Transurethral high power (80W) potassium-titanyl-phosphase (KTP) laser vapourisation of the prostate compared with holmium laser ablation of the prostate: a single-centre randomised controlled trial in patients with obst. benign prostatic hyperplasia

ISRCTN	ISRCTN14776501
DOI	https://doi.org/10.1186/ISRCTN14776501
Protocol serial number	N0355178146
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Funder	Mid Essex Hospital Services NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Ranjan Thilagarajah
Scientific

Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom

Phone	+44 (0)1245 514021

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine which of the currently used energy delivery systems in laser prostatectomy provides for the most durable clinical outcomes.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Prostatectomy
Intervention	Patients will be invited to participate in the study from the out-patient clinic at the time a decision for surgical intervention has been made. They will have 2-3 weeks to consider whether or not they wish to participate and those electing to join the study will be asked to contact the Clinical Nurse Specialist for formal enrolment and randomization. All patients will be given appropriate information leaflets outlining the aims of the study. Patients electing to join the study will not undergo any further or additional investigations over and above that which is currently regarded as standard or routine practice within the department. The only variable they will submit themselves to is the formal randomization to a particular treatment arm.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Improvements in flow rates and a reduction in IPSS scores
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2007

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	80
Key inclusion criteria	All patients will undergo routine assessment to include uroflowmetry, prostate size assessment, PSA testing and an IPSS score. Those between the ages of 55-75 and have Qmax flow rates of <15 ml/sec and an IPSS score of > 12 (moderate-severe LUTS) and have PSA measurements within the normal range will be eligible for the study. Patients with prostate volumes of between 40-120 cc will be deemed suitable for laser ablation surgery.
Key exclusion criteria	Patients with prostate volumes of greater than 120 cc may require open surgery and those with prostate volumes of < 40 cc may simply require bladder neck incision and are therefore exclusion criteria. Patients presenting with chronic urinary retention will be excluded from the study. These patients may have atonic bladders and voiding difficulties following the procedure may be more difficult to interpret for the purposes of the study.
Date of first enrolment	01/11/2005
Date of final enrolment	01/05/2007

Mid Essex Hospital Services NHS Trust (BH)

Chelmsford
CM1 7ET
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan