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RECRUITING
NCT04305743
PHASE4

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Sponsor: University of South Florida

View on ClinicalTrials.gov

Summary

Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

Official title: Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2019-10-09

Completion Date

2021-06-01

Last Updated

2020-11-05

Healthy Volunteers

No

Interventions

DRUG

OnabotulinumtoxinA 100 UNT

Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.

Locations (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of South Florida Health South Tampa Center for Advanced Healthcare

Tampa, Florida, United States