Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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).

Condition or disease
Overactive Bladder

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Ohio
Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Layout table for investigator information
Principal Investigator: Rachel Pauls, MD TriHealth - Cincinnati Urogynecology Associates
Layout table for additonal information
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT04155593    
Other Study ID Numbers: 19-091
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations