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

NCT04305743 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-05

No results posted yet for this study

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.

Conditions

  • Urinary Bladder, Overactive
  • Incontinence, Urge
  • Incontinence, Urinary
  • Urinary Urge Incontinence
  • Urinary Frequency More Than Once at Night
  • Nocturia

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.

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • University of South Florida

    lead OTHER

Principal Investigators

  • Eric S Chang, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2021-01-01
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305743 on ClinicalTrials.gov