Athena Pelvic Muscle Trainer - DUETS Trial
DUETS
Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"
1 other identifier
interventional
462
2 countries
97
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
- 3.Female Sexual Function Index questionnaire
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2010
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 14, 2011
July 1, 2011
1.3 years
February 17, 2010
July 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
John Foster MD
Birmingham, Alabama, 35205, United States
La Mamma Spa
Birmingham, Alabama, 35211, United States
Kyle Chavers MD
Dothan, Alabama, 36305, United States
Salud! for Women
Casa Grande, Arizona, 85122, United States
New Horizons Women's Care
Chandler, Arizona, 85226, United States
Barbara Wiggin PhD, ANP-C
Peoria, Arizona, 85381, United States
Agnes Oblas APRN
Phoenix, Arizona, 85044, United States
Arcadia Well Woman
Scottsdale, Arizona, 85251, United States
Patricia A Faust
Tempe, Arizona, 85283, United States
Beth Andresen
Tucson, Arizona, 85704, United States
Teresa Mote RNC NP
Tucson, Arizona, 85704, United States
Brenda Hanson-Smith, RN, DNS, OGNP
El Dorado Hills, California, 95726, United States
Lynda Reed
Ontario, California, 91762, United States
Rose Mary Mosher
Rolling Hills Est., California, 90274, United States
Evan Vapnek MD
San Diego, California, 92103, United States
Marilyn Brooks
San Jacinto, California, 92583, United States
Healthworks
San Luis Obispo, California, 93405, United States
Maureen Allen
Northglenn, Colorado, 80234, United States
Kristan Langdon, ANP-C
Parker, Colorado, 80134, United States
Karen D. Adamson
Salida, Colorado, 81201, United States
Merrilyn H. McNatt APRN
New London, Connecticut, 06320, United States
Jean Ohliger APRN
South Windsor, Connecticut, 06074, United States
Arlena Falcon
Blountstown, Florida, 32424, United States
Carl Spirazza
Boynton Beach, Florida, 33472, United States
Khadra Mohamoud Osman mD
Fort Lauderdale, Florida, 33316, United States
Shelly E Kramer ARNP
Lake Worth, Florida, 33461, United States
Ivonne M. Reynolds
Margate, Florida, 33316, United States
Susan Chappuis, ARNP-C
Ormond Beach, Florida, 32174, United States
Elizabeth Tsarnas
Stuart, Florida, 34994, United States
Bayside Gynecology, P.A.
Venice, Florida, 34285, United States
Jeffrey C Seiler, MD
West Palm Beach, Florida, 33407, United States
Deborah Cothran WHNP-BC
Albany, Georgia, 31707, United States
Elizabeth Killebrew MD
Fayetteville, Georgia, 30214, United States
Michael D Benson
Deerfield, Illinois, 60015, United States
Laurie Knoke
DeKalb, Illinois, 60115, United States
Sherry Owen, APN
Gurnee, Illinois, 60031, United States
Julie Snow
Park Ridge, Illinois, 60068, United States
Kathryn A. Copeland
Carmel, Indiana, 46032, United States
Matthew Sprunger MD
Fort Wayne, Indiana, 46825, United States
Tamara Meisel ARNP
Lakin, Kansas, 67860, United States
Richard F. Ford MD
Ashland, Kentucky, 41105, United States
Women's Care Center
Lexington, Kentucky, 40503, United States
Tammi K Herkey
Bossier City, Louisiana, 71111, United States
Stefanie A Schultis
Covington, Louisiana, 70433, United States
Steven Lenowitz, MD
Bel Air, Maryland, 21014, United States
Kathryn Cervi
Columbia, Maryland, 21044, United States
Elizabeth P Sipala
Galena, Maryland, 21635, United States
Deborah A. Davis, MSN, CRNP
Prince Frederick, Maryland, 20678, United States
Martha Klay
Great Barrington, Massachusetts, 01230, United States
Pioneer Valley Urology
Springfield, Massachusetts, 01107, United States
Margaret Duggan
Walpole, Massachusetts, 02081, United States
Kathryn Koches
Dearborn, Michigan, 48124, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079, United States
Isabel M Raposo
Riverview, Michigan, 48193, United States
Laura Hintz
Saginaw, Michigan, 48638, United States
Mickie G. Autry PhD, NP-C
Jackson, Mississippi, 39202, United States
Kathleen M. Young RNC NP
Kalispell, Montana, 59901, United States
Urogynecology Arts of New Jersey
East Brunswick, New Jersey, 08816, United States
Lynda M. Adamson
Galloway, New Jersey, 08205, United States
Women's Total Health
Hamburg, New Jersey, 07419, United States
Cindy Nevara APN
Vineland, New Jersey, 08360, United States
Jeanne Ann Dahl, RNC, WHNP
Albany, New York, 12205, United States
Meredith Schledorn
Cortland, New York, 13045, United States
Raj Mahajan MD
Oswego, New York, 13126, United States
Diane Stonemetz
West Seneca, New York, 14224, United States
Kathy Edwards
Minot, North Dakota, 58703, United States
Columbus OB/Gyn Inc.
Columbus, Ohio, 43213, United States
Holly Murphy
Columbus, Ohio, 43213, United States
Susan Frost
Columbus, Ohio, 43222, United States
Amy G Brenner M.D
Fairfield, Ohio, 45014, United States
Elizabeth D. Allen CNP
Gallipolis, Ohio, 45631, United States
William Shuler, MD
Tulsa, Oklahoma, 74133, United States
Deborah Malone
Bend, Oregon, 97701, United States
Anne Marie Moore, Womens Health Nurse Practitioner
Eugene, Oregon, 97401, United States
Cathleen Ann Folk FNP
Portland, Oregon, 97219, United States
Mary L Hagood, FNP-C
Roseburg, Oregon, 97470, United States
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, 18103, United States
Paulette Schreiber, CRNP
Saint Mary's, Pennsylvania, 15857, United States
Marie T Ziegler
West Chester, Pennsylvania, 19380, United States
Nancy Newman RNC, WHNP
Lexington, South Carolina, 29072, United States
Sharon Little
Collierville, Tennessee, 38017, United States
Margaret A. Hull
Franklin, Tennessee, 37067, United States
Urology Associates, P.C.
Nashville, Tennessee, 37209, United States
John Pickel MD
Arlington, Texas, 76014, United States
Christopher J. Jayne, MD, FACOG
Houston, Texas, 77030, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Marney Kidwell RNC
San Antonio, Texas, 78232, United States
D. Crawford Allison MD
Waco, Texas, 76708, United States
Laura C. Maw
Lehi, Utah, 84043, United States
Betsy Browning
Bennington, Vermont, 05201, United States
Anne L Stephens
Chesapeake, Virginia, 23320, United States
Rand Gynecology, LLC
Chesapeake, Virginia, 23320, United States
Julie Spencer
Lansdowne, Virginia, 20176, United States
Patrice C Malena
Newport News, Virginia, 23602, United States
Ocean Beach Women's Clinic
Ilwaco, Washington, 98624, United States
Kimberly Scheer
Vashon, Washington, 98070, United States
Primary Care, PLLC
Christiansted, VI, 00820, Virgin Islands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Julia Shaw, MD
Director of Women's Health, Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 23, 2010
Study Start
February 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 14, 2011
Record last verified: 2011-07