Athena Pelvic Muscle Trainer - DUETS Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Athena Pelvic Muscle Trainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the ages of 30 and 70 years Suffer from urge-incontinence, stress incontinence or incontinence of mixed etiology and who may benefit from strengthening Kegel muscles by electrical stimulation Able to provide informed consent and physically able to comply with protocol requirements. Experience one or more incontinence episodes per week. Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment. Subject may be post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra- uterine device (IUD), diaphragm with spermicide, condom with spermicide or abstinence) from the screening visit through the duration of study participation. Have a positive response to two or more questions on the Athena Questionnaire Exclusion Criteria: Neurological deficiency that does not permit proper sensory perception or stimulation. Is currently pregnant, lactating or attempting to get pregnant Has a cardiac pacemaker or a history of rate or conductive disturbance Has anatomical vaginal structures that do not permit proper and complete placement of the trainer. Has irregular menstrual bleeding cycles. Has urinary or vaginal infections, localized lesions, or other undiagnosed symptoms. Has a history or symptoms of urinary retention. Has cancer or a life expectancy of less than one year Recreational drug use Consume more than three caffeine beverages daily Consume more than 1-2 alcoholic drinks per day Significant drug use (causing diuresis or urinary retention Allergy or sensitivity to materials in the Athena PMT Participation in another clinical trial within past 3 months Subjects morbidly obese (BMI >35) Subjects who chronically smoke (> 10 cigarettes per day) Subjects required to do heavy lifting (> 40 pounds regularly) Surgery within the past six months for incontinence, or use of other incontinence devices Currently taking cholinergic or anti-cholinergic drugs or other prescription or non-prescription drugs that may increase or decrease the volume or frequency of urination and thus, may confound the results of this study, except, in the opinion of the investigator. The subject's regimen has been stable for at least sixty days. Suspected infection or condition (e.g., diabetes) that would alter the subjects ability to participate or would confound the results of the trial

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Athena Pelvic Muscle Trainer|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Visit 4 (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Urge Incontinence, Urinary Stress Incontinence, Urinary Mixed Incontinence