Clinical trial NCT04508153: Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
Official title: A Prospective Randomized Trial Comparing Efficacy of Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for the Treatment of Stress Urinary Incontinence: A Remote Digital Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Renovia, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OBVIO HEALTH USA, Inc.
name: University of Alabama at Birmingham
First posted: 2020-08-11
Enrollment: 369
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Capable of giving informed consent
* Possess a smartphone capable of interacting with the ObvioHealth and Renovia apps
* Self-reported SUI/SMUI symptoms of ≥ three months duration
* Diagnosis SMUI based on Medical, Epidemiologic and Social Aspects of Aging (MESA) stress symptom score (Percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
* English speaking
* Postmenopausal, post hysterectomy, or willing to use an acceptable method of birth control for the duration of the study
* Able to complete a bladder diary using the ObvioHealth app
* Able to complete electronic surveys and upload data
* Willing to provide contact information and respond to remote contact: phone calls, text messages, email
* Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress UI using other modalities (i.e. will not wear a pessary, participate in pelvic floor Physical Therapy or surgery) during the first 8 weeks

Exclusion Criteria:

* Absence of a vagina, per patient report
* Reports seeing or feeling a vaginal bulge or sensation of vaginal bulge
* Diagnosis of any neuromuscular disease that may contribute to UI (i.e., multiple sclerosis, spinal cord injury, Parkinson's Disease, etc.)
* Non-ambulatory, per patient report
* Currently pregnant or \<6 months post-partum per patient report
* Currently (or within the last 1 month) breast feeding
* Prior surgery for stress UI
* Previous PFMT: 2 visits within the last 3 months under a supervised therapeutic plan of care
* Currently taking, or has taken within the last 2 months, medication to treat UI
* Prior augmentation cystoplasty or artificial sphincter
* Implanted nerve stimulator for urinary symptoms, active within the past 60 days
* Participation in another clinical study within 30 days of screening
* Impaired cognitive function per patient report and evaluation of medication list
* Contraindication to the use of a vaginal probe
* Unable to understand instructions on the use of the leva® PDHS
* Unable to operate a smartphone app with use of Bluetooth and Wi-Fi connectivity

Primary outcomes:
measure: Efficacy - Urogenital Distress Inventory (UDI-6)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Efficacy - Bladder diaries
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Survey evaluations of incontinence Pelvic Organ Prolapse Distress Inventory (POPDI-6)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Patient Reported perception of general health Short Form-20 (SF-20)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Self-reported adherence
timeFrame: 4 weeks, 8 weeks
measure: Correlations between self-reported adherence and device reported adherence in the leva group
timeFrame: 4 weeks, 8 weeks
measure: Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
timeFrame: Through study completion, an average of 1 year
measure: Feedback on perception of treatment - likelihood of recommending to a friend
timeFrame: 4 weeks, 8 weeks
measure: Feedback on perception of treatment - interest in surgical treatment
timeFrame: 4 weeks, 8 weeks
measure: Survey evaluations of incontinence Colorectal-Anal Distress Inventory-8 (CRADI-8)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Survey evaluations of incontinence Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Survey evaluations of incontinence Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Survey evaluations of incontinence Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
measure: Survey evaluations of incontinence Patient Global Impression of Improvement (PGI-I)
timeFrame: 4 weeks, 8 weeks, 6 months and 12 months
measure: Survey evaluations of incontinence Pelvic Floor Impact Questionnaire (PFIQ)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama *** Virtual Trial May be enrolled from any US Location
state: Alabama
city: Irvine
country: United States
facility: Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location
state: California
city: Albuquerque
country: United States
facility: University of New Mexico *** Virtual Trial May be enrolled from any US Location
state: New Mexico
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly Richter, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Milena Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Gena Dunnivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern California Permanentae
name: Noelani M Guaderrama, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2022 Apr 1;139(4):606-615. doi: 10.1097/AOG.0000000000004725. Epub 2022 Mar 10.
citation: Weinstein MM, Pulliam SJ, Richter HE. Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design. Contemp Clin Trials. 2021 Jun;105:106406. doi: 10.1016/j.cct.2021.106406. Epub 2021 Apr 16.