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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Nolix Device

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Assuta Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gynamics LTD
• Investigators: Principal Investigator: Boris Friedman, Dr, Carmel Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: stress urinary incontinence; intravaginal device; pad weight gain
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: NLX-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No