Pelvic Floor Muscle Training With Leva System for Urge Incontinence

Overactive Bladder Clinical Trial

Official title:

Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03923348
• Other study ID #: 18-71
• Status: Terminated
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: May 4, 2020

Study information

• Verified date: June 2020
• Source: The Christ Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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 wash-out period)

• Brink Score > 3 (see below)

• Access to smartphone technology, including iOS or Android™

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Mixed Urinary Incontinence
• Overactive Bladder
• Urge Urinary Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

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.

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Christ Hospital	Renovia, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Brink CA, Sampselle CM, Wells TJ, Diokno AC, Gillis GL. A digital test for pelvic muscle strength in older women with urinary incontinence. Nurs Res. 1989 Jul-Aug;38(4):196-9. — View Citation

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. — View Citation

Hundley AF, Wu JM, Visco AG. A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005 May;192(5):1583-91. — View Citation

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. — View Citation

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. — View Citation

Lamin E, Parrillo LM, Newman DK, Smith AL. Pelvic Floor Muscle Training: Underutilization in the USA. Curr Urol Rep. 2016 Feb;17(2):10. doi: 10.1007/s11934-015-0572-0. Review. — View Citation

Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urogenital Distress Inventory	The Urogenital Distress Inventory (UDI) is a 19-item questionnaire assessing subjective symptoms of pelvic floor disorders including incontinence. The 19 items fall into one of three subscales (Irritative symptoms, Obstructive symptoms, and Stress Symptoms). . The subject responds to each item by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. For scoring, first each subscale score is calculated by finding the mean score of items within the subscale section, subtracting 1, and multiplying that by 100/3. Next, the subscale scores are summed to determine the overall UDI score with possible scores ranging from 0-300. High scores indicate greater symptoms severity.	Change from Baseline UDI score to 8 weeks and 6 months post-intervention
Secondary	Incontinence Impact Questionnaire Short Form (IIQ-7)	Validated short-form version of the Incontinence Impact Questionnaire used to describe incontinence-related quality of life. It consists of 7 items assessing four general areas including travel, social, emotional, and physical activities. For each item, the subject responds by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. Scores are generated by finding the mean score for each item and multiplying that by 100/3. Higher scores indicate greater negative impact on quality of life.	Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention
Secondary	Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary	A voiding diary is considered standard of care in the work-up of a patient with incontinence to better characterize real-life drinking and voiding habits. The number of urge urinary incontinence episodes is determined by adding up the incontinence episodes recorded by the patient that were associated with an urge to get to the bathroom. More incontinence episodes means a greater severity of incontinence	Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention