Athena Pelvic Muscle Trainer - DUETS Trial (DUETS)
|ClinicalTrials.gov Identifier: NCT01073878|
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : July 14, 2011
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
- Over Active Bladder Questionnaire
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
- Female Sexual Function Index questionnaire
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Device: Athena Pelvic Muscle Trainer||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||462 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Device: Athena Pelvic Muscle Trainer
- Athena PMT
- Pelvic Muscle Trainer
- To assess objective treatment outcomes of urge, stress or mixed incontinence. [ Time Frame: 5 Visits over 13 weeks. Subjects are seen in the office at Screening Visit 1 (Week -1), Visit 1a (Week 0), Visit 2 (Week 2), Visit 3 (Week 6), Visit 4 (Week 12) ]Outcomes will be measured via patient questionnaires over a 13 week trial. Visit 1 (Week -1) and Visit 4 (Week 12) values for the Overactive Bladder Questionnaire and the Female Sexual Function Index will be captured. 7-day Urine Diaries will be captured for the week preceeding visits 2, 3 and 4.
- Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire [ Time Frame: At Visit 4 (Week 12) ]At the last visit, patients will complete a Subject Satisfaction Survey.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073878
Show 97 Study Locations
|Study Director:||Julia Shaw, MD||Director of Women's Health, Yale University|