Condition category
Cancer
Date applied
18/05/2015
Date assigned
25/06/2015
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Professor Evangelos Liatsikos

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5921/19-3-2014

Study information

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.

Acronym

Study hypothesis

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

Scientific Board of University Hospital of Patras, Rion, Patras, Greece, 02/12/2013, ref: 5921/19-3-2014

Study design

Randomized comparison of surgical treatments for benign prostatic hyperplasia

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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 names

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

Treatment cost

Overall trial start date

02/12/2013

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

90

Participant exclusion criteria

1. Prostate volume <60ml
2. Qmax >15ml/s
3. Post-void residual (PVR) >150ml

Recruitment start date

20/03/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Greece

Trial participating centre

University Hospital of Patras
Rion
Patras
26504
Greece

Sponsor information

Organisation

University Hospital of Patras

Sponsor details

Department of Urology
Rion
Patras
26504
Greece

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes