Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Leva Pelvic Digital Health System; Kegel exercises
Intervention type(s): Device; Other
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment