Comparative evaluation of the surgical outcome Thulium laser enucleation of the prostate

ISRCTN	ISRCTN72879639
DOI	https://doi.org/10.1186/ISRCTN72879639
Protocol serial number	5921/19-3-2014
Sponsor	University Hospital of Patras
Funder	Investigator initiated and funded

Submission date: 18/05/2015
Registration date: 25/06/2015
Last edited: 26/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Evangelos Liatsikos
Public

University of Hospital of Patras
Department of Urology
Rion
Patras
26504
Greece

Study information

Primary study design	Interventional
Study design	Randomized comparison of surgical treatments for benign prostatic hyperplasia
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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.
Study objectives	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).
Ethics approval(s)	Scientific Board of University Hospital of Patras, Rion, Patras, Greece, 02/12/2013, ref: 5921/19-3-2014
Health condition(s) or problem(s) studied	Benign prostatic hyperplasia, benign bladder outlet obstruction, urology
Intervention	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)
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Treatment cost
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	90
Key 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
Key exclusion criteria	1. Prostate volume <60ml 2. Qmax >15ml/s 3. Post-void residual (PVR) >150ml
Date of first enrolment	20/03/2014
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Greece

Study participating centre

University Hospital of Patras

Rion
Patras
26504
Greece

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/02/2021	26/02/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/02/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.