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

Sponsor

Gynamics LTD (Industry)

Overall Status

Completed

CT.gov ID

NCT04325477

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Nolix Device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Intervention Model:

Sequential Assignment

Intervention Model Description:

A prospective one-arm study with subjects serving as their own control.A prospective one-arm study with subjects serving as their own control.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 31, 2017

Actual Primary Completion Date :

Oct 30, 2018

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Nolix Device

Comparing use of device to non-treatment (pads only) phase

Device: Nolix Device

The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI

Outcome Measures

Primary Outcome Measures

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.
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.
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%

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.