NCT04155593|Completed
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Sponsor study identifier
observational
135
1 country
1
Study Start
November 8, 2019
Actual (reported)Primary Completion
March 25, 2020
Actual (reported)Study Completion
July 15, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2019
Actual (reported)November 7, 2019
Actual (reported)November 8, 2019
Actual (reported)March 25, 2020
Actual (reported)July 15, 2020
Actual (reported)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
All patients who underwent onabotulinumtoxinA injections for overactive bladder by one of four fellowship trained female pelvic medicine and reconstructive surgeons at TriHealth between October 1, 2015 and October 1, 2019. These patients will be identified by CPT codes recorded in the EPIC electronic medical record.
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220, United States
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.
Rachel Pauls, MD
TriHealth - Cincinnati Urogynecology Associates
135 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2019
First Posted
November 7, 2019
Study Start
November 8, 2019
Actual (reported)Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
Contact the study team to confirm eligibility.
Primary Completion
March 25, 2020
Actual (reported)Study Completion
July 15, 2020
Actual (reported)Last Updated
September 2, 2020
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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