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A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leva Arm | Experimental | Subjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months. |
|
| Kegel Arm | Active Comparator | Subjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leva | Device | Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises. |
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| Measure | Description | Time Frame |
|---|---|---|
| PGI-I | PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better." | 8 weeks after randomization |
| UDI-6 | Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms | 8 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 3-day voiding diary | An objective evaluation of urinary incontinence | 8 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Adherence to the exercise regimen will be evaluated | 8 weeks, 6 months, 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Cedars-Sinai Medical Group |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2018 | Dec 10, 2018 |
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Assessments of pelvic floor muscle function accomplished by testing at baseline, 4-weeks (mid-study) and 8-weeks will be performed by blinded assessor
| PFDx | Device | All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises. |
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Univeristy of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2019 | Aug 27, 2019 | SAP_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2021 | Dec 1, 2021 | 10 |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| 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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