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Completed

NCT Number: NCT02239796

Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Ayrshire and Arran, Ayrshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NeuroTrac continence stimulators

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in the severity of urinary incontinence episodes experienced.

    Time frame: Up to 16 months

  2. Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: Up to 16 months

  3. Changes in severity of urinary urgency, frequency and nocturia.

    Time frame: Up to 16 months

    By completion of AUASI

  4. Urinary symptoms experienced on the American Urological Association Symptom Index

    Time frame: Up to 16 months

  5. Mean Urgency Perception Scores recorded on a 3 day bladder diary

    Time frame: Up to 16 months

  6. Patient Perception of Bladder Condition

    Time frame: Up to 16 months

  7. Severity of bowel symptoms

    Time frame: Up to 16 months

  8. Patient Perception of Bowel Condition

    Time frame: up to 16 months

  9. Changes in post-void residual urine volume.

    Time frame: Up to 16 months

  10. Amount of urine leakage in 24 hours

    Time frame: Up to 16 months

  11. 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.

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Collaborators

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

Registry information

Official study title

A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.

Acronym: TREAT-UI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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