Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Overactive Bladder Syndrome
• Intervention / Treatment: Drug: OnabotulinumtoxinA

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stacy Carrigan; Phone Number: 7067214959; Email: scarrigan@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• females, adults 18 years of age and older, diagnosed with OAB

Exclusion Criteria:

• bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; 100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome.	Drug: OnabotulinumtoxinA; 100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites
ACTIVE_COMPARATOR: Control Group; 100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome.	Drug: OnabotulinumtoxinA; 100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived pain of each participant before, during, and after the procedure on a scale of 0-10	The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible).	within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure	The Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire is a validated instrument administered by the physician. It asks participants if they had benefit, satisfaction, and a willingness to continue from a specific treatment. If yes, responses range from 1(little benefit, little, satisfaction, a little bit willing) to 2(much benefit, very satisfied, very willing).	2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure
Change in extent of Overactive Bladder Symptoms before and after receiving the procedure	The Overactive Bladder questionnaire (OAB-q) short form is a validated instrument that measures the extent to which participants have various symptoms of OAB over the past 4 weeks. The responses range from 1(not at all) to 6(a very great deal).	Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
The Prevalence of complications with botox after receiving the procedure	The Complications with Botox survey is an instrument used to measure if and how many times participants experienced UTIs, difficulty urinating, or hematuria after the Botox procedure. Participants self-report the number of times if they have experienced the side effect.	2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Jennifer Lanzer, MD, Augusta University; Study Director: Emily Grandprey, DO, Augusta University; Study Director: Emily Lluch, Augusta University; Study Director: Ahana Gaurav, Augusta University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (ACTUAL): December 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1791493

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes