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

Overactive Bladder Clinical Trial

Official title:

A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124939
• Other study ID #: IRB00059454
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2019
• Est. completion date: February 23, 2023

Study information

• Verified date: August 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 23, 2023
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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
• Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment
• History of chronic pain or pain syndromes

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• OnabotulinumtoxinA 100 Units
BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Locations

Country	Name	City	State
United States	Urology clinic locations at Wake Forest Baptist Medical Center	Greensboro	North Carolina
United States	Urology clinic locations at Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.	Post Procedure Day 1
Secondary	Difference in Mean Urge Incontinence Episodes	The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure	Week 12 after procedure
Secondary	Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life	Baseline
Secondary	Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life	2 weeks post procedure
Secondary	Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life	12 weeks post procedure
Secondary	Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life	Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.	Baseline
Secondary	Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life	Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.	2 weeks post procedure
Secondary	Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life	Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.	12 weeks post procedure
Secondary	Post-Void Residual (PVR)	PVR using bladder scanner evaluates the post void residual in the bladder.	2 weeks post procedure
Secondary	Post-Void Residual (PVR)	PVR using bladder scanner evaluates the post void residual in the bladder.	12 weeks post procedure