Athena Pelvic Muscle Trainer - DUETS Trial (DUETS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073878
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : July 14, 2011
Information provided by:
Athena Feminine Technologies, Inc.

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

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: Athena Pelvic Muscle Trainer Phase 4

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  (Clinical Trial)
Actual Enrollment : 462 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: 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 Names:
    • Athena PMT
    • PMT
    • Pelvic Muscle Trainer
    • Athena

Primary Outcome Measures :
  1. 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) ]
    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.

Secondary Outcome Measures :
  1. Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire [ Time Frame: At Visit 4 (Week 12) ]
    At the last visit, patients will complete a Subject Satisfaction Survey.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073878

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Sponsors and Collaborators
Athena Feminine Technologies, Inc.
Study Director: Julia Shaw, MD Director of Women's Health, Yale University

Responsible Party: David M. Berryman, Athena FT Identifier: NCT01073878     History of Changes
Other Study ID Numbers: PMT-4-001
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Athena Feminine Technologies, Inc.:
Urinary Urge Incontinence
Urinary Stress Incontinence
Urinary Mixed Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders