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Pelvic Floor Muscle Training With Leva System for Urge Incontinence

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ClinicalTrials.gov Identifier: NCT03923348
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Renovia, Inc.
Information provided by (Responsible Party):
Anne Stachowicz, The Christ Hospital

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urge Urinary Incontinence Mixed Urinary Incontinence Device: Leva device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Urogenital Distress Inventory [ Time Frame: Change from Baseline UDI score to 8 weeks and 6 months post-intervention ]
    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 :
  1. Incontinence Impact Questionnaire Short Form (IIQ-7) [ Time Frame: Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention ]
    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.

  2. Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary [ Time Frame: Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention ]
    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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923348


Contacts
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Contact: Anne M Stachowicz, MD 513-585-3474 anne.stachowicz@thechristhospital.com
Contact: Mickey M Karram, MD 513-585-3474

Sponsors and Collaborators
The Christ Hospital
Renovia, Inc.
Investigators
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Principal Investigator: Anne M Stachowicz, MD Urogynecology Fellow

Publications:
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.

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Responsible Party: Anne Stachowicz, Fellow Physician, The Christ Hospital
ClinicalTrials.gov Identifier: NCT03923348     History of Changes
Other Study ID Numbers: 18-71
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anne Stachowicz, The Christ Hospital:
female urinary incontinence
urge urinary incontinence
urgency
frequency
overactive bladder
pelvic floor muscle training
biofeedback

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases