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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
Over Active Bladder Questionnaire
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
Female Sexual Function Index questionnaire
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Athena Pelvic Muscle Trainer | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Visit 4 (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Shaw, MD | Director of Women's Health, Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Foster MD | Birmingham | Alabama | 35205 | United States | ||
| La Mamma Spa |
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| Birmingham |
| Alabama |
| 35211 |
| United States |
| Kyle Chavers MD | Dothan | Alabama | 36305 | United States |
| Salud! for Women | Casa Grande | Arizona | 85122 | United States |
| New Horizons Women's Care | Chandler | Arizona | 85226 | United States |
| Barbara Wiggin PhD, ANP-C | Peoria | Arizona | 85381 | United States |
| Agnes Oblas APRN | Phoenix | Arizona | 85044 | United States |
| Arcadia Well Woman | Scottsdale | Arizona | 85251 | United States |
| Patricia A Faust | Tempe | Arizona | 85283 | United States |
| Beth Andresen | Tucson | Arizona | 85704 | United States |
| Teresa Mote RNC NP | Tucson | Arizona | 85704 | United States |
| Brenda Hanson-Smith, RN, DNS, OGNP | El Dorado Hills | California | 95726 | United States |
| Lynda Reed | Ontario | California | 91762 | United States |
| Rose Mary Mosher | Rolling Hills Est. | California | 90274 | United States |
| Evan Vapnek MD | San Diego | California | 92103 | United States |
| Marilyn Brooks | San Jacinto | California | 92583 | United States |
| Healthworks | San Luis Obispo | California | 93405 | United States |
| Maureen Allen | Northglenn | Colorado | 80234 | United States |
| Kristan Langdon, ANP-C | Parker | Colorado | 80134 | United States |
| Karen D. Adamson | Salida | Colorado | 81201 | United States |
| Merrilyn H. McNatt APRN | New London | Connecticut | 06320 | United States |
| Jean Ohliger APRN | South Windsor | Connecticut | 06074 | United States |
| Arlena Falcon | Blountstown | Florida | 32424 | United States |
| Carl Spirazza | Boynton Beach | Florida | 33472 | United States |
| Khadra Mohamoud Osman mD | Fort Lauderdale | Florida | 33316 | United States |
| Shelly E Kramer ARNP | Lake Worth | Florida | 33461 | United States |
| Ivonne M. Reynolds | Margate | Florida | 33316 | United States |
| Susan Chappuis, ARNP-C | Ormond Beach | Florida | 32174 | United States |
| Elizabeth Tsarnas | Stuart | Florida | 34994 | United States |
| Bayside Gynecology, P.A. | Venice | Florida | 34285 | United States |
| Jeffrey C Seiler, MD | West Palm Beach | Florida | 33407 | United States |
| Deborah Cothran WHNP-BC | Albany | Georgia | 31707 | United States |
| Elizabeth Killebrew MD | Fayetteville | Georgia | 30214 | United States |
| Michael D Benson | Deerfield | Illinois | 60015 | United States |
| Laurie Knoke | DeKalb | Illinois | 60115 | United States |
| Sherry Owen, APN | Gurnee | Illinois | 60031 | United States |
| Julie Snow | Park Ridge | Illinois | 60068 | United States |
| Kathryn A. Copeland | Carmel | Indiana | 46032 | United States |
| Matthew Sprunger MD | Fort Wayne | Indiana | 46825 | United States |
| Tamara Meisel ARNP | Lakin | Kansas | 67860 | United States |
| Richard F. Ford MD | Ashland | Kentucky | 41105 | United States |
| Women's Care Center | Lexington | Kentucky | 40503 | United States |
| Tammi K Herkey | Bossier City | Louisiana | 71111 | United States |
| Stefanie A Schultis | Covington | Louisiana | 70433 | United States |
| Steven Lenowitz, MD | Bel Air | Maryland | 21014 | United States |
| Kathryn Cervi | Columbia | Maryland | 21044 | United States |
| Elizabeth P Sipala | Galena | Maryland | 21635 | United States |
| Deborah A. Davis, MSN, CRNP | Prince Frederick | Maryland | 20678 | United States |
| Martha Klay | Great Barrington | Massachusetts | 01230 | United States |
| Pioneer Valley Urology | Springfield | Massachusetts | 01107 | United States |
| Margaret Duggan | Walpole | Massachusetts | 02081 | United States |
| Kathryn Koches | Dearborn | Michigan | 48124 | United States |
| Women's Health Care Specialists, PC | Paw Paw | Michigan | 49079 | United States |
| Isabel M Raposo | Riverview | Michigan | 48193 | United States |
| Laura Hintz | Saginaw | Michigan | 48638 | United States |
| Mickie G. Autry PhD, NP-C | Jackson | Mississippi | 39202 | United States |
| Kathleen M. Young RNC NP | Kalispell | Montana | 59901 | United States |
| Urogynecology Arts of New Jersey | East Brunswick | New Jersey | 08816 | United States |
| Lynda M. Adamson | Galloway | New Jersey | 08205 | United States |
| Women's Total Health | Hamburg | New Jersey | 07419 | United States |
| Cindy Nevara APN | Vineland | New Jersey | 08360 | United States |
| Jeanne Ann Dahl, RNC, WHNP | Albany | New York | 12205 | United States |
| Meredith Schledorn | Cortland | New York | 13045 | United States |
| Raj Mahajan MD | Oswego | New York | 13126 | United States |
| Diane Stonemetz | West Seneca | New York | 14224 | United States |
| Kathy Edwards | Minot | North Dakota | 58703 | United States |
| Columbus OB/Gyn Inc. | Columbus | Ohio | 43213 | United States |
| Holly Murphy | Columbus | Ohio | 43213 | United States |
| Susan Frost | Columbus | Ohio | 43222 | United States |
| Amy G Brenner M.D | Fairfield | Ohio | 45014 | United States |
| Elizabeth D. Allen CNP | Gallipolis | Ohio | 45631 | United States |
| William Shuler, MD | Tulsa | Oklahoma | 74133 | United States |
| Deborah Malone | Bend | Oregon | 97701 | United States |
| Anne Marie Moore, Womens Health Nurse Practitioner | Eugene | Oregon | 97401 | United States |
| Cathleen Ann Folk FNP | Portland | Oregon | 97219 | United States |
| Mary L Hagood, FNP-C | Roseburg | Oregon | 97470 | United States |
| Institute for Female Pelvic Medicine | Allentown | Pennsylvania | 18103 | United States |
| Paulette Schreiber, CRNP | Saint Mary's | Pennsylvania | 15857 | United States |
| Marie T Ziegler | West Chester | Pennsylvania | 19380 | United States |
| Nancy Newman RNC, WHNP | Lexington | South Carolina | 29072 | United States |
| Sharon Little | Collierville | Tennessee | 38017 | United States |
| Margaret A. Hull | Franklin | Tennessee | 37067 | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| John Pickel MD | Arlington | Texas | 76014 | United States |
| Christopher J. Jayne, MD, FACOG | Houston | Texas | 77030 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| Marney Kidwell RNC | San Antonio | Texas | 78232 | United States |
| D. Crawford Allison MD | Waco | Texas | 76708 | United States |
| Laura C. Maw | Lehi | Utah | 84043 | United States |
| Betsy Browning | Bennington | Vermont | 05201 | United States |
| Anne L Stephens | Chesapeake | Virginia | 23320 | United States |
| Rand Gynecology, LLC | Chesapeake | Virginia | 23320 | United States |
| Julie Spencer | Lansdowne | Virginia | 20176 | United States |
| Patrice C Malena | Newport News | Virginia | 23602 | United States |
| Ocean Beach Women's Clinic | Ilwaco | Washington | 98624 | United States |
| Kimberly Scheer | Vashon | Washington | 98070 | United States |
| Primary Care, PLLC | Christiansted | VI | 00820 | Virgin Islands |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053202 | Urinary Incontinence, Urge |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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