MedTrace Logo

Oral vs Intravesical Analgesia for Office Bladder Botox Injections

NCT03755089 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-05-29

No results posted yet for this study

Summary

OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.

Conditions

  • Overactive Bladder Syndrome
  • Urge Incontinence
  • Urinary Incontinence
  • Detrusor Hyperreflexia
  • Detrusor Instability

Interventions

DRUG

Phenazopyridine

200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure

DRUG

Lidocaine 2% Injectable Solution

30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Lauren E Stewart, MD · Women and Infants Hospital of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-03-01
Completion
2021-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03755089 on ClinicalTrials.gov