Phase 4 N=41 Randomized Single-blind Treatment

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

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT04124939 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Numeric Pain Rating Scale (NPRS) — 4; 3 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: OnabotulinumtoxinA 100 Units (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Numeric Pain Rating Scale (NPRS)	4; 3	—
SECONDARY Difference in Mean Urge Incontinence Episodes	1.64; 1.35	—
SECONDARY Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	15.53; 16.41	—
SECONDARY Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	15.53; 16.41	—
SECONDARY Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms	15.53; 16.41	—
SECONDARY Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life	56.04; 47.94	—
SECONDARY Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life	27.74; 27.00	—
SECONDARY Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life	27.74; 27.00	—
SECONDARY Post-Void Residual (PVR)	17.5; 61	—
SECONDARY Post-Void Residual (PVR)	17.5; 61	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04124939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.