Clinical trial NCT04124939: Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Botox/OnabotulinumtoxinA
Pain
OAB
Non-neurogenic Overactive bladder
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Post Procedure Day 1
Secondary outcomes:
measure: Difference in Mean Urge Incontinence Episodes
timeFrame: Week 12 after procedure
measure: Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
timeFrame: Baseline
measure: Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
timeFrame: 2 weeks post procedure
measure: Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
timeFrame: 12 weeks post procedure
measure: Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
timeFrame: Baseline
measure: Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
timeFrame: 2 weeks post procedure
measure: Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
timeFrame: 12 weeks post procedure
measure: Post-Void Residual (PVR)
timeFrame: 2 weeks post procedure
measure: Post-Void Residual (PVR)
timeFrame: 12 weeks post procedure
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Urology clinic locations at Wake Forest Baptist Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Urology clinic locations at Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Catherine Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: