NCT04143867

The Nolix Feasibility Efficacy and Safety Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Gynamics LTD · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Nolix Device	For temporary management of SUI

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-10-29
• Last updated: 2021-08-16

Locations

1 site across 1 country: Israel