NCT05415865

The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder

The Effect of Intravesical Lidocaine Solution Versus Placebo as Anesthesia Prior to Intravesical Injection of Onabotulinum Toxin A. A Randomized, Double-blind, Placebo Controlled Cross-over Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of Lidocaine solution versus placebo (isotonic Sodium Chloride NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onabotulinum toxin A injections in the treatment of urgency urinary incontinence.

Detailed description

The aim of the study is to investigate if bladder installed Lidocaine solution have an effect on reported pain during BTX-A injections compared to placebo. The study participants will be recruited from the existing patient populations enrolled in the BTX-A program of the tertiary Urogynaecological Clinic of Herlev University Hospital. The participants are randomized to: 1. Active drug: Lidocaine Hydrochloride and Sodium hydrogen carbonate 2. Placebo: Sodium Chloride The study includes 5 study visits: Visit 1: * First treatment day * Randomization * Registration of pre-treatment pain relief medications: paracetamol, ibuprofen, or other medications. If pre-treatment pain relief is taken before first treatment, same pain relief should be taken before second treatment day (visit 4) in order to reduce bias * Registration of antibiotic treatment: current antibiotic treatment or long-term prophylactic antibiotic for prevention of recurrent UTI The participant receives the active treatment or placebo, double-blinded * The participant is asked to grade the intensity of pain according to VAS score immediately after, and when participant has been dressed after the BTX-A injections Visit 2 (by telephone): * Phone consultation 1 week after treatment: * The participant's experience on the procedure on a 5-point ordinal scale: "1- very unsatisfied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied" Side effects: * Questions on symptoms of UTI: dysuria, cloudy urine, pollakiuria, nocturia * Hematuria * Inability to empty the bladder * Other symptoms (Visit 3:) * The participant contacts the Clinic for next treatment approximately 6-12 months later * Sponsor or investigator from the Urogynecological Clinic reach out for the participant asking on symptoms of UUI if the participant has not contacted the clinic within 12 months Visit 4: * Second treatment day * The participant receives the opposite treatment, still double-blinded * Registration of pre-treatment pain relief medications: paracetamol, ibuprofen, or other medications * Registration of antibiotic treatment: current antibiotic treatment or long-term prophylactic antibiotic for prevention of recurrent UTI * The participant is asked to grade the intensity of pain according to VAS score immediately after, and when participant has been dressed after the BTX-A injections Visit 5(by telephone): * Phone consultation 1 week after treatment: * The participant's experience on the procedure on a 5-point scale: "1- very unsatisfied", "2- unsatisfied", "3- neither unsatisfied or satisfied", "4- satisfied", "5-very satisfied" Side effects: * Questions on symptoms of UTI: dysuria, cloudy urine, pollakiuria nocturia, * Hematuria * Inability to empty the bladder * Other symptoms

Conditions

• Urge Incontinence
• Overactive Bladder
• Anesthesia, Local
• Pain, Procedural
• Urinary Tract Infections
• Hematuria

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Alkalinized Lidocaine	20 ml of Lidocaine Hydrochloride and 10 ml of Sodium hydrogen carbonate will be pulled up and mixed in a syringe on site, and 30 ml mixed solution in total will afterwards be installed in the bladder with a catheter.
DRUG	Placebo Sodium Chloride 0.9% Inj	20 ml of Sodium Chloride 9 g/L and 10 ml of Sodium Chloride 9 g/L will be pulled up and mixed in a syringe on site, and 30 ml solution in total will afterwards be installed in the bladder with a catheter.

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-04-01
• Completion: 2024-05-01
• First posted: 2022-06-13
• Last updated: 2022-09-22

Locations

1 site across 1 country: Denmark