Status:
COMPLETED
Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
Lead Sponsor:
Renovia, Inc.
Collaborating Sponsors:
OBVIO HEALTH USA, Inc.
University of Alabama at Birmingham
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-100 years
Phase:
NA
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 ...
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 ran...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT04508153
Start Date
October 1 2020
End Date
September 1 2021
Last Update
December 9 2021
Active Locations (3)
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1
University of Alabama *** Virtual Trial May be enrolled from any US Location
Birmingham, Alabama, United States, 35233
2
Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location
Irvine, California, United States, 92618
3
University of New Mexico *** Virtual Trial May be enrolled from any US Location
Albuquerque, New Mexico, United States, 87112