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

NCT ID: NCT04155593

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2020-07-15

Brief 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).

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.

Conditions

Overactive Bladder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33770805 (View on PubMed)

Other Identifiers

19-091

Identifier Type: -

Identifier Source: org_study_id