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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional In-Person Clinic Visit Arm | Placebo Comparator | 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 |
|
| Telemedicine Arm | Experimental | Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUFU Clinical Care Pathway for Overactive Bladder | Other | Treatment of OAB via the SUFU clinical care pathway |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Telemedicine | Other | Delivery of care via telemedicine |
|
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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |