Athena Pelvic Muscle Trainer - DUETS Trial

Urinary Incontinence Clinical Trial

— DUETS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073878
• Other study ID #: PMT-4-001
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2010
• Last updated: July 13, 2011
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Athena Feminine Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
United States	Deborah Cothran WHNP-BC	Albany	Georgia
United States	Jeanne Ann Dahl, RNC, WHNP	Albany	New York
United States	Institute for Female Pelvic Medicine	Allentown	Pennsylvania
United States	John Pickel MD	Arlington	Texas
United States	Richard F. Ford MD	Ashland	Kentucky
United States	Steven Lenowitz, MD	Bel Air	Maryland
United States	Deborah Malone	Bend	Oregon
United States	Betsy Browning	Bennington	Vermont
United States	John Foster MD	Birmingham	Alabama
United States	La Mamma Spa	Birmingham	Alabama
United States	Arlena Falcon	Blountstown	Florida
United States	Tammi K Herkey	Bossier City	Louisiana
United States	Carl Spirazza	Boynton Beach	Florida
United States	Kathryn A. Copeland	Carmel	Indiana
United States	Salud! for Women	Casa Grande	Arizona
United States	New Horizons Women's Care	Chandler	Arizona
United States	Anne L Stephens	Chesapeake	Virginia
United States	Rand Gynecology, LLC	Chesapeake	Virginia
United States	Sharon Little	Collierville	Tennessee
United States	Kathryn Cervi	Columbia	Maryland
United States	Columbus OB/Gyn Inc.	Columbus	Ohio
United States	Holly Murphy	Columbus	Ohio
United States	Susan Frost	Columbus	Ohio
United States	Meredith Schledorn	Cortland	New York
United States	Stefanie A Schultis	Covington	Louisiana
United States	Kathryn Koches	Dearborn	Michigan
United States	Michael D Benson	Deerfield	Illinois
United States	Laurie Knoke	DeKalb	Illinois
United States	Kyle Chavers MD	Dothan	Alabama
United States	Urogynecology Arts of New Jersey	East Brunswick	New Jersey
United States	Brenda Hanson-Smith, RN, DNS, OGNP	El Dorado Hills	California
United States	Anne Marie Moore, Womens Health Nurse Practitioner	Eugene	Oregon
United States	Amy G Brenner M.D	Fairfield	Ohio
United States	Elizabeth Killebrew MD	Fayetteville	Georgia
United States	Matthew Sprunger MD	Fort Wayne	Indiana
United States	Margaret A. Hull	Franklin	Tennessee
United States	Khadra Mohamoud Osman mD	Ft. Lauderdale	Florida
United States	Elizabeth P Sipala	Galena	Maryland
United States	Elizabeth D. Allen CNP	Gallipolis	Ohio
United States	Lynda M. Adamson	Galloway	New Jersey
United States	Martha Klay	Gt. Barrington	Massachusetts
United States	Sherry Owen, APN	Gurnee	Illinois
United States	Women's Total Health	Hamburg	New Jersey
United States	Christopher J. Jayne, MD, FACOG	Houston	Texas
United States	Ocean Beach Women's Clinic	Ilwaco	Washington
United States	Mickie G. Autry PhD, NP-C	Jackson	Mississippi
United States	Kathleen M. Young RNC NP	Kalispell	Montana
United States	Shelly E Kramer ARNP	Lake Worth	Florida
United States	Tamara Meisel ARNP	Lakin	Kansas
United States	Julie Spencer	Lansdowne	Virginia
United States	Laura C. Maw	Lehi	Utah
United States	Nancy Newman RNC, WHNP	Lexington	South Carolina
United States	Women's Care Center	Lexington	Kentucky
United States	Ivonne M. Reynolds	Margate	Florida
United States	Kathy Edwards	Minot	North Dakota
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	Merrilyn H. McNatt APRN	New London	Connecticut
United States	Patrice C Malena	Newport News	Virginia
United States	Maureen Allen	Northglenn	Colorado
United States	Lynda Reed	Ontario	California
United States	Susan Chappuis, ARNP-C	Ormond Beach	Florida
United States	Raj Mahajan MD	Oswego	New York
United States	Julie Snow	Park Ridge	Illinois
United States	Kristan Langdon, ANP-C	Parker	Colorado
United States	Women's Health Care Specialists, PC	Paw Paw	Michigan
United States	Barbara Wiggin PhD, ANP-C	Peoria	Arizona
United States	Agnes Oblas APRN	Phoenix	Arizona
United States	Cathleen Ann Folk FNP	Portland	Oregon
United States	Deborah A. Davis, MSN, CRNP	Prince Frederick	Maryland
United States	Isabel M Raposo	Riverview	Michigan
United States	Rose Mary Mosher	Rolling Hills Est.	California
United States	Mary L Hagood, FNP-C	Roseburg	Oregon
United States	Laura Hintz	Saginaw	Michigan
United States	Karen D. Adamson	Salida	Colorado
United States	Marney Kidwell RNC	San Antonio	Texas
United States	Urology San Antonio	San Antonio	Texas
United States	Evan Vapnek MD	San Diego	California
United States	Marilyn Brooks	San Jacinto	California
United States	Healthworks	San Luis Obispo	California
United States	Arcadia Well Woman	Scottsdale	Arizona
United States	Jean Ohliger APRN	South Windsor	Connecticut
United States	Pioneer Valley Urology	Springfield	Massachusetts
United States	Paulette Schreiber, CRNP	St. Mary's	Pennsylvania
United States	Elizabeth Tsarnas	Stuart	Florida
United States	Patricia A Faust	Tempe	Arizona
United States	Beth Andresen	Tucson	Arizona
United States	Teresa Mote RNC NP	Tucson	Arizona
United States	William Shuler, MD	Tulsa	Oklahoma
United States	Kimberly Scheer	Vashon	Washington
United States	Bayside Gynecology, P.A.	Venice	Florida
United States	Cindy Nevara APN	Vineland	New Jersey
United States	Diane Stonemetz	W. Seneca	New York
United States	D. Crawford Allison MD	Waco	Texas
United States	Margaret Duggan	Walpole	Massachusetts
United States	Marie T Ziegler	West Chester	Pennsylvania
United States	Jeffrey C Seiler, MD	West Palm Beach	Florida
Virgin Islands (U.S.)	Primary Care, PLLC	Christiansted

Sponsors (1)

Lead Sponsor	Collaborator
Athena Feminine Technologies, Inc.

Countries where clinical trial is conducted

United States,  Virgin Islands (U.S.), 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No