The effect of bladder installed local anesthetic solution 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000559-38-DK

Enrollment

Registered

2021-11-17

Start date

2022-07-02

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of intravesical Lidocaine solution versus placebo on pain perception during intravesical injection of Onabotulinum toxin A. MedDRA version: 21.1 Level: LLT Classification code 10046495 Term: Urge incontinence syndrome System Organ Class: 100000004857 MedDRA version: 21.1 Level: LLT Classification code 10002321 Term: Anesthesia System Organ Class: 100000004852

Interventions

Trade Name: Lidokain SAD Pharmaceutical Form: Injection INN or Proposed INN: Lidokain Other descriptive name: LIDOCAINE HYDROCHLORIDE PHEUR Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
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. 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 ;Timepoint(s) of evaluation of this end point: 2021-2024	—

Measure

Time frame

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. 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 ;Timepoint(s) of evaluation of this end point: 2021-2024

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Secondary

Measure	Time frame
Secondary end point(s): Perform onabotulinum toxin A injections in outpatient clinics ;Timepoint(s) of evaluation of this end point: 2021-2024	—

Countries

Denmark

Contacts

Public ContactDepartment of Gynecology and Obstet

Department of Gynecology and Obstetrics, Herle and Gentofte University Hospital

Meryam.el.issaoui.01@regionh.dk+4553252379

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026