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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
462
The Athena PMT is a vaginally inserted electrical stimulator that induces the pelvic floor muscles to contract and relax, similar to Kegel exercises intended to strengthen the pelvic floor muscles.
To assess objective treatment outcomes of urge, stress or mixed incontinence.
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.
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)
Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire
At the last visit, patients will complete a Subject Satisfaction Survey.
Time frame: At Visit 4 (Week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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