Plain English Summary
Background and study aims
Benign prostatic hyperplasia is a condition affecting older men where the prostate becomes enlarged. This can cause difficulties in urination, a desire to urinate frequently and difficulty in fully emptying the bladder. It is usually treated by surgery which involves cutting away a section of the prostate gland in a procedure called transurethral resection of the prostate TURP). In this study, we are going to compare a new procedure, Thulium Laser Prostatectomy (ThuLEP) with the gold standard treatment, TURP, and a traditional treatment called Open Simple Prostatectomy (OSP).
Who can participate?
Participants that are eligible for surgical treatment of benign prostatic hyperplasia
What does the study involve?
All participants undergo an extensive evaluation before surgery which includes urodynamic study, evaluation of symptoms, quality of life and erectlie function. These are evaluated again in the follow-up period after surgery. Participants are randomised to either undergo ThuLEP or TURP surgery. Information on OSP cases are collected over a period of time.
What are the possible benefits and risks of participating?
The use of the currently most advanced 200W Thulium laser device (Revolix 200, Lisa laser products OHG, Katlenburg-Lindau, Germany) may prove of benefit for the patients.
Where is the study run from?
Department of Urology, University of Patras (Greece)
When is the study starting and how long is it expected to run for?
December 2013 to December 2016
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Professor Evangelos Liatsikos
Comparative evaluation of the surgical outcome Thulium laser (200W) enucleation of the prostate: Comparative assessment with transurethral resection of the prostate and open simple prostatectomy.
Improvement of symptoms, maximum flow and complication profile of the Thulium laser enucleation (ThuLEP) in comparison to the transurethral resectionof the prostate (TURP) and the open simple prostatectomy (OSP).
Scientific Board of University Hospital of Patras, Rion, Patras, Greece, 02/12/2013, ref: 5921/19-3-2014
Randomized comparison of surgical treatments for benign prostatic hyperplasia
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Benign prostatic hyperplasia, benign bladder outlet obstruction, urology
1. Randomization arm 1: Thulium laser enucleation (ThuLEP)
2. Randomization arm 2: Transurethral Resection of the Prostate (TURP)
Prospective data collection of consecutive cases: Open Simple Prostatectomy (OSP)
Primary outcome measures
1. Symptoms (International Prostate Symptom Score, I-PSS), measured pre-operatively, at 1 month, at 3 months and at 12 months
2. Maximum flow rate: Urodynamic evaluation, measured pre-operatively and at 3 months
3. Time for catheter removal
4. Erectile function (International Index of Erectile Function Questionnaire, IIEF) at 1 month, 3 months and 12 months
5. Complications during first month after surgery and at 12 months
Secondary outcome measures
Overall trial start date
Overall trial end date
Participant inclusion criteria
Candidates for surgical treatment of Benign Prostatoc Hyperplasia (BPH):
1. Prostate volume >60ml
2. Qmax <15ml/s
3. Post-void residual (PVR) <150ml
4. Insufficient conservative or pharmacological treatment of BPH
5. Urodynamic confirmation of bladder outlet obstruction
Target number of participants
Participant exclusion criteria
1. Prostate volume <60ml
2. Qmax >15ml/s
3. Post-void residual (PVR) >150ml
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital of Patras
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Our intention is to publish in international journals and as abstracts in congresses the results obtained by the study.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting