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| Name | Class |
|---|---|
| OBVIO HEALTH USA, Inc. | UNKNOWN |
| University of Alabama at Birmingham | OTHER |
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A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One group will receive routine care consisting of at-home Kegel exercises, and the other will be provided with a leva® device and instructions for use. Subjects in both groups will be assessed at baseline, then at 4 and 8 weeks for change and improvement of their symptoms. They will also be assessed at 6 and12 months after study completion.
This trial is entirely virtual. No office visits, specific locations, or physical examination will be required. Enrollment may occur from any location in the United States
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leva PDHS arm | Other | Upon randomization, subjects randomized to the leva® arm will receive the leva® PDHS, and instructions for how to download the smartphone app to facilitate use of the device. They will be instructed to use leva® based on the in-app training provided. Within the app, subjects will be instructed to use the leva® device to perform PFMT according to the training program provided through the smartphone app associated with the device. This entails 2 ½ minute training sessions, three times daily, 7 days per week for a total of 8 weeks. |
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| Kegel arm | Other | Subjects randomized to the Kegel arm will be provided links to view instructions on how to perform PFMT (written instructions per the handout adapted from Voices for PFD, the patient advocacy arm of the American Urogynecologic Society), as well as an audio/visual didactic instructing them to perform Pelvic Floor Muscle Exercises (PFME) three times daily, seven days per week throughout the 8-week study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leva Pelvic Digital Health System | Device | Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Urogenital Distress Inventory (UDI-6) | UDI-6 is a validated questionnaire assessing symptom presence and degree of bother. It will be used to compare the degree of symptom change in the leva arm vs the Kegel arm within and between groups. | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Efficacy - Bladder diaries | Bladder diaries evaluating the average number of stress-incontinence episodes in 3 days will be compared within and between groups | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survey evaluations of incontinence Pelvic Organ Prolapse Distress Inventory (POPDI-6) | POPDI-6 to assess the impact that pelvic floor disorders have on the health related quality of life in women | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Patient Reported perception of general health Short Form-20 (SF-20) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Richter, MD PhD | University of Alabama at Birmingham | Principal Investigator |
| Milena Weinstein, MD | Massachusetts General Hospital | Principal Investigator |
| Gena Dunnivan, MD | University of New Mexico | Principal Investigator |
| Noelani M Guaderrama, MD | Southern California Permanentae | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama *** Virtual Trial May be enrolled from any US Location | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38252280 | Derived | Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months. Int Urogynecol J. 2024 Apr;35(4):803-810. doi: 10.1007/s00192-023-05721-z. Epub 2024 Jan 22. | |
| 36701620 | Derived | Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months. Obstet Gynecol. 2023 Jan 1;141(1):199-206. doi: 10.1097/AOG.0000000000005036. Epub 2022 Nov 30. |
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A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.
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Subjects will be randomized to either the leva® arm or Kegel arm on a 1 to 1 ratio using block randomization. Prior to initiation of the trial, a randomization sequence will be generated by the ObvioHealth system. Participants will be automatically allocated the next available slot in the sequence at the time of their randomization and assigned to the leva® or Kegel group accordingly
| Kegel exercises | Other | Pelvic floor muscle training (PFMT), commonly referred to as "Kegel" exercises, is a first line conservative treatment for pelvic floor disorders, specifically stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (SMUI). |
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SF-20 survey on the participants perception of their general health. |
| Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Self-reported adherence | Visual Analog Score for self-reported adherence to the prescribed therapy, 0% = did not adhere to the prescribed treatment regimen/did not perform any Pelvic Floor exercises to 100% = adhered to the prescribed treatment regimen | 4 weeks, 8 weeks |
| Correlations between self-reported adherence and device reported adherence in the leva group | Self-reported adherence and Device-reported adherence in the Leva group will be correlated | 4 weeks, 8 weeks |
| Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) | Monitored for adverse events and serious adverse events | Through study completion, an average of 1 year |
| Feedback on perception of treatment - likelihood of recommending to a friend | Visual Analog Score of likelihood of recommending to a friend Scale from 0-100%. 0%= Will not recommend to a friend to 100%=Will definitely recommend to a friend. | 4 weeks, 8 weeks |
| Feedback on perception of treatment - interest in surgical treatment | Visual Analog Score of interest in surgical treatment for urinary incontinence. Scale from 0-100%. 0%= Not interested at all in surgical treatment to 100%=Extremely interested in surgical treatment. | 4 weeks, 8 weeks |
| Survey evaluations of incontinence Colorectal-Anal Distress Inventory-8 (CRADI-8) | CRADI-8 to assess the impact that pelvic floor disorders have on the health related quality of life in women | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Survey evaluations of incontinence Pelvic Floor Distress Inventory (PFDI-20) | PFDI-20 to assess the impact that pelvic floor disorders have on the health related quality of life in women | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Survey evaluations of incontinence Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) | PISQ-IR to assess the impact that pelvic floor disorders have on the health related quality of life in women | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Survey evaluations of incontinence Patient Global Impression of Severity (PGI-S) | PGI-S is the participants description of how their urinary tract condition is currently. | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Survey evaluations of incontinence Patient Global Impression of Improvement (PGI-I) | PGI-I is the participants description on how their urinary symptoms are now, compared with how they were before they began the study. | 4 weeks, 8 weeks, 6 months and 12 months |
| Survey evaluations of incontinence Pelvic Floor Impact Questionnaire (PFIQ) | PFIQ to assess the impact that pelvic floor disorders have on the health related quality of life in women | Baseline, 4 weeks, 8 weeks, 6 months and 12 months |
| Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location |
| Irvine |
| California |
| 92618 |
| United States |
| University of New Mexico *** Virtual Trial May be enrolled from any US Location | Albuquerque | New Mexico | 87112 | United States |
| 35271539 | Derived | Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2022 Apr 1;139(4):606-615. doi: 10.1097/AOG.0000000000004725. Epub 2022 Mar 10. |
| 33866003 | Derived | Weinstein MM, Pulliam SJ, Richter HE. Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design. Contemp Clin Trials. 2021 Jun;105:106406. doi: 10.1016/j.cct.2021.106406. Epub 2021 Apr 16. |
| 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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