Athena Pelvic Muscle Trainer - DUETS Trial — DUETS  

Urinary Incontinence Clinical Trial

Official title: Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic floor muscles by collecting data from the patient on the

1. Over Active Bladder Questionnaire

2. The 7-Day Urine Diary questionnaire

This study will also look at whether or not there is an improvement in sexual health after using the device by collecting data frm the patient on the

3. Female Sexual Function Index questionnaire

Clinical Trial Description

This is a Phase IV, prospective, open-label, multi-center, observational study to assess the effectiveness of the Athena PMT to relieve or eliminate the symptoms of female urinary incontinence.

The study will enlist approximately 100 or more Nurse-Practitioners in Women's Health as the principle investigators from community-based primary care centers (OB-GYN, Internal Medicine, Family Practices or Women's Health Centers) who will enroll approximately 500 or more subjects who suffer from urge and/or stress urinary incontinence and who may benefit from strengthening of Kegel muscles of the pelvic floor. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Incontinence

• NCT number: NCT01073878
• Study type: Interventional
• Source: Athena Feminine Technologies, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: February 2010
• Completion date: June 2011