Phase 4
N=116
Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial
Overactive Bladder · Urinary Urge Incontinence · Overactive Bladder Syndrome · Urinary Incontinence, Urge · Urge Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT05308979 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF) — -31.2; -39.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OnabotulinumtoxinA 100 UNT [Botox] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF) |
-31.2; -39.5 | — |
| SECONDARY Change in Overactive Bladder Questionnaire Long Form Score (Health Related Quality of Life)(OAB-Q LF HRQL Subscale) |
31.4; 34.8 | — |
| SECONDARY Post-void Residual (PVR) |
83.4; 83.5 | — |
| SECONDARY Number of Participants With Urinary Tract Infection (UTI) |
8; 7 | — |
| SECONDARY Number of Patients With Patient Global Impression - Improvement (PGI-I) Score of 1 |
11; 11 | — |
| SECONDARY Visual Analogue Scale (VAS) - Pain |
25.7; 31.7 | — |
Summary
Patients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.
Eligibility Criteria
Inclusion Criteria
- Female
- 18 years old or greater
- Diagnosis of overactive bladder (urinary urgency or frequency, OAB) or urinary urgency incontinence (UUI)
Exclusion Criteria
- Have a diagnosis of neurogenic bladder
- Received intravesical botox injections within prior 6 months
- Current treatment with either: SNM, PTNS, or OAB medications - need wash out as below
- SNM - turn device off for at least 2 weeks prior to procedure, off during 3-month follow up window
- PTNS - no treatments within 2 weeks of start, none during 3-month post-procedure follow up window
- OAB meds - 2 week wash out period prior to injection, none during 3-month post-procedure follow up window
- Currently pregnant or trying to get pregnant
- Contraindications to Botox® - hypersensitivity to Botox®, inability to self-catheterize/refusal to have indwelling catheter
- Have a UTI (can enroll after treatment)
- Have urinary retention (PVR>150cc on two occasions)
- Do not speak English or Spanish
Data sourced from ClinicalTrials.gov (NCT05308979). 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.