Clinical Trials Logo
  1. Home
  2. Stress Urinary Incontinence
  3. NCT04143867

The Nolix Feasibility Efficacy and Safety Study

Stress Urinary Incontinence Clinical Trial

Official title:
A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women

Clinical Trial Summary

This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.

Clinical Trial Description

This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04143867
Study type Interventional
Source Gynamics LTD
Contact
Status Completed
Phase N/A
Start date January 1, 2019
Completion date March 31, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04829357 - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1