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

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: OnabotulinumtoxinA 100 Units

• Registration Number: NCT04124939
• Lead Sponsor: Wake Forest University Health Sciences

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 incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

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 intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-14
• Study Start: 2019-11-10
• Status Verified: 2022-08
• Primary Completion: 2022-11-09
• Study Completion: 2023-02-23
• Results First Submitted: 2023-08-02
• Results First Submitted QC: 2023-10-11
• Results First Posted: 2023-10-13
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 Botox Injections	OnabotulinumtoxinA 100 Units	100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
10 Botox Injections	OnabotulinumtoxinA 100 Units	100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	Post Procedure Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life	Baseline	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.
Difference in Mean Urge Incontinence Episodes	Week 12 after procedure	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
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	12 weeks post procedure	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
Post-Void Residual (PVR)	12 weeks post procedure	PVR using bladder scanner evaluates the post void residual in the bladder.
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life	12 weeks post procedure	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.

Trial Locations

Locations (1)

Urology clinic locations at Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States