Transperineal Laser Ablation Of Prostate Versus Transurethral Prostate Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Hyperplasia
- Sponsor
- San Carlo di Nancy Hospital
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Change in Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Riccardo Bertolo
Assistant Professor
San Carlo di Nancy Hospital
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in Visual Analogue Scale (VAS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Changes in International Prostate Symptom Score (IPSS)(Differences among preoperative status versus 1, 3, 6, 12 months after surgery)
- Changes in Quality of Life (QoL)(Differences among preoperative status versus 1, 3, 6, 12 months after surgery)
- Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)(Differences among preoperative status versus 1, 3, 6, 12 months after surgery)