Urinary Incontinence
Conditions
Keywords
Urinary Urge Incontinence, Urinary Stress Incontinence, Urinary Mixed Incontinence
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
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.
Interventions
DEVICEAthena 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.
Sponsors
Athena Feminine Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess objective treatment outcomes of urge, stress or mixed incontinence. | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire | At Visit 4 (Week 12) | At the last visit, patients will complete a Subject Satisfaction Survey. |
Countries
United States, Virgin Islands
Outcome results
None listed