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Completed

NCT Number: NCT04325477

A Feasibility 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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nolix Device

Device

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

Primary outcomes

  1. Continuous percent change in urine leakage

    Time frame: 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.

  2. Change in the dryness of the pad

    Time frame: 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.

  3. Dichotomous change in urine leakage

    Time frame: 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 outcomes

  1. Comfort during Nolix use

    Time frame: 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)

  2. Overall satisfaction: Nolix Satisfaction Questionnaire

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Gynamics LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2020
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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