Phase 4
Completed N=41
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Source: ClinicalTrials.gov NCT04124939 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Numeric Pain Rating Scale (NPRS) — 4; 3 score on a scale
◆ Published Evidence
Emerging
13citations · ~7 / year
Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial.
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.
Linked Publications
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Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial.
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 - 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 Post-Void Residual (PVR) |
17.5; 61 | — |
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
Data sourced from ClinicalTrials.gov (NCT04124939) and the linked publication. 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. Informational only — not medical advice.