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
Who can participate
Age range30 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
To assess objective treatment outcomes of urge, stress or mixed incontinence.
Timeframe: 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)