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 * 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. * Following completion of e-consent and screening, including an initial bladder diary and introductory phone call to review the study requirements, subjects are considered officially enrolled. * A series of baseline assessments will be administered to all subjects to evaluate symptom severity, frequency and impact. * Subjects will then 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. * Prior to beginning the program, subjects in the Kegel arm will receive printed instructions for PFMT with Kegel exercises. Subjects in the leva® arm will be shipped the leva® digital device, along with instructions for use and how to download the corresponding digital app. Day 1 of the study begins the day following receipt of materials. * Study population: women with SUI or SMUI. * The study requires no office visits. All participant data will be entered in the subject's smartphone using a custom designed mobile application. Participants will be able to interact with the app throughout the study period and will be presented with surveys and a voiding diary on a specified schedule during an 8-week treatment period. There will also be expected post-intervention follow up surveys at 6- and 12-months * Using virtual recruiting, a total of up to 350 subjects will be enrolled in the trial. * Subjects in both arms will have three scheduled phone calls with study staff during the first two weeks of treatment. * Subjects can speak to the study staff at any time via an in-app chat function, the phone, or videoconference.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
369
Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.
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).
University of Alabama *** Virtual Trial May be enrolled from any US Location
Birmingham, Alabama, United States
Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location
Irvine, California, United States
University of New Mexico *** Virtual Trial May be enrolled from any US Location
Albuquerque, New Mexico, United States
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.
Time frame: 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
Time frame: Baseline and 8 weeks
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
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Patient Reported perception of general health Short Form-20 (SF-20)
SF-20 survey on the participants perception of their general health.
Time frame: 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
Time frame: 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
Time frame: 4 weeks, 8 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Monitored for adverse events and serious adverse events
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
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