Status:
COMPLETED
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-90 years
Phase:
PHASE4
Brief 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 incontinen...
Detailed 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 intra...
Eligibility Criteria
Inclusion
- 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
- 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
- Post-void residual (PVR) \>150 cc (measured by bladder scan or by catheterization) prior to enrollment
- History of chronic pain or pain syndromes
Key Trial Info
Start Date :
November 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04124939
Start Date
November 10 2019
End Date
February 23 2023
Last Update
April 17 2024
Active Locations (2)
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1
Urology clinic locations at Wake Forest Baptist Medical Center
Greensboro, North Carolina, United States, 27455
2
Urology clinic locations at Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157