Clinical trial NCT01073878: Athena Pelvic Muscle Trainer - DUETS Trial
Official title: Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: Urinary Urge Incontinence
Urinary Stress Incontinence
Urinary Mixed Incontinence
Lead sponsor: Athena Feminine Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 462
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess objective treatment outcomes of urge, stress or mixed incontinence.
timeFrame: 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:
measure: Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire
timeFrame: At Visit 4 (Week 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: John Foster MD
state: Alabama
city: Birmingham
country: United States
facility: La Mamma Spa
state: Alabama
city: Dothan
country: United States
facility: Kyle Chavers MD
state: Alabama
city: Casa Grande
country: United States
facility: Salud! for Women
state: Arizona
city: Chandler
country: United States
facility: New Horizons Women's Care
state: Arizona
city: Peoria
country: United States
facility: Barbara Wiggin PhD, ANP-C
state: Arizona
city: Phoenix
country: United States
facility: Agnes Oblas APRN
state: Arizona
city: Scottsdale
country: United States
facility: Arcadia Well Woman
state: Arizona
city: Tempe
country: United States
facility: Patricia A Faust
state: Arizona
city: Tucson
country: United States
facility: Beth Andresen
state: Arizona
city: Tucson
country: United States
facility: Teresa Mote RNC NP
state: Arizona
city: El Dorado Hills
country: United States
facility: Brenda Hanson-Smith, RN, DNS, OGNP
state: California
city: Ontario
country: United States
facility: Lynda Reed
state: California
city: Rolling Hills Est.
country: United States
facility: Rose Mary Mosher
state: California
city: San Diego
country: United States
facility: Evan Vapnek MD
state: California
city: San Jacinto
country: United States
facility: Marilyn Brooks
state: California
city: San Luis Obispo
country: United States
facility: Healthworks
state: California
city: Northglenn
country: United States
facility: Maureen Allen
state: Colorado
city: Parker
country: United States
facility: Kristan Langdon, ANP-C
state: Colorado
city: Salida
country: United States
facility: Karen D. Adamson
state: Colorado
city: New London
country: United States
facility: Merrilyn H. McNatt APRN
state: Connecticut
city: South Windsor
country: United States
facility: Jean Ohliger APRN
state: Connecticut
city: Blountstown
country: United States
facility: Arlena Falcon
state: Florida
city: Boynton Beach
country: United States
facility: Carl Spirazza
state: Florida
city: Ft. Lauderdale
country: United States
facility: Khadra Mohamoud Osman mD
state: Florida
city: Lake Worth
country: United States
facility: Shelly E Kramer ARNP
state: Florida
city: Margate
country: United States
facility: Ivonne M. Reynolds
state: Florida
city: Ormond Beach
country: United States
facility: Susan Chappuis, ARNP-C
state: Florida
city: Stuart
country: United States
facility: Elizabeth Tsarnas
state: Florida
city: Venice
country: United States
facility: Bayside Gynecology, P.A.
state: Florida
city: West Palm Beach
country: United States
facility: Jeffrey C Seiler, MD
state: Florida
city: Albany
country: United States
facility: Deborah Cothran WHNP-BC
state: Georgia
city: Fayetteville
country: United States
facility: Elizabeth Killebrew MD
state: Georgia
city: Deerfield
country: United States
facility: Michael D Benson
state: Illinois
city: DeKalb
country: United States
facility: Laurie Knoke
state: Illinois
city: Gurnee
country: United States
facility: Sherry Owen, APN
state: Illinois
city: Park Ridge
country: United States
facility: Julie Snow
state: Illinois
city: Carmel
country: United States
facility: Kathryn A. Copeland
state: Indiana
city: Fort Wayne
country: United States
facility: Matthew Sprunger MD
state: Indiana
city: Lakin
country: United States
facility: Tamara Meisel ARNP
state: Kansas
city: Ashland
country: United States
facility: Richard F. Ford MD
state: Kentucky
city: Lexington
country: United States
facility: Women's Care Center
state: Kentucky
city: Bossier City
country: United States
facility: Tammi K Herkey
state: Louisiana
city: Covington
country: United States
facility: Stefanie A Schultis
state: Louisiana
city: Bel Air
country: United States
facility: Steven Lenowitz, MD
state: Maryland
city: Columbia
country: United States
facility: Kathryn Cervi
state: Maryland
city: Galena
country: United States
facility: Elizabeth P Sipala
state: Maryland
city: Prince Frederick
country: United States
facility: Deborah A. Davis, MSN, CRNP
state: Maryland
city: Gt. Barrington
country: United States
facility: Martha Klay
state: Massachusetts
city: Springfield
country: United States
facility: Pioneer Valley Urology
state: Massachusetts
city: Walpole
country: United States
facility: Margaret Duggan
state: Massachusetts
city: Dearborn
country: United States
facility: Kathryn Koches
state: Michigan
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
state: Michigan
city: Riverview
country: United States
facility: Isabel M Raposo
state: Michigan
city: Saginaw
country: United States
facility: Laura Hintz
state: Michigan
city: Jackson
country: United States
facility: Mickie G. Autry PhD, NP-C
state: Mississippi
city: Kalispell
country: United States
facility: Kathleen M. Young RNC NP
state: Montana
city: East Brunswick
country: United States
facility: Urogynecology Arts of New Jersey
state: New Jersey
city: Galloway
country: United States
facility: Lynda M. Adamson
state: New Jersey
city: Hamburg
country: United States
facility: Women's Total Health
state: New Jersey
city: Vineland
country: United States
facility: Cindy Nevara APN
state: New Jersey
city: Albany
country: United States
facility: Jeanne Ann Dahl, RNC, WHNP
state: New York
city: Cortland
country: United States
facility: Meredith Schledorn
state: New York
city: Oswego
country: United States
facility: Raj Mahajan MD
state: New York
city: W. Seneca
country: United States
facility: Diane Stonemetz
state: New York
city: Minot
country: United States
facility: Kathy Edwards
state: North Dakota
city: Columbus
country: United States
facility: Columbus OB/Gyn Inc.
state: Ohio
city: Columbus
country: United States
facility: Holly Murphy
state: Ohio
city: Columbus
country: United States
facility: Susan Frost
state: Ohio
city: Fairfield
country: United States
facility: Amy G Brenner M.D
state: Ohio
city: Gallipolis
country: United States
facility: Elizabeth D. Allen CNP
state: Ohio
city: Tulsa
country: United States
facility: William Shuler, MD
state: Oklahoma
city: Bend
country: United States
facility: Deborah Malone
state: Oregon
city: Eugene
country: United States
facility: Anne Marie Moore, Womens Health Nurse Practitioner
state: Oregon
city: Portland
country: United States
facility: Cathleen Ann Folk FNP
state: Oregon
city: Roseburg
country: United States
facility: Mary L Hagood, FNP-C
state: Oregon
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: St. Mary's
country: United States
facility: Paulette Schreiber, CRNP
state: Pennsylvania
city: West Chester
country: United States
facility: Marie T Ziegler
state: Pennsylvania
city: Lexington
country: United States
facility: Nancy Newman RNC, WHNP
state: South Carolina
city: Collierville
country: United States
facility: Sharon Little
state: Tennessee
city: Franklin
country: United States
facility: Margaret A. Hull
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Arlington
country: United States
facility: John Pickel MD
state: Texas
city: Houston
country: United States
facility: Christopher J. Jayne, MD, FACOG
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: San Antonio
country: United States
facility: Marney Kidwell RNC
state: Texas
city: Waco
country: United States
facility: D. Crawford Allison MD
state: Texas
city: Lehi
country: United States
facility: Laura C. Maw
state: Utah
city: Bennington
country: United States
facility: Betsy Browning
state: Vermont
city: Chesapeake
country: United States
facility: Anne L Stephens
state: Virginia
city: Chesapeake
country: United States
facility: Rand Gynecology, LLC
state: Virginia
city: Lansdowne
country: United States
facility: Julie Spencer
state: Virginia
city: Newport News
country: United States
facility: Patrice C Malena
state: Virginia
city: Ilwaco
country: United States
facility: Ocean Beach Women's Clinic
state: Washington
city: Vashon
country: United States
facility: Kimberly Scheer
state: Washington
city: Christiansted
country: Virgin Islands (U.S.)
facility: Primary Care, PLLC
Study officials:
affiliation: Director of Women's Health, Yale University
name: Julia Shaw, MD
role: STUDY_DIRECTOR
References: