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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155593
• Other study ID #: 19-091
• Status: Completed
• Start date: November 8, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: November 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 15, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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