Athena Pelvic Muscle Trainer - DUETS Trial

Phase 4

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT01073878
• Lead Sponsor: Athena Feminine Technologies, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 462

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess objective treatment outcomes of urge, stress or mixed incontinence.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire	At Visit 4 (Week 12)	At the last visit, patients will complete a Subject Satisfaction Survey.

Trial Locations

Locations (97)

John Foster MD; 🇺🇸 Birmingham, Alabama, United States

La Mamma Spa; 🇺🇸 Birmingham, Alabama, United States

Kyle Chavers MD; 🇺🇸 Dothan, Alabama, United States

Salud! for Women; 🇺🇸 Casa Grande, Arizona, United States

New Horizons Women's Care; 🇺🇸 Chandler, Arizona, United States

Barbara Wiggin PhD, ANP-C; 🇺🇸 Peoria, Arizona, United States

Agnes Oblas APRN; 🇺🇸 Phoenix, Arizona, United States

Arcadia Well Woman; 🇺🇸 Scottsdale, Arizona, United States

Patricia A Faust; 🇺🇸 Tempe, Arizona, United States

Beth Andresen; 🇺🇸 Tucson, Arizona, United States

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