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).
Conditions
Interventions
Trade Name: Sodium Bicarbonate Injection BP Minijet 8.4% w/v. Solution for injection
Product Name: Sodium Bicarbonate Injection BP Minijet 8.4% w/v. Solution for injection
Product Code: PA 255/1/4
Pha
Sponsors
Abertawe Bro Morgannwg University LHB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed