Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
462 participants
INTERVENTIONAL
2010-02-28
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination Treatment With BTL-899 and HPM-6000UF Devices II
NCT05713864
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
NCT03969368
Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
NCT05624645
Combination Treatment With BTL-899 and HPM-6000UF Devices
NCT05537181
Synchronous and Asynchronous Telerehabilitation for Women With Urinary Incontinence
NCT06848517
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
30 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Athena Feminine Technologies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Athena FT
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julia Shaw, MD
Role: STUDY_DIRECTOR
Director of Women's Health, Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Teresa Mote RNC NP
Tucson, Arizona, United States
Brenda Hanson-Smith, RN, DNS, OGNP
El Dorado Hills, California, United States
Lynda Reed
Ontario, California, United States
Rose Mary Mosher
Rolling Hills Est., California, United States
Evan Vapnek MD
San Diego, California, United States
Marilyn Brooks
San Jacinto, California, United States
Healthworks
San Luis Obispo, California, United States
Maureen Allen
Northglenn, Colorado, United States
Kristan Langdon, ANP-C
Parker, Colorado, United States
Karen D. Adamson
Salida, Colorado, United States
Merrilyn H. McNatt APRN
New London, Connecticut, United States
Jean Ohliger APRN
South Windsor, Connecticut, United States
Arlena Falcon
Blountstown, Florida, United States
Carl Spirazza
Boynton Beach, Florida, United States
Khadra Mohamoud Osman mD
Fort Lauderdale, Florida, United States
Shelly E Kramer ARNP
Lake Worth, Florida, United States
Ivonne M. Reynolds
Margate, Florida, United States
Susan Chappuis, ARNP-C
Ormond Beach, Florida, United States
Elizabeth Tsarnas
Stuart, Florida, United States
Bayside Gynecology, P.A.
Venice, Florida, United States
Jeffrey C Seiler, MD
West Palm Beach, Florida, United States
Deborah Cothran WHNP-BC
Albany, Georgia, United States
Elizabeth Killebrew MD
Fayetteville, Georgia, United States
Michael D Benson
Deerfield, Illinois, United States
Laurie Knoke
DeKalb, Illinois, United States
Sherry Owen, APN
Gurnee, Illinois, United States
Julie Snow
Park Ridge, Illinois, United States
Kathryn A. Copeland
Carmel, Indiana, United States
Matthew Sprunger MD
Fort Wayne, Indiana, United States
Tamara Meisel ARNP
Lakin, Kansas, United States
Richard F. Ford MD
Ashland, Kentucky, United States
Women's Care Center
Lexington, Kentucky, United States
Tammi K Herkey
Bossier City, Louisiana, United States
Stefanie A Schultis
Covington, Louisiana, United States
Steven Lenowitz, MD
Bel Air, Maryland, United States
Kathryn Cervi
Columbia, Maryland, United States
Elizabeth P Sipala
Galena, Maryland, United States
Deborah A. Davis, MSN, CRNP
Prince Frederick, Maryland, United States
Martha Klay
Great Barrington, Massachusetts, United States
Pioneer Valley Urology
Springfield, Massachusetts, United States
Margaret Duggan
Walpole, Massachusetts, United States
Kathryn Koches
Dearborn, Michigan, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, United States
Isabel M Raposo
Riverview, Michigan, United States
Laura Hintz
Saginaw, Michigan, United States
Mickie G. Autry PhD, NP-C
Jackson, Mississippi, United States
Kathleen M. Young RNC NP
Kalispell, Montana, United States
Urogynecology Arts of New Jersey
East Brunswick, New Jersey, United States
Lynda M. Adamson
Galloway, New Jersey, United States
Women's Total Health
Hamburg, New Jersey, United States
Cindy Nevara APN
Vineland, New Jersey, United States
Jeanne Ann Dahl, RNC, WHNP
Albany, New York, United States
Meredith Schledorn
Cortland, New York, United States
Raj Mahajan MD
Oswego, New York, United States
Diane Stonemetz
West Seneca, New York, United States
Kathy Edwards
Minot, North Dakota, United States
Columbus OB/Gyn Inc.
Columbus, Ohio, United States
Holly Murphy
Columbus, Ohio, United States
Susan Frost
Columbus, Ohio, United States
Amy G Brenner M.D
Fairfield, Ohio, United States
Elizabeth D. Allen CNP
Gallipolis, Ohio, United States
William Shuler, MD
Tulsa, Oklahoma, United States
Deborah Malone
Bend, Oregon, United States
Anne Marie Moore, Womens Health Nurse Practitioner
Eugene, Oregon, United States
Cathleen Ann Folk FNP
Portland, Oregon, United States
Mary L Hagood, FNP-C
Roseburg, Oregon, United States
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, United States
Paulette Schreiber, CRNP
Saint Mary's, Pennsylvania, United States
Marie T Ziegler
West Chester, Pennsylvania, United States
Nancy Newman RNC, WHNP
Lexington, South Carolina, United States
Sharon Little
Collierville, Tennessee, United States
Margaret A. Hull
Franklin, Tennessee, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
John Pickel MD
Arlington, Texas, United States
Christopher J. Jayne, MD, FACOG
Houston, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Marney Kidwell RNC
San Antonio, Texas, United States
D. Crawford Allison MD
Waco, Texas, United States
Laura C. Maw
Lehi, Utah, United States
Betsy Browning
Bennington, Vermont, United States
Anne L Stephens
Chesapeake, Virginia, United States
Rand Gynecology, LLC
Chesapeake, Virginia, United States
Julie Spencer
Lansdowne, Virginia, United States
Patrice C Malena
Newport News, Virginia, United States
Ocean Beach Women's Clinic
Ilwaco, Washington, United States
Kimberly Scheer
Vashon, Washington, United States
Primary Care, PLLC
Christiansted, VI, Virgin Islands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PMT-4-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.