The effect of bladder installed local anesthetic solution prior to Botox injections in the bladder

Phase 1

Conditions: The effect of intravesical Lidocaine solution versus placebo on pain perception during intravesical injection of Onabotulinum toxin A.
MedDRA version: 21.1Level: LLTClassification code 10046495Term: Urge incontinence syndromeSystem Organ Class: 100000004857
MedDRA version: 21.1Level: LLTClassification code 10002321Term: AnesthesiaSystem Organ Class: 100000004852
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2021-000559-38-DK

Lead Sponsor: Herlev and Gentofte University Hospital, Department of Obstetrics and Gynecology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 50

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 injection as an outpatient treatment without the option of receiving sedative drugs

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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)
•Positive urine culture and symptoms of urinary tract infection prior to treatment
•Any other bladder pathology at the time of cystoscopy if identified (includes trauma, stones, tu-mor)
•Pregnancy/breastfeeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to investigate the effect of lidocaine-solution versus placebo (isotonic NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onabotulinum toxin A injections in the treatment of urgency urinary incontinence.<br>Primary outcome is the maximum pain score reported by using the 100 mm visual analogue scale (VAS) immediately after the injection procedure. ;Secondary Objective: Secondary outcome is adverse events: Post-void residual requiring clean intermittent catherization (CIC), signs of urinary tract infection (UTI), hematuria, patient’s satisfaction on a 5-point scale. ;Primary end point(s): Primary end point is to reduce discomfort associated with onabotulinum toxin A injections and<br><br>;Timepoint(s) of evaluation of this end point: 2021-2024

Secondary Outcome Measures