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

Launched by RENOVIA, INC. · Aug 7, 2020

Keywords

ClinConnect Summary

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.
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Gender

FEMALE

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