Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    40
  • sponsor
    Wake Forest University Health Sciences
Updated on 30 June 2022
botox
anticholinergic agents
incontinence
onabotulinumtoxina
intermittent catheterization
micturition chart

Summary

The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

Description

This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

Details
Condition Overactive Bladder
Treatment OnabotulinumtoxinA 100 UNT
Clinical Study IdentifierNCT04124939
SponsorWake Forest University Health Sciences
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Female gender
\. At least 18 years of age
\. Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder
\. Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization)
\. Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
\. Able to give informed consent

Exclusion Criteria

\. Male gender
\. Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida)
\. Acute urinary tract infection
\. Treatment with Botox® toxin for other conditions
\. Allergy to Botox® toxin
\. Hematuria that has not been worked up
\. Known bladder malignancy
\. Previous history of bladder augmentation
\. Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
\. Currently taking aminoglycoside antibiotics
\. PVR >150 cc (measured by bladder scan or by catheterization) prior to enrollment
\. History of chronic pain or pain syndromes
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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