A Feasibility Study With a Novel, Dynamic and Disposable Over-the-counter Device for Stress Urinary Incontinence

Study Overview
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Brief Summary
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This study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. Subjects served as their own control.

Detailed Description
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The primary objectives of this feasibility study were to evaluate the short-term efficacy of the Nolix device by measuring a reduction of SUI following a modified 1-hour PWG test and to measure the safety of the Nolix device based on adverse events that were reported by subjects during the study. The secondary objective was to assess usability and patient satisfaction using the Nolix device.

Official Title
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A Feasibility, Short-term Study With a Novel, Dynamic, and Disposable Over the Counter Device for Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Nolix Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females aged 21 and above Suffering from Stress Urinary Incontinence Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study Exclusion Criteria: Age ≤ 21 years Pregnant or planning to become pregnant during the study. Vaginal birth or Cesarean section for the last 3 months prior to entering the study. Severely atrophic vagina. A history of Toxic Shock Syndrome (TSS). Active urinary tract or vaginal infection. Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year). Has experienced unusual or unexpected vaginal bleeding within the last 6 months. Vaginal surgery within the last 3 months prior to entering the study. Has experienced difficulties with the use of intra-vaginal devices, including tampons. Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: A prospective one-arm study with subjects serving as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nolix Device<br>Comparing use of device to non-treatment (pads only) phase | Device: Nolix Device<br>* The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous percent change in urine leakage | Continuous percent change in urine leakage is defined as: 100%*(PWG without Nolix - PWG with Nolix)/PWG without Nolix. | Pads were measured before and immediately after the 1 hour PWG test | 
| Change in the dryness of the pad | Success (1) if following the 1-hour PWG test, the pad weight increases by no more than 1 gram or Failure (0) if following the 1-hour test, the pad weight increased by more than 1 gram. | Pads were measured before and immediately after the 1 hour PWG | 
| Dichotomous change in urine leakage | In accordance with FDA recommendations, the clinically meaningful level of improvement in PWG is at least 50%. Therefore, the dichotomous change is defined for each patient as follows: Success (1), if continuous percent change in PWG > 50% or Failure (0), if continuous percent change in PWG < 50% | Pads were measured before and immediately after the 1 hour PWG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort during Nolix use | Comfort during Nolix device use will be measured through the Satisfaction Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device). Comfort during Nolix device use will be measured through the Benefit, Satisfaction, and Willingness to Continue Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device) | 1 Day | 
| Overall satisfaction: Nolix Satisfaction Questionnaire | Overall Satisfaction with the use of the Nolix device, as measured using the Nolix Satisfaction Questionnaire, selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all' (where 'Completely' is the most positive response and 'Not at all' is the most negative response). | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravaginal device, pad weight gain, stress urinary incontinence