A Prospective Study Evaluating the Feasibility of Telemedicine Use in the Overactive Bladder Clinical Care Pathway: a Non-inferiority Study Assessing Patient Satisfaction and Progression to Third Line Overactive Bladder Therapies
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- University of California, Los Angeles
- Enrollment
- 177
- Locations
- 1
- Primary Endpoint
- Patient Satisfaction
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).
Detailed Description
This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.
Investigators
Victor W. Nitti, MD
Professor of Urology, Chief, Division of Female Pelvic Medicine and Reconstructive Surgery
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry
Exclusion Criteria
- •Active Urinary Tract Infection (UTI)
- •Stage 3 or 4 prolapse
- •Underlying neurologic condition contributing to OAB
- •Use of catheter
Outcomes
Primary Outcomes
Patient Satisfaction
Time Frame: 1 year
Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction
Secondary Outcomes
- PGII(1 year)
- Incidence of Treatment-emergent adverse events (safety and tolerability)(1 year)
- Overactive Bladder Symptoms(1 year)
- Accumulated cost of visit to patient (Cost)(1 year)
- Accumulated time of visit for patient (Time)(1 year)