Athena Pelvic Muscle Trainer - DUETS Trial

Athena Feminine Technologies

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Device: Athena Pelvic Muscle Trainer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01073878

PMT-4-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 462 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women between the ages of 30 and 70 years
2. Suffer from urge-incontinence, stress incontinence or incontinence of mixed etiology and who may benefit from strengthening Kegel muscles by electrical stimulation
3. Able to provide informed consent and physically able to comply with protocol requirements.
4. Experience one or more incontinence episodes per week.
5. Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment.
6. 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.
7. Have a positive response to two or more questions on the Athena Questionnaire

Exclusion criteria

1. Neurological deficiency that does not permit proper sensory perception or stimulation.
2. Is currently pregnant, lactating or attempting to get pregnant
3. Has a cardiac pacemaker or a history of rate or conductive disturbance
4. Has anatomical vaginal structures that do not permit proper and complete placement of the trainer.
5. Has irregular menstrual bleeding cycles.
6. Has urinary or vaginal infections, localized lesions, or other undiagnosed symptoms.
7. Has a history or symptoms of urinary retention.
8. Has cancer or a life expectancy of less than one year
9. Recreational drug use
10. Consume more than three caffeine beverages daily
11. Consume more than 1-2 alcoholic drinks per day
12. Significant drug use (causing diuresis or urinary retention
13. Allergy or sensitivity to materials in the Athena PMT
14. Participation in another clinical trial within past 3 months
15. Subjects morbidly obese (BMI >35)
16. Subjects who chronically smoke (> 10 cigarettes per day)
17. Subjects required to do heavy lifting (> 40 pounds regularly)
18. Surgery within the past six months for incontinence, or use of other incontinence devices
19. 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.
20. Suspected infection or condition (e.g., diabetes) that would alter the subjects ability to participate or would confound the results of the trial