In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder

In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder; Does Measuring Post Void Residual Impact Management

The purpose of this study is to describe the rates of elevated post void residual (PVR) (defined as >200mL) in Cincinnati Urogynecology Associates patients following Botox injection, as well as to document how many patients required treatment with clean intermittent self-catheterization (CISC).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder

Detailed Description

Approximately 16% of all women have symptoms of overactive bladder (OAB), whereas 30% of the elderly population are affected. Patients who do not respond to, or cannot tolerate, first and second line therapy with behavioral modifications and pharmacotherapy are offered additional treatment options. Third line therapy involves injection of onabotulinumtoxinA (Botox©, Allergen) into the bladder detrusor muscle.

Botox was approved for use for the diagnosis of OAB in 2013. Cincinnati Urogynecology Associates (CUA), TriHealth Inc. has incorporated intravesical Botox injections into the management algorithm for refractory OAB, since 2014. Currently, patients who fail to improve after a trial of first and second line therapy are offered treatment with Botox.

The standard practice is to request patients return to the office for a routine PVR measurement using straight catheterization within approximately two-four weeks following their Botox injection. This is done regardless if patients are exhibiting symptoms of urinary retention. Patients with an elevated PVR are treated with CISC if they are symptomatic.

Nevertheless, many studies suggest that patients are accurately able to self-identify symptoms of urinary retention, and treating asymptomatic urinary retention may not be necessary.

The investigators aim to describe how many patients with PVR >200mL had symptoms following intravesical injection of Botox for OAB.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent onabotulinumtoxinA injections for overactive bladder by one of four fellowship trained female pelvic medicine and reconstructive surgeons at TriHealth between October 1, 2015 and October 1, 2019. These patients will be identified by CPT codes recorded in the EPIC electronic medical record.

Description

Inclusion Criteria:

• OnabotulinumtoxinA injections in the bladder for overactive bladder
• Completed a post injection appointment at which time PVR was collected (approximately 10 to 28 days following Botox injection)
• Age >18
• English speaking

Exclusion Criteria:

• OnabotulinumtoxinA injection for any other cause than overactive bladder
• Patients requiring self-catheterization at baseline
• Failure to complete a postoperative appointment within 4 weeks of Botox injection

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects having elevated PVR	Number of subjects with PVR > 200mL following Botox injection for OAB	approximately 10 to 28 days following Botox injection

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Publications and helpful links

General Publications

• Aldrich ER, Pauls RN. Routine Office Assessment After OnabotulinumtoxinA Injection for Overactive Bladder Is Unnecessary to Detect Clinically Significant Voiding Dysfunction. Female Pelvic Med Reconstr Surg. 2021 Apr 1;27(4):225-229. doi: 10.1097/SPV.0000000000001001.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: November 1, 2019

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
• Other Study ID Numbers: 19-091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No