Overactive Bladder
Conditions
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.
Interventions
OTHERSUFU Clinical Care Pathway for Overactive Bladder
Treatment of OAB via the SUFU clinical care pathway
OTHERTelemedicine
Delivery of care via telemedicine
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 1 year | Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGII | 1 year | Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved |
| Incidence of Treatment-emergent adverse events (safety and tolerability) | 1 year | Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions |
| Accumulated cost of visit to patient (Cost) | 1 year | Cost of parking, travel, and other visit-associated expenses to patient |
| Accumulated time of visit for patient (Time) | 1 year | Time of travel to visit, time of visit, wait time of visit |
| Overactive Bladder Symptoms | 1 year | Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms |
Countries
United States
Outcome results
None listed