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

Abertawe Bro Morgannwg University LHB0 个研究点开始时间: 2010年7月6日最近更新: 2013年5月20日

适应症

试验速览

暂无简介。

•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

•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

发起方

Abertawe Bro Morgannwg University LHB