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

NCT ID: NCT05157295

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder Syndrome Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group of participants will receive the "experimental" treatment, which is 4 injections, and the other group of participants will receive the "standard" treatment, which is 20 injections.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites

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.

Group Type ACTIVE_COMPARATOR

OnabotulinumtoxinA

Intervention Type DRUG

100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites

Interventions

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OnabotulinumtoxinA

100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Lanzer, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Emily Grandprey, DO

Role: STUDY_DIRECTOR

Augusta University

Emily Lluch

Role: STUDY_DIRECTOR

Augusta University

Ahana Gaurav

Role: STUDY_DIRECTOR

Augusta University

Central Contacts

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Stacy Carrigan

Role: CONTACT

Phone: 7067214959

Email: [email protected]

Other Identifiers

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1791493

Identifier Type: -

Identifier Source: org_study_id