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

Wake Forest University Health Sciences41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Overactive Bladder

Interventions

OnabotulinumtoxinA 100 UnitsDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

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, United States

Outcomes

Primary Outcomes

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.

Time frame: Post Procedure Day 1

Secondary Outcomes

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

Time frame: 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

Time frame: Baseline

Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

Time frame: 2 weeks post procedure

Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms

Time frame: 12 weeks post procedure

Data from ClinicalTrials.gov

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