Overactive Bladder Telemedicine Non-inferiority Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Other: SUFU Clinical Care Pathway for Overactive Bladder
* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Traditional In-Person Clinic Visit Arm<br>Patients will receive overactive bladder (OAB) treatment as described in the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB clinical care pathway. These patients will have all visits in-person | Other: SUFU Clinical Care Pathway for Overactive Bladder<br>* Treatment of OAB via the SUFU clinical care pathway<br>|
| Experimental: Telemedicine Arm<br>Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine | Other: SUFU Clinical Care Pathway for Overactive Bladder<br>* Treatment of OAB via the SUFU clinical care pathway<br>Other: Telemedicine<br>* Delivery of care via telemedicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGII | Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved | 1 year | 
| Incidence of Treatment-emergent adverse events (safety and tolerability) | Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions | 1 year | 
| Accumulated cost of visit to patient (Cost) | Cost of parking, travel, and other visit-associated expenses to patient | 1 year | 
| Accumulated time of visit for patient (Time) | Time of travel to visit, time of visit, wait time of visit | 1 year | 
| Overactive Bladder Symptoms | Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms | 1 year |