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Athena Pelvic Muscle Trainer - DUETS Trial

This study has been completed.
Sponsor:
Information provided by:
Athena Feminine Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01073878
First received: February 17, 2010
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Urinary Incontinence
 Device: Athena Pelvic Muscle Trainer
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Athena PMT - Device to Treat Urinary Incontinence - Effectiveness, Tolerability and Satisfaction "Athena D.U.E.T.S. Trial"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Athena Feminine Technologies, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    At the last visit, patients will complete a Subject Satisfaction Survey.


Enrollment: 462
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073878

  Show 97 Study Locations
Sponsors and Collaborators
Athena Feminine Technologies, Inc.
Investigators
Study Director: Julia Shaw, MD Director of Women's Health, Yale University
  More Information

No publications provided

Responsible Party: David M. Berryman, Athena FT
ClinicalTrials.gov Identifier: NCT01073878     History of Changes
Other Study ID Numbers: PMT-4-001
Study First Received: February 17, 2010
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board

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
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013