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

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Nolix Device

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring intravaginal device, pad weight gain, stress urinary incontinence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Assuta Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nolix Device

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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%

Secondary Outcome Measures

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)

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).

Full Information

NCT ID

NCT04325477

First Posted

March 20, 2020

Last Updated

April 5, 2020

Sponsor

Gynamics LTD

1. Study Identification

Unique Protocol Identification Number

NCT04325477

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

October 31, 2017 (Actual)

Primary Completion Date

October 30, 2018 (Actual)

Study Completion Date

October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gynamics LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

intravaginal device, pad weight gain, stress urinary incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nolix Device

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Nolix Device

Intervention Description

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

Primary Outcome Measure Information:

Title

Continuous percent change in urine leakage

Description

Continuous percent change in urine leakage is defined as: 100%*(PWG without Nolix - PWG with Nolix)/PWG without Nolix.

Time Frame

Pads were measured before and immediately after the 1 hour PWG test

Title

Change in the dryness of the pad

Description

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.

Time Frame

Pads were measured before and immediately after the 1 hour PWG

Title

Dichotomous change in urine leakage

Description

Time Frame

Pads were measured before and immediately after the 1 hour PWG

Secondary Outcome Measure Information:

Title

Comfort during Nolix use

Description

Time Frame

1 Day

Title

Overall satisfaction: Nolix Satisfaction Questionnaire

Description

Time Frame

1 Day

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris Friedman, Dr

Organizational Affiliation

Carmel Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assuta Medical Center

City

Haifa

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

All personal data gathered in this trial will be treated in the strictest confidence by investigators, monitors, sponsor's personnel and independent ethics committee

Citations:

PubMed Identifier

23797972

Citation

Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.

Results Reference

background

PubMed Identifier

33348425

Citation

Naor MS, Kaploun A, Friedman B. A feasibility study with a novel, dynamic, and disposable over-the-counter device for the management of stress urinary incontinence. Neurourol Urodyn. 2021 Feb;40(2):653-658. doi: 10.1002/nau.24598. Epub 2020 Dec 21.

Results Reference

derived

Links:

URL

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-investigations-devices-indicated-treatment-urinary-incontinence-guidance-industry-and-fda

Description

Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

Learn more about this trial

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

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