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Intravesical Lidocaine for Pain Relief During BTX-A Injections
NCT05415865Phase 3
Key facts
- Status
- Unknown
- Start
- Sep 2022
- Primary completion
- Apr 2024
- Countries
- 1
- Sponsor
- Herlev & Gentofte Hospital
- Modality
- Small Molecules
- Drugs
- lidocaine
- Conditions
- procedural pain
01
Overview
Phase 3, randomised, double-blind trial of lidocaine in procedural pain (2 arms), sponsored by Herlev & Gentofte Hospital. Primary endpoint: Visual Analogue Scale. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Alkalinized Lidocaine then Placebo
Participants receive lidocaine in the first period and placebo in the second period after washout.
Placebo then Alkalinized Lidocaine
Participants receive placebo in the first period and lidocaine in the second period after washout.
03
Who it enrols
Adult females with urgency urinary incontinence scheduled for BTX-A injections, excluding those with neurological disorders affecting bladder function or certain bladder pathologies.
04
Endpoints
Primary
Visual Analogue Scale
Secondary
Post-void residual requiring Clean Intermittent Catheterization
Urinary tract infection
Hematuria
5-point rating scale
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