Athena Pelvic Muscle Trainer - DUETS Trial

Completed · Phase 4

Conditions studied: Urinary Incontinence

In brief

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

Key facts

Study ID

NCT01073878

Run by

Athena Feminine Technologies, Inc.

People needed

462

Starts

2010-02-01

Expected to finish

2011-06-01

Last updated by the study team

2011-07-14

Who can join

Age: 30 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• 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

Where it is running

• 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
• John Foster MD — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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