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

Study Overview
=================
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.

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?

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: OnabotulinumtoxinA 100 Units


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 Botox Injections<br>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. | Drug: OnabotulinumtoxinA 100 Units<br>* 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.<br>* Other names: BOTOX;|
| Active Comparator: 20 Botox Injections<br>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. | Drug: OnabotulinumtoxinA 100 Units<br>* 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.<br>* Other names: BOTOX;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Post-Void Residual (PVR) | PVR using bladder scanner evaluates the post void residual in the bladder. | 2 weeks post procedure | 
| Post-Void Residual (PVR) | PVR using bladder scanner evaluates the post void residual in the bladder. | 12 weeks post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, Botox/OnabotulinumtoxinA, Pain, OAB, Non-neurogenic Overactive bladder