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Urinary IncontinencePhase 4DUETSNCT01073878

Athena Pelvic Muscle Trainer - DUETS Trial

A Phase 4 study testing Athena Pelvic Muscle Trainer in people with Urinary Incontinence, run by Athena Feminine Technologies, Inc. at 97 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 70 years, women only
Conditions the study is for
Urinary Incontinence
What is being tested?
Athena Pelvic Muscle Trainer
Type of treatment
Medical device
How many people
462 participants
Where
97 sitesin 2 countries
Study dates
Feb 2010to Jun 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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)
  • Subjects who chronically smoke (> 10 cigarettes per day)
  • Subjects required to do heavy lifting (> 40 pounds regularly)
  • Surgery within the past six months for incontinence, or use of other incontinence devices
  • 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.
  • Suspected infection or condition (e.g., diabetes) that would alter the subjects ability to participate or would confound the results of the trial

Trial locations and contacts

97 sites in 2 countries.

97 sites in 2 countries

United States96 sites

  • Deborah Cothran WHNP-BC

    Albany, Georgia, 31707

  • Jeanne Ann Dahl, RNC, WHNP

    Albany, New York, 12205

  • Institute for Female Pelvic Medicine

    Allentown, Pennsylvania, 18103

  • John Pickel MD

    Arlington, Texas, 76014

  • Richard F. Ford MD

    Ashland, Kentucky, 41105

  • Steven Lenowitz, MD

    Bel Air, Maryland, 21014

  • Deborah Malone

    Bend, Oregon, 97701

  • Betsy Browning

    Bennington, Vermont, 05201

  • John Foster MD

    Birmingham, Alabama, 35205

  • La Mamma Spa

    Birmingham, Alabama, 35211

  • Arlena Falcon

    Blountstown, Florida, 32424

  • Tammi K Herkey

    Bossier City, Louisiana, 71111

  • Carl Spirazza

    Boynton Beach, Florida, 33472

  • Kathryn A. Copeland

    Carmel, Indiana, 46032

  • Salud! for Women

    Casa Grande, Arizona, 85122

  • New Horizons Women's Care

    Chandler, Arizona, 85226

  • Anne L Stephens

    Chesapeake, Virginia, 23320

  • Rand Gynecology, LLC

    Chesapeake, Virginia, 23320

  • Sharon Little

    Collierville, Tennessee, 38017

  • Kathryn Cervi

    Columbia, Maryland, 21044

  • Columbus OB/Gyn Inc.

    Columbus, Ohio, 43213

  • Holly Murphy

    Columbus, Ohio, 43213

  • Susan Frost

    Columbus, Ohio, 43222

  • Meredith Schledorn

    Cortland, New York, 13045

  • Stefanie A Schultis

    Covington, Louisiana, 70433

  • Kathryn Koches

    Dearborn, Michigan, 48124

  • Michael D Benson

    Deerfield, Illinois, 60015

  • Laurie Knoke

    DeKalb, Illinois, 60115

  • Kyle Chavers MD

    Dothan, Alabama, 36305

  • Urogynecology Arts of New Jersey

    East Brunswick, New Jersey, 08816

  • Brenda Hanson-Smith, RN, DNS, OGNP

    El Dorado Hills, California, 95726

  • Anne Marie Moore, Womens Health Nurse Practitioner

    Eugene, Oregon, 97401

  • Amy G Brenner M.D

    Fairfield, Ohio, 45014

  • Elizabeth Killebrew MD

    Fayetteville, Georgia, 30214

  • Khadra Mohamoud Osman mD

    Fort Lauderdale, Florida, 33316

  • Matthew Sprunger MD

    Fort Wayne, Indiana, 46825

  • Margaret A. Hull

    Franklin, Tennessee, 37067

  • Elizabeth P Sipala

    Galena, Maryland, 21635

  • Elizabeth D. Allen CNP

    Gallipolis, Ohio, 45631

  • Lynda M. Adamson

    Galloway, New Jersey, 08205

  • Martha Klay

    Great Barrington, Massachusetts, 01230

  • Sherry Owen, APN

    Gurnee, Illinois, 60031

  • Women's Total Health

    Hamburg, New Jersey, 07419

  • Christopher J. Jayne, MD, FACOG

    Houston, Texas, 77030

  • Ocean Beach Women's Clinic

    Ilwaco, Washington, 98624

  • Mickie G. Autry PhD, NP-C

    Jackson, Mississippi, 39202

  • Kathleen M. Young RNC NP

    Kalispell, Montana, 59901

  • Shelly E Kramer ARNP

    Lake Worth, Florida, 33461

  • Tamara Meisel ARNP

    Lakin, Kansas, 67860

  • Julie Spencer

    Lansdowne, Virginia, 20176

  • Laura C. Maw

    Lehi, Utah, 84043

  • Women's Care Center

    Lexington, Kentucky, 40503

  • Nancy Newman RNC, WHNP

    Lexington, South Carolina, 29072

  • Ivonne M. Reynolds

    Margate, Florida, 33316

  • Kathy Edwards

    Minot, North Dakota, 58703

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • Merrilyn H. McNatt APRN

    New London, Connecticut, 06320

  • Patrice C Malena

    Newport News, Virginia, 23602

  • Maureen Allen

    Northglenn, Colorado, 80234

  • Lynda Reed

    Ontario, California, 91762

  • Susan Chappuis, ARNP-C

    Ormond Beach, Florida, 32174

  • Raj Mahajan MD

    Oswego, New York, 13126

  • Julie Snow

    Park Ridge, Illinois, 60068

  • Kristan Langdon, ANP-C

    Parker, Colorado, 80134

  • Women's Health Care Specialists, PC

    Paw Paw, Michigan, 49079

  • Barbara Wiggin PhD, ANP-C

    Peoria, Arizona, 85381

  • Agnes Oblas APRN

    Phoenix, Arizona, 85044

  • Cathleen Ann Folk FNP

    Portland, Oregon, 97219

  • Deborah A. Davis, MSN, CRNP

    Prince Frederick, Maryland, 20678

  • Isabel M Raposo

    Riverview, Michigan, 48193

  • Rose Mary Mosher

    Rolling Hills Est., California, 90274

  • Mary L Hagood, FNP-C

    Roseburg, Oregon, 97470

  • Laura Hintz

    Saginaw, Michigan, 48638

  • Paulette Schreiber, CRNP

    Saint Mary's, Pennsylvania, 15857

  • Karen D. Adamson

    Salida, Colorado, 81201

  • Urology San Antonio

    San Antonio, Texas, 78229

  • Marney Kidwell RNC

    San Antonio, Texas, 78232

  • Evan Vapnek MD

    San Diego, California, 92103

  • Marilyn Brooks

    San Jacinto, California, 92583

  • Healthworks

    San Luis Obispo, California, 93405

  • Arcadia Well Woman

    Scottsdale, Arizona, 85251

  • Jean Ohliger APRN

    South Windsor, Connecticut, 06074

  • Pioneer Valley Urology

    Springfield, Massachusetts, 01107

  • Elizabeth Tsarnas

    Stuart, Florida, 34994

  • Patricia A Faust

    Tempe, Arizona, 85283

  • Beth Andresen

    Tucson, Arizona, 85704

  • Teresa Mote RNC NP

    Tucson, Arizona, 85704

  • William Shuler, MD

    Tulsa, Oklahoma, 74133

  • Kimberly Scheer

    Vashon, Washington, 98070

  • Bayside Gynecology, P.A.

    Venice, Florida, 34285

  • Cindy Nevara APN

    Vineland, New Jersey, 08360

  • D. Crawford Allison MD

    Waco, Texas, 76708

  • Margaret Duggan

    Walpole, Massachusetts, 02081

  • Marie T Ziegler

    West Chester, Pennsylvania, 19380

  • Jeffrey C Seiler, MD

    West Palm Beach, Florida, 33407

  • Diane Stonemetz

    West Seneca, New York, 14224

Other trials in United States

Virgin Islands1 site

  • Primary Care, PLLC

    Christiansted, VI, 00820

About this study

Official title: 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
Read the 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.

Being tested
Athena Pelvic Muscle Trainer
Keywords
Urinary Urge Incontinence, Urinary Stress Incontinence, Urinary Mixed Incontinence
Medical subject headings
Urinary Incontinence, Urinary Incontinence, Urge, Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Athena Pelvic Muscle TrainerDevice

    Also called Athena PMT, PMT, Pelvic Muscle Trainer, Athena

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: At Visit 4 (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073878
Sponsor's protocol ID
PMT-4-001
Acronym
DUETS
Status last verified
Jul 2011
First submitted
17 Feb 2010
Last updated
14 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Athena Pelvic Muscle Trainer in people with Urinary Incontinence, run by Athena Feminine Technologies, Inc. at 97 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Virgin Islands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess objective treatment outcomes of urge, stress or mixed incontinence. (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01073878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2011.

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