be increased until sensation is reported, then turned down to 4mA for the 30 minute session, ensuring that despite avoiding the posterior tibial nerve, there is no therapeutic stimulation provided.

  Intervention: Device: NeuroTrac continence stimulators

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 25, 2016): 54
• Original Estimated Enrollment (submitted: September 11, 2014): 80
• Actual Study Completion Date: May 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02239796
• Other Study ID Numbers: TSA 2013/05
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Glasgow Caledonian University
• Original Responsible Party: Same as current
• Current Study Sponsor: Glasgow Caledonian University
• Original Study Sponsor: Same as current

Collaborators

• The Stroke Association, United Kingdom
• University of Central Lancashire
• Nursing, Midwifery & Allied Health Professions Research Unit
• NHS Greater Glasgow and Clyde
• NHS Lanarkshire

Investigators

• Principal Investigator: Joanne Booth; Glasgow Caledonian University

• PRS Account: Glasgow Caledonian University
• Verification Date: February 2016