Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Transperineal Laser Ablation Of Prostate Versus Transurethral Prostate Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781049
• Other study ID #: 1580/CELazio1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: February 2023
• Source: San Carlo di Nancy Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 6, 2022
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• Benign Prostatic Hypertrophy With Outflow Obstruction
• Hyperplasia
• Hypertrophy
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Trans-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.
• Trans-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.

Locations

Country	Name	City	State
Italy	San Carlo di Nancy Hospital	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
San Carlo di Nancy Hospital	Elesta S.R.L.

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the — View Citation

Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov; — View Citation

Biester K, Skipka G, Jahn R, Buchberger B, Rohde V, Lange S. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int. 2012 Mar;109(5):722-3 — View Citation

de Rienzo G, Lorusso A, Minafra P, Zingarelli M, Papapicco G, Lucarelli G, Battaglia M, Ditonno P. Transperineal interstitial laser ablation of the prostate, a novel option for minimally invasive treatment of benign prostatic obstruction. Eur Urol. 2021 J — View Citation

Gacci M, Corona G, Vignozzi L, Salvi M, Serni S, De Nunzio C, Tubaro A, Oelke M, Carini M, Maggi M. Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis. BJU Int. 2015 Jan;115(1):24-31. doi: 10.1111/bju.12728. Epub 20 — View Citation

Kupelian V, Wei JT, O'Leary MP, Kusek JW, Litman HJ, Link CL, McKinlay JB; BACH Survery Investigators. Prevalence of lower urinary tract symptoms and effect on quality of life in a racially and ethnically diverse random sample: the Boston Area Community H — View Citation

Martin SA, Haren MT, Marshall VR, Lange K, Wittert GA; Members of the Florey Adelaide Male Ageing Study. Prevalence and factors associated with uncomplicated storage and voiding lower urinary tract symptoms in community-dwelling Australian men. World J Ur — View Citation

Parsons JK. Benign Prostatic Hyperplasia and Male Lower Urinary Tract Symptoms: Epidemiology and Risk Factors. Curr Bladder Dysfunct Rep. 2010 Dec;5(4):212-218. doi: 10.1007/s11884-010-0067-2. Epub 2010 Sep 7. — View Citation

Perera M, Roberts MJ, Doi SA, Bolton D. Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systematic review and meta-analysis. Eur Urol. 2015 Apr;67(4):704-13. doi: 10. — View Citation

Siroky MB, Olsson CA, Krane RJ. The flow rate nomogram: II. Clinical correlation. J Urol. 1980 Feb;123(2):208-10. doi: 10.1016/s0022-5347(17)55859-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Differences between preoperative and 4-hours postoperative
Primary	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.	Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Primary	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.	Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Secondary	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.	Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Secondary	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.	Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Secondary	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)	Differences among preoperative status versus 1, 3, 6, 12 months after surgery