A study to compare the effectiveness and morbidity of Alkalinized Intravesical Lidocaine Vs Lidocaine gel in achieving anaesthesia prior to intravesical Botulinum Toxin (BTX) injections

Conditions: The aim of this randomised study is to compare the effectiveness and morbidity of alkalinized intravesical Lidocaine Vs Lidocaine gel in achieving adequate anaesthesia prior to intravesical injections of Botulinum Toxin (BTX).

Registration Number: EUCTR2010-018611-15-GB

Lead Sponsor: Abertawe Bro Morgannwg University LHB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Patients admitted for intravesical Botulinum Toxin A (BTX) injections under flexible cystoscopy guidance
•Written informed consent to be obtained

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients < 18 years of age
•Patients having the procedure under General Anaesthetic
•Proven bladder outflow obstruction
•Neurological disease that may affect bladder function/sensation.
•Patients with urethral catheters or practising Intermittent self catheterisation
•Serious concomitant illness
•Significant Cardiovascular disease
•History of Cardiac arrhythmia or any cardiac conduction disorder
•Liver disease
•Bleeding disorders
•Patients with Supra-pubic or long term urethral catheters
•Pregnant or breast feeding patients
•Acute urinary tract infection
•Any other bladder pathology at the time of cystoscopy (includes trauma, stones, tumour)
•Patients with active genital infection, other than genital warts.
•Male patients with previous or current history of prostate cancer
•Patients with known allergy or sensitivity to any component of the study medication, anaesthetics or antibiotics to be used during the study
•Patient is participating in any other study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main outcome measure will be the difference in the mean visual analogue scale for pain;Secondary Objective: Safety/Adverse Events;Primary end point(s): The main end point study outcome measure will be the difference in the mean visual analogue pain score between groups

Secondary Outcome Measures