Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT04155593
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.
Study:
NCT04155593
Study Brief:
Protocol Section:
NCT04155593