Athena Pelvic Muscle Trainer - DUETS Trial
| Status: | Archived |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | December 2010 |
Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"
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
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.
We found this trial at
96
sites
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Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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