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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04325477
Study type Interventional
Source Gynamics LTD
Contact
Status Completed
Phase N/A
Start date October 31, 2017
Completion date October 30, 2018
View Details
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