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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herlev and Gentofte Hospital
• Collaborator: Region Hovedstadens Apotek
• Treatments: Lidocaine

Criteria

Inclusion criteria:

• Female, age ≥18 years

• Admitted to treatment with BTX-A injections at the Urogynecological Clinic at Herlev Hospital due to UUI

• Able to read and understand Danish

• The female accepts to receive BTX-A injections as an outpatient treatment without the option of receiving sedative drugs

Exclusion criteria:

• BTX-A allergy

• Neurological disorder that may affect bladder function (e.g. Multiple sclerosis or spinal cord inju-ry)

• Neurological disorder with neuromuscular transmission failure (i.e. Mystenia Gravis)

• Ongoing UTI or symptoms of UTI prior to treatment, assessed by principal investigator

• Any other bladder pathology at the time of cystoscopy if identified (includes trauma, stones, tu-mor)

• Pregnancy/breastfeeding women