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"

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Athena Pelvic Muscle Trainer

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 Type: Interventional
• Enrollment (Actual): 462
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • John Foster MD
    • Birmingham, Alabama, United States, 35211
      • La Mamma Spa
    • Dothan, Alabama, United States, 36305
      • Kyle Chavers MD
  • Arizona
    • Casa Grande, Arizona, United States, 85122
      • Salud! for Women
    • Chandler, Arizona, United States, 85226
      • New Horizons Women's Care
    • Peoria, Arizona, United States, 85381
      • Barbara Wiggin PhD, ANP-C
    • Phoenix, Arizona, United States, 85044
      • Agnes Oblas APRN
    • Scottsdale, Arizona, United States, 85251
      • Arcadia Well Woman
    • Tempe, Arizona, United States, 85283
      • Patricia A Faust
    • Tucson, Arizona, United States, 85704
      • Beth Andresen
    • Tucson, Arizona, United States, 85704
      • Teresa Mote RNC NP
  • California
    • El Dorado Hills, California, United States, 95726
      • Brenda Hanson-Smith, RN, DNS, OGNP
    • Ontario, California, United States, 91762
      • Lynda Reed
    • Rolling Hills Est., California, United States, 90274
      • Rose Mary Mosher
    • San Diego, California, United States, 92103
      • Evan Vapnek MD
    • San Jacinto, California, United States, 92583
      • Marilyn Brooks
    • San Luis Obispo, California, United States, 93405
      • Healthworks
  • Colorado
    • Northglenn, Colorado, United States, 80234
      • Maureen Allen
    • Parker, Colorado, United States, 80134
      • Kristan Langdon, ANP-C
    • Salida, Colorado, United States, 81201
      • Karen D. Adamson
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Merrilyn H. McNatt APRN
    • South Windsor, Connecticut, United States, 06074
      • Jean Ohliger APRN
  • Florida
    • Blountstown, Florida, United States, 32424
      • Arlena Falcon
    • Boynton Beach, Florida, United States, 33472
      • Carl Spirazza
    • Ft. Lauderdale, Florida, United States, 33316
      • Khadra Mohamoud Osman mD
    • Lake Worth, Florida, United States, 33461
      • Shelly E Kramer ARNP
    • Margate, Florida, United States, 33316
      • Ivonne M. Reynolds
    • Ormond Beach, Florida, United States, 32174
      • Susan Chappuis, ARNP-C
    • Stuart, Florida, United States, 34994
      • Elizabeth Tsarnas
    • Venice, Florida, United States, 34285
      • Bayside Gynecology, P.A.
    • West Palm Beach, Florida, United States, 33407
      • Jeffrey C Seiler, MD
  • Georgia
    • Albany, Georgia, United States, 31707
      • Deborah Cothran WHNP-BC
    • Fayetteville, Georgia, United States, 30214
      • Elizabeth Killebrew MD
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • Laurie Knoke
    • Deerfield, Illinois, United States, 60015
      • Michael D Benson
    • Gurnee, Illinois, United States, 60031
      • Sherry Owen, APN
    • Park Ridge, Illinois, United States, 60068
      • Julie Snow
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Kathryn A. Copeland
    • Fort Wayne, Indiana, United States, 46825
      • Matthew Sprunger MD
  • Kansas
    • Lakin, Kansas, United States, 67860
      • Tamara Meisel ARNP
  • Kentucky
    • Ashland, Kentucky, United States, 41105
      • Richard F. Ford MD
    • Lexington, Kentucky, United States, 40503
      • Women's Care Center
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Tammi K Herkey
    • Covington, Louisiana, United States, 70433
      • Stefanie A Schultis
  • Maryland
    • Bel Air, Maryland, United States, 21014
      • Steven Lenowitz, MD
    • Columbia, Maryland, United States, 21044
      • Kathryn Cervi
    • Galena, Maryland, United States, 21635
      • Elizabeth P Sipala
    • Prince Frederick, Maryland, United States, 20678
      • Deborah A. Davis, MSN, CRNP
  • Massachusetts
    • Gt. Barrington, Massachusetts, United States, 01230
      • Martha Klay
    • Springfield, Massachusetts, United States, 01107
      • Pioneer Valley Urology
    • Walpole, Massachusetts, United States, 02081
      • Margaret Duggan
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Kathryn Koches
    • Paw Paw, Michigan, United States, 49079
      • Women's Health Care Specialists, PC
    • Riverview, Michigan, United States, 48193
      • Isabel M Raposo
    • Saginaw, Michigan, United States, 48638
      • Laura Hintz
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Mickie G. Autry PhD, NP-C
  • Montana
    • Kalispell, Montana, United States, 59901
      • Kathleen M. Young RNC NP
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Urogynecology Arts of New Jersey
    • Galloway, New Jersey, United States, 08205
      • Lynda M. Adamson
    • Hamburg, New Jersey, United States, 07419
      • Women's Total Health
    • Vineland, New Jersey, United States, 08360
      • Cindy Nevara APN
  • New York
    • Albany, New York, United States, 12205
      • Jeanne Ann Dahl, RNC, WHNP
    • Cortland, New York, United States, 13045
      • Meredith Schledorn
    • Oswego, New York, United States, 13126
      • Raj Mahajan MD
    • W. Seneca, New York, United States, 14224
      • Diane Stonemetz
  • North Dakota
    • Minot, North Dakota, United States, 58703
      • Kathy Edwards
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Columbus OB/Gyn Inc.
    • Columbus, Ohio, United States, 43213
      • Holly Murphy
    • Columbus, Ohio, United States, 43222
      • Susan Frost
    • Fairfield, Ohio, United States, 45014
      • Amy G Brenner M.D
    • Gallipolis, Ohio, United States, 45631
      • Elizabeth D. Allen CNP
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • William Shuler, MD
  • Oregon
    • Bend, Oregon, United States, 97701
      • Deborah Malone
    • Eugene, Oregon, United States, 97401
      • Anne Marie Moore, Womens Health Nurse Practitioner
    • Portland, Oregon, United States, 97219
      • Cathleen Ann Folk FNP
    • Roseburg, Oregon, United States, 97470
      • Mary L Hagood, FNP-C
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Institute for Female Pelvic Medicine
    • St. Mary's, Pennsylvania, United States, 15857
      • Paulette Schreiber, CRNP
    • West Chester, Pennsylvania, United States, 19380
      • Marie T Ziegler
  • South Carolina
    • Lexington, South Carolina, United States, 29072
      • Nancy Newman RNC, WHNP
  • Tennessee
    • Collierville, Tennessee, United States, 38017
      • Sharon Little
    • Franklin, Tennessee, United States, 37067
      • Margaret A. Hull
    • Nashville, Tennessee, United States, 37209
      • Urology Associates, P.C.
  • Texas
    • Arlington, Texas, United States, 76014
      • John Pickel MD
    • Houston, Texas, United States, 77030
      • Christopher J. Jayne, MD, FACOG
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio
    • San Antonio, Texas, United States, 78232
      • Marney Kidwell RNC
    • Waco, Texas, United States, 76708
      • D. Crawford Allison MD
  • Utah
    • Lehi, Utah, United States, 84043
      • Laura C. Maw
  • Vermont
    • Bennington, Vermont, United States, 05201
      • Betsy Browning
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Anne L Stephens
    • Chesapeake, Virginia, United States, 23320
      • Rand Gynecology, LLC
    • Lansdowne, Virginia, United States, 20176
      • Julie Spencer
    • Newport News, Virginia, United States, 23602
      • Patrice C Malena
  • Washington
    • Ilwaco, Washington, United States, 98624
      • Ocean Beach Women's Clinic
    • Vashon, Washington, United States, 98070
      • Kimberly Scheer
• Virgin Islands (U.S.)
  • Christiansted, Virgin Islands (U.S.), 00820
    • Primary Care, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Athena Feminine Technologies, Inc.
• Investigators: Study Director: Julia Shaw, MD, Director of Women's Health, Yale University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 17, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 14, 2011
• Last Update Submitted That Met QC Criteria: July 13, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Urinary Stress Incontinence; Urinary Mixed Incontinence; Urinary Urge Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: PMT-4-001