search
Back to results

Pelvic Floor Muscle Training With Leva System for Urge Incontinence

Primary Purpose

Overactive Bladder, Urge Urinary Incontinence, Mixed Urinary Incontinence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leva device
Sponsored by
The Christ Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring female urinary incontinence, urge urinary incontinence, urgency, frequency, overactive bladder, pelvic floor muscle training, biofeedback

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Christ Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leva Users

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 18, 2019
Last Updated
June 30, 2020
Sponsor
The Christ Hospital
Collaborators
Renovia, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03923348
Brief Title
Pelvic Floor Muscle Training With Leva System for Urge Incontinence
Official Title
Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow Recruitment and Re-prioritizing of Sponsor-funding
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Christ Hospital
Collaborators
Renovia, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Urinary Incontinence, Mixed Urinary Incontinence
Keywords
female urinary incontinence, urge urinary incontinence, urgency, frequency, overactive bladder, pelvic floor muscle training, biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-blinded non-comparative pilot trial in which 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leva Users
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Leva device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urogenital Distress Inventory
Description
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.
Time Frame
Change from Baseline UDI score to 8 weeks and 6 months post-intervention
Secondary Outcome Measure Information:
Title
Incontinence Impact Questionnaire Short Form (IIQ-7)
Description
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.
Time Frame
Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention
Title
Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary
Description
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
Time Frame
Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne M Stachowicz, MD
Organizational Affiliation
Urogynecology Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24007713
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.
Results Reference
background
PubMed Identifier
29644384
Citation
Monteiro S, Riccetto C, Araujo 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.
Results Reference
background
PubMed Identifier
25091925
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.
Results Reference
background
PubMed Identifier
26757904
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
7841963
Citation
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. doi: 10.1007/BF00451721.
Results Reference
background
PubMed Identifier
7780440
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. doi: 10.1002/nau.1930140206.
Results Reference
background
PubMed Identifier
21563210
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.
Results Reference
background
PubMed Identifier
24264859
Citation
Jimenez-Cidre MA, Lopez-Fando L, Esteban-Fuertes M, Prieto-Chaparro L, Llorens-Martinez FJ, Salinas-Casado J, Castro-Diaz D, Muller-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-Sugranes 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.
Results Reference
background
PubMed Identifier
15902162
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. doi: 10.1016/j.ajog.2004.11.015.
Results Reference
background
PubMed Identifier
2748352
Citation
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.
Results Reference
background

Learn more about this trial

Pelvic Floor Muscle Training With Leva System for Urge Incontinence

We'll reach out to this number within 24 hrs