In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04155593|
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : September 2, 2020
|Condition or disease|
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|
|Actual Enrollment :||135 participants|
|Official Title:||In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder; Does Measuring Post Void Residual Impact Management|
|Actual Study Start Date :||November 8, 2019|
|Actual Primary Completion Date :||March 25, 2020|
|Actual Study Completion Date :||July 15, 2020|
- Number of subjects having elevated PVR [ Time Frame: approximately 10 to 28 days following Botox injection ]Number of subjects with PVR > 200mL following Botox injection for OAB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155593
|United States, Ohio|
|Cincinnati Urogynecology Associates|
|Cincinnati, Ohio, United States, 45220|
|Principal Investigator:||Rachel Pauls, MD||TriHealth - Cincinnati Urogynecology Associates|