An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence

Study Overview
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Brief Summary
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This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.

Official Title
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An Open Randomized Controlled Multicenter Clinical Investigation With an Intra-vaginal Device for Stress Urinary Incontinence in Comparison to Using Standard of Care

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: TVS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Over the age of 18 years Women diagnosed with stress urinary incontinence Normal voiding without residual urine ≤100mL Leakage of at least 10 grams per 24 hours (based on pad-weight test) Provoking test with leakage Exclusion Criteria: History of dominated urgency's symptoms Any contraindication for the investigational device; such as hypersensitivity to silicon rubber Unexplained pelvic bleeding or vaginal discharge Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction. The woman is currently using prolapse ring Women with prolapse reaching the hymus during coughing. Pregnant or suspicion of pregnancy Urinary tract or vaginal infection History of not being able to use tampons Neurogenic bladder dysfunction The patient is to start, or change an ongoing, pelvic floor training If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment The patient is participating in another study on SUI Any other condition that as judged by the investigator may make follow-up or investigations inappropriate Any patient that according to the Declaration of Helsinki is unsuitable for enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans Vagina Support<br>Tension Free Vaginal Support (TVS):The subjects in the TVS Group used pads during week 1 (Baseline), fitted, trained and selected device size week 2 and used the selected device size during week 3 (treatment week). | Device: TVS<br>* Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.<br>|
| No Intervention: Standard Care<br>Standard of care (SoC): The subjects in the SoC group continued with conventional treatment i.e. using pads during week 1, 2 and 3. They were offered to use the TVS device for two weeks after completion of week 3. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute reduction in leakage as measured by pad weight in gram | The primary endpoint will be the absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in % in reducing urinary leakage measured by pad weight | Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3). | 3 weeks | 
| Reduction of urinary leakage episodes measured by subjective observations | Reduction of SUI episodes from the run-in week compared to the final week (week 3) by entry of subjective observations in study diary. | 3 weeks | 
| General impact on quality of life parameters | General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3. | 3 weeks | 
| Impact on disease specific qulity of life parameters | Disease specific Impact of Quality of life parameters, measured by the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) comparing week 1 and week. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal, Medical Device, Female Stress Urinary Incontinence