Comparative evaluation of the surgical outcome Thulium laser enucleation of the prostate
| ISRCTN | ISRCTN72879639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72879639 |
| Secondary identifying numbers | 5921/19-3-2014 |
- 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
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
Contact information
Public
University of Hospital of Patras
Department of Urology
Rion
Patras
26504
Greece
Study information
| Study design | Randomized comparison of surgical treatments for benign prostatic hyperplasia |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 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(s) | Scientific Board of University Hospital of Patras, Rion, Patras, Greece, 02/12/2013, ref: 5921/19-3-2014 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 02/12/2013 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 90 |
| 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 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
Study participating centre
Patras
26504
Greece
Sponsor information
Other
Department of Urology
Rion
Patras
26504
Greece
"ROR" |
https://ror.org/03c3d1v10 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Our intention is to publish in international journals and as abstracts in congresses the results obtained by the study. |
| 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 |
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.
