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

NCT05415865 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-09-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    lead OTHER

  • Region Hovedstadens Apotek

    collaborator OTHER_GOV

Principal Investigators

  • Niels Klarskov, Prof,MD,DMSc · Herlev and Gentofte Hospital, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2024-04-01
Completion
2024-05-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415865 on ClinicalTrials.gov