Viewing Study NCT04155593



Ignite Creation Date: 2024-05-06 @ 1:53 PM
Last Modification Date: 2024-10-26 @ 1:21 PM
Study NCT ID: NCT04155593
Status: COMPLETED
Last Update Posted: 2020-09-02
First Post: 2019-11-05

Brief Title: In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder
Sponsor: TriHealth Inc
Organization: TriHealth Inc

Study Overview

Official Title: In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder Does Measuring Post Void Residual Impact Management
Status: COMPLETED
Status Verified Date: 2019-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None