Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence

NCT04508153 | Completed FDA Device

• 1 other identifier: OBVIO-REN-001
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 3

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline and 8 weeks

Secondary Outcomes (13)

• Survey evaluations of incontinence Pelvic Organ Prolapse Distress Inventory (POPDI-6)

  Baseline, 4 weeks, 8 weeks, 6 months and 12 months

• Patient Reported perception of general health Short Form-20 (SF-20)

  Baseline, 4 weeks, 8 weeks, 6 months and 12 months

• Self-reported adherence

  4 weeks, 8 weeks

• Correlations between self-reported adherence and device reported adherence in the leva group

  4 weeks, 8 weeks

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

  Through study completion, an average of 1 year

Study Arms (2)

Leva PDHS arm

OTHER

Upon randomization, subjects randomized to the leva® arm will receive the leva® PDHS, and instructions for how to download the smartphone app to facilitate use of the device. They will be instructed to use leva® based on the in-app training provided. Within the app, subjects will be instructed to use the leva® device to perform PFMT according to the training program provided through the smartphone app associated with the device. This entails 2 ½ minute training sessions, three times daily, 7 days per week for a total of 8 weeks.

Device: Leva Pelvic Digital Health System

Kegel arm

OTHER

Subjects randomized to the Kegel arm will be provided links to view instructions on how to perform PFMT (written instructions per the handout adapted from Voices for PFD, the patient advocacy arm of the American Urogynecologic Society), as well as an audio/visual didactic instructing them to perform Pelvic Floor Muscle Exercises (PFME) three times daily, seven days per week throughout the 8-week study period.

Other: Kegel exercises

Interventions

Leva Pelvic Digital Health System DEVICE

Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.

Leva PDHS arm

Kegel exercises OTHER

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).

Kegel arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renovia, Inc.: lead
• OBVIO HEALTH USA, Inc.: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (3)

University of Alabama *** Virtual Trial May be enrolled from any US Location

Birmingham, Alabama, 35233, United States

Location

Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location

Irvine, California, 92618, United States

Location

University of New Mexico *** Virtual Trial May be enrolled from any US Location

Albuquerque, New Mexico, 87112, United States

Location

Related Publications (3)

• Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months. Obstet Gynecol. 2023 Jan 1;141(1):199-206. doi: 10.1097/AOG.0000000000005036. Epub 2022 Nov 30.

  PMID: 36701620 DERIVED

• 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.

  PMID: 35271539 DERIVED

• 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.

  PMID: 33866003 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Holly Richter, MD PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Milena Weinstein, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Gena Dunnivan, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Noelani M Guaderrama, MD

  Southern California Permanentae

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: October 1, 2020
• Primary Completion: April 23, 2021
• Study Completion: September 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)