Evaluation of a New Technology for the Treatment of Bladder Leakage in Women

Study Overview
=================
Brief Summary
-----------------
Evaluation of a new technology for the treatment of bladder leakage in women. The objective is to compare quality of life and other incontinence associated outcomes between women receiving routine General Practitioner (GP) prescribed care for urinary incontinence compared with those prescribed the electrical stimulation device.

Detailed Description
-----------------
This United Kingdom study will comprise a single blind, primary care, post-market evaluation of a novel neuromuscular electrical stimulation treatment for urinary incontinence . Women with GP determined urinary incontinence (urgency, stress or mixed) will be randomised into one of two groups (intervention or control). The control group will receive routine care via their GP practice. The intervention group will receive the electrical stimulation device. Treatment will last for 12 weeks with a Quality of Life (QoL) primary end point immediately post treatment with a second phase to explore the impact of a further 12 weeks maintenance programme in the intervention group compared to routine care. There will be a further two year follow-up assessment.

Official Title
-----------------
Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial

Conditions
-----------------
Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge

Intervention / Treatment
-----------------
* Device: Electrical stimulation
* Other: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Aged between 18 and 65 GP determined urinary incontinence Exclusion Criteria: Abnormal abdominal mass Clinical history of urinary retention problems Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia Pregnancy or given birth within the last three months Implanted pacemaker Recent pelvic surgery (within the last 12 months) Recent haemorrhage, haematoma and/or tissue damage to the vagina Undergoing any active therapy or review appointments for pelvic malignancy Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test) Manual dexterity insufficient to place the electrical stimulation device in the vagina Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson's Disease Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed Insufficient cognitive ability to provide informed consent and/or participate in the study Unwillingness to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical stimulation<br>Neuromuscular electrical stimulation treatment | Device: Electrical stimulation<br>* Electrical stimulation device<br>|
| Active Comparator: Treatment As Usual<br>Usual GP treatment | Other: Treatment as usual<br>* GP treatment as usual<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condition specific quality of life | The primary outcome measure is Quality of Life measured through self-completion of the short form version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI). The Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity, and impact on urinary incontinence in research and clinical practice across the world. Scoring & analysis: Question items include: frequency of urinary incontinence, amount of leakage and leak interference. The overall score is calculated from the sum of: Leak frequency (minimum 0, maximum 5) Leak amount (minimum 0, maximum 6) Leak interference (minimum 0, maximum 10) Overall score is therefore between 0-21 - the higher the score the worse the outcome | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function Index (FSFI) | Brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials. The individual domain scores and full scale (overall) score of the FSFI are derived by adding the scores of the individual items that comprise each domain and multiplying the sum by a domain factor. The six domain scores are added together to obtain the full-scale score. Within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. Desire: Minimum score 1 maximum 5 Arousal: Minimum score 0 maximum 5 Lubrication: Minimum score 0 maximum 5 Orgasm: Minimum score 0 maximum 5 Satisfaction: Minimum score 0 maximum 5 Pain: Minimum score 0 maximum 5 Score are multiplied by pre defined factors with a total range of between 2 and 36 where 36 is the most satisfied | 12 weeks | 
| Sexual dysfunction questionnaire | The International Urogynecological Association Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire to assess sexual function. To score the sub-scales of which there are six in sexually active women and four in women who are not sexually active, half of the items must be answered, imputation is not recommended, and either mean calculation or transformed sum methods are recommended. There is a detailed process for calculating total scores that runs to three pages that has been published and validated in the International Urogynaecology Journal 2013 | 12 weeks | 
| Patient Global Impression of Severity and of Improvement | A well-validated global assessment of improvement questionnaire for women with urinary stress incontinence Scoring and analysis: The severity part of the scale is a single question asking the patient to rate how their urinary tract condition is now on a scale of 1 = Normal to 4 = Severe. The improvement part of the scale is a single question asking the patient to rate how their urinary tract condition is now compared with how it was before they started the study on a scale of 1 = very much better to 7 = very much worse | 12 weeks | 
| 1-hour in-clinic provocative pad weight test | A standardised Food and Drug Administration recommended test A standardised one hour test protocol is adopted from the recommendations of the International Continence Society. Scoring and analysis: Volume of urine leaked over one hour calculated from the difference in pad weight pre and post 1-hour activities. In terms of reporting the severity of urine loss is considered cured (<2g / hour), mild (2-10g / hour), moderate (11-50g/hour) and severe >50g/hour). | 12 weeks | 
| User experience Diaries | A diary that records user experience will be completed every two weeks over the 12 weeks of the study. A second diary that records usability specific to treatment arm will be completed every other day in the first four weeks of the study and then every week for the following eight weeks. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuromuscular electrical stimulation, incontinence