An interventional study of Trans-Perineal Laser Ablation of Prostate and Trans-Urethral Resection of Prostate in Prostate Hyperplasia, Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, sponsored by San Carlo di Nancy Hospital. Completed at 1 site in Italy. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by San Carlo di Nancy Hospital · Not applicable, Interventional, and Treatment
The primary objective of the study is to compare Trans-Perineal Laser Ablation of Prostate versus Trans-Urethral Resection of Prostate in the immediate impact on post-operative pain; in terms of relief in benign prostatic obstruction and preservation of the ejaculatory function in the short term (at 1, 3 and 6 months).
The secondary objective of the study is the evaluation of the long-term deobstructive effectiveness (12 months).
Consecutive patients coming to our institution affected by benign prostatic obstruction (BPO) with indication to surgery and strong need of ejaculatory preservation will be enrolled in the present randomised controlled trial study after counseling. After an informed consent is obtained, uroflowmetry with calculation of the post-voiding residual volume (PVR), a transrectal ultrasonography to estimate prostate volume (PVol), the international prostate symptoms score (IPSS) questionnaire with quality of life (QoL) assessment, and the evaluation of the ejaculatory sexual function will be performed in all patients.
Trans-Perineal Laser Ablation of Prostate (TPLA) will be performed using the EchoLaser combined system (Elesta, Italy).
During the procedure, two 21G spinal needles are inserted transperineally in the peri-urethral area under ultrasound-guidance. By optical fibers, a maximum energy of 1800 J at a power of 3 Watts is delivered. If necessary, the fibers are eventually pulled-back. Immediately after the procedure, the patients will be asked to fill in the Visual Analogue Scale (VAS) for the assessment of the pain perceived. Perioperative data and postoperative data including assessment of ejaculatory function will be analyzed at different time points.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 51 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →San Carlo di Nancy Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who undergo Trans-Perineal Laser Ablation of Prostate
Procedure: Trans-Perineal Laser Ablation of Prostate
Participants who undergo the standard treatment, namely Trans-Urethral Resection of Prostate
Procedure: Trans-Urethral Resection of Prostate
TPLA treatment will be performed using the EchoLaser EVO system (Elesta SpA - Calenzano, FI, Italy). EchoLaser EVO consists of four echolasers, a multi-source laser system with a wavelength of 1064nm and Echolaser Smart Interface (ESI), a treatment planning device for safely inserting introductor needles and optical fibers into prostate tissue. EchoLaser therapy is a micro-invasive percutaneous procedure that uses laser light transmitted through applicators (optical fibers) for a few minutes, causing a heating of the affected tissue to its irreversible damage in "situ", without the need to remove it. EchoLaser therapy, through flat-tip fibers, produces an ellipsoidal clotting area (area where the tissue has irreversible damage). EchoLaser therapy will be performed under ultrasound guidance.
TURP is the gold standard for the treatment of benign prostatic obstruction. It will be performed by using a bipolar energy resectoscope. The procedure will be carried out with patient in a lithotomic position.
Change in Visual Analogue Scale (VAS)
Visual Analogue Scale. A standardized assessment of perceived pain. Scaled from a minimum of 0 to a maximum of 10 points.
Time frame: Differences between preoperative and 4-hours postoperative
Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (EJ-MSHQ)
EJ-MSHQ questionnaire will be used for a standardized assessment. Scaled from a minimum of 0 to a maximum of 25 points.
Time frame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Changes in Sexual function as assessed by the International Index of Erectile Function Questionnaire (IIEF)
IIEF questionnaire will be used for a standardized assessment. Scaled from a minimum of 0 to a maximum of 25 points.
Time frame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Changes in International Prostate Symptom Score (IPSS)
Standardized Evaluation of the relief in prostate symptoms score. Scaled from a minimum of 0 to a maximum of 35 points.
Time frame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Changes in Quality of Life (QoL)
Standardized Evaluation of the improvement in Quality of Life. Scaled from a minimum of 0 to a maximum of 6 points.
Time frame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)
objective improvement of maximum urinary flow rate at uroflowmetry. Measured in ml/s, scaled from 0 to the maximum of the distribution (usually no more than 50 ml/s)
Time frame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Plan to share: No — The study will be subject of publication. The data will be available upon request.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Carlo di Nancy Hospital