Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Benign Prostatic Hypertrophy With Outflow Obstruction, Prostate Hyperplasia
Conditions
Keywords
TPLA, TURP, BPH, BPO, LUTS
Brief summary
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).
Detailed description
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.
Interventions
PROCEDURETrans-Perineal Laser Ablation 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.
PROCEDURETrans-Urethral Resection of Prostate
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.
Sponsors
Elesta S.R.L.
San Carlo di Nancy Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* signed written informed consent * patient able to complete the Whole protocol * IPSS score ≥ 10 * Maximum urinary flow rate \< 15 ml/sec * Prostate volume at preop. ultrasonography \< 100 mL * normal urinalysis (all of the above)
Exclusion criteria
* former prostate surgery * prostate cancer (history) * urethral stricture (history) * Marion's disease (history) * bladder stones * median obstructive lobe, as defined by a \> 1 cm of prostate abutting in the bladder lumen at ultrasonography * neurological conditions potentially impacting on the bladder voiding (at least one of the above)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) | Differences between preoperative and 4-hours postoperative | Visual Analogue Scale. A standardized assessment of perceived pain. Scaled from a minimum of 0 to a maximum of 10 points. |
| Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (EJ-MSHQ) | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | EJ-MSHQ questionnaire will be used for a standardized assessment. Scaled from a minimum of 0 to a maximum of 25 points. |
| Changes in Sexual function as assessed by the International Index of Erectile Function Questionnaire (IIEF) | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | IIEF questionnaire will be used for a standardized assessment. Scaled from a minimum of 0 to a maximum of 25 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in International Prostate Symptom Score (IPSS) | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | Standardized Evaluation of the relief in prostate symptoms score. Scaled from a minimum of 0 to a maximum of 35 points. |
| Changes in Quality of Life (QoL) | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | Standardized Evaluation of the improvement in Quality of Life. Scaled from a minimum of 0 to a maximum of 6 points. |
| Changes in the maximum urinary flow rate at Uroflowmetry (Qmax) | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | 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) |
Countries
Italy
Outcome results
None listed