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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03923348
Recruitment Status Terminated (Slow Recruitment and Re-prioritizing of Sponsor-funding)
First Posted April 22, 2019
Last update posted July 1, 2020
This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.
Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined.
|Experimental: Leva Users
Subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks.
Device: Leva device
The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Age 18-85 years old
- Urinary incontinence for ≥ 3 months
- Reporting at least "moderate bother" on Item 2 on the UDI-6, "Do you experience urine
leakage in related to the feeling of urgency" (on new patient paperwork)
- If mixed urinary incontinence, Medical Epidemiologic Social Aspect of Aging Urinary
Incontinence Questionnaire (MESA) score indicating urge-predominant MUI (Urge subscale
% > Stress subscale %)
- Presence of ≥ 1 UUI episode on 3-d bladder diary (see Appendix 2)
- Is the baseline bladder diary consistent with the patient's typical habits?
- Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2 week
- Brink Score > 3 (see below)
- Access to smartphone technology, including iOS or Android™
- Non-English speakers
- Severely impaired mobility or cognition
- Spinal cord injury or advanced/severe neurologic condition including Multiple
Sclerosis, Parkinson's Disease
- Concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months
- Received intravesical botulinum injection within the previous 12 months
- History of implanted nerve stimulator for incontinence
- History of prior sling or vaginal mesh placement
- Previous diagnosis of Interstitial cystitis
- Active pelvic organ malignancy
- History of pelvic radiation
- Urethral obstruction
- Urinary retention or prolonged catheter use
- Less than 12 months post-partum are currently pregnant, or plan to become pregnant in
the following 12 months
- Untreated symptomatic urinary tract infection
- Unevaluated hematuria
- Medical instability
- Not available for follow-up in 6 months
- Participation in other research trials that could influence results of this study
United States, Ohio
The Christ Hospital
The Christ Hospital
Principal Investigator: Anne M Stachowicz, MD Urogynecology Fellow
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Monteiro S, Riccetto C, Araújo A, Galo L, Brito N, Botelho S. Efficacy of pelvic floor muscle training in women with overactive bladder syndrome: a systematic review. Int Urogynecol J. 2018 Nov;29(11):1565-1573. doi: 10.1007/s00192-018-3602-x. Epub 2018 Apr 11.
Kammerer-Doak D, Rizk DE, Sorinola O, Agur W, Ismail S, Bazi T. Mixed urinary incontinence: international urogynecological association research and development committee opinion. Int Urogynecol J. 2014 Oct;25(10):1303-12. doi: 10.1007/s00192-014-2485-8. Epub 2014 Aug 5. Review.
Rosenblatt P, Pulliam S, McKinney J, Sutherland R, Iglesias R. The leva incontinence system for the treatment of mild to moderate urinary incontinence: A pilot study. Female Pelvic Med Reconstr Surg.
Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994 Oct;3(5):291-306.
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9.
Dyer KY, Xu Y, Brubaker L, Nygaard I, Markland A, Rahn D, Chai TC, Stoddard A, Lukacz E; Urinary Incontinence Treatment Network (UITN). Minimum important difference for validated instruments in women with urge incontinence. Neurourol Urodyn. 2011 Sep;30(7):1319-24. doi: 10.1002/nau.21028. Epub 2011 May 11.
Jimenez-Cidre MA, Lopez-Fando L, Esteban-Fuertes M, Prieto-Chaparro L, Llorens-Martinez FJ, Salinas-Casado J, Castro-Diaz D, Müller-Arteaga C, Adot-Zurbano JM, Rodriguez-Escobar F, Gutierrez C, Arlandis-Guzman S, Bonillo-Garcia MA, Madurga-Patuel B, Leva-Vallejo M, Franco de Castro A, Peri-Cusi L, Conejero-Sugrañes J, Jimenez-Calvo J, Rebollo P, Mora A. The 3-day bladder diary is a feasible, reliable and valid tool to evaluate the lower urinary tract symptoms in women. Neurourol Urodyn. 2015 Feb;34(2):128-32. doi: 10.1002/nau.22530. Epub 2013 Nov 22.