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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Nolix Device

• Registration Number: NCT04325477
• Lead Sponsor: Gynamics LTD

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-10-31
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-05
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Nolix Device	Nolix Device	Comparing use of device to non-treatment (pads only) phase

Primary Outcome Measures

Name	Time	Method
Continuous percent change in urine leakage	Pads were measured before and immediately after the 1 hour PWG test	Continuous percent change in urine leakage is defined as: 100%\*(PWG without Nolix - PWG with Nolix)/PWG without Nolix.
Dichotomous change in urine leakage	Pads were measured before and immediately after the 1 hour PWG	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%
Change in the dryness of the pad	Pads were measured before and immediately after the 1 hour PWG	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.

Secondary Outcome Measures

Name	Time	Method
Comfort during Nolix use	1 Day	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)
Overall satisfaction: Nolix Satisfaction Questionnaire	1 Day	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).

Trial Locations

Locations (1)

Assuta Medical Center; 🇮🇱 Haifa, Israel