Clinical trial NCT04781049: Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial
Official title: Transperineal Laser Ablation Of Prostate Versus Transurethral Prostate Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Hyperplasia
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Benign Prostatic Hypertrophy With Outflow Obstruction
Keywords: TPLA
TURP
BPH
BPO
LUTS
Lead sponsor: San Carlo di Nancy Hospital
Sponsor class: OTHER
Collaborators: name: Elesta S.R.L.
First posted: 2021-03-04
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS)
timeFrame: Differences between preoperative and 4-hours postoperative
measure: Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (EJ-MSHQ)
timeFrame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
measure: Changes in Sexual function as assessed by the International Index of Erectile Function Questionnaire (IIEF)
timeFrame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Secondary outcomes:
measure: Changes in International Prostate Symptom Score (IPSS)
timeFrame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
measure: Changes in Quality of Life (QoL)
timeFrame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
measure: Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)
timeFrame: Differences among preoperative status versus 1, 3, 6, 12 months after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Carlo di Nancy Hospital
state: RM
Study officials:
affiliation: San Carlo di Nancy Hospital
name: Pierluigi Bove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
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 Urol. 2011 Apr;29(2):179-84. doi: 10.1007/s00345-010-0605-8. Epub 2010 Oct 21.
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 2014 Aug 16.
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 Health (BACH) Survey. Arch Intern Med. 2006 Nov 27;166(21):2381-7. doi: 10.1001/archinte.166.21.2381.
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.
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;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
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.
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):722-30. doi: 10.1111/j.1464-410X.2011.10512.x. Epub 2011 Aug 22.
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: 10.1016/j.eururo.2014.10.031. Epub 2014 Nov 15.
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 Jul;80(1):95-103. doi: 10.1016/j.eururo.2020.08.018. Epub 2020 Aug 28.