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

NCT04781049 | Completed DMC

• 1 other identifier: 1580/CELazio1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

TPLA; TURP; BPH; BPO; LUTS

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• 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

Study Arms (2)

TPLA (Trans-Perineal Laser Ablation of Prostate)

EXPERIMENTAL

Participants who undergo Trans-Perineal Laser Ablation of Prostate

Procedure: Trans-Perineal Laser Ablation of Prostate

TURP (Trans-Urethral Resection of Prostate)

ACTIVE COMPARATOR

Participants who undergo the standard treatment, namely Trans-Urethral Resection of Prostate

Procedure: Trans-Urethral Resection of Prostate

Interventions

Trans-Perineal Laser Ablation of Prostate PROCEDURE

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.

TPLA (Trans-Perineal Laser Ablation of Prostate)

Trans-Urethral Resection of Prostate PROCEDURE

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.

TURP (Trans-Urethral Resection of Prostate)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: The study is investigating a novel micro-invasive treatment for benign prostatic obstruction. Thus, being male and having prostate in situ is mandatory.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• San Carlo di Nancy Hospital: lead
• Elesta S.R.L.: collaborator

Study Sites (1)

San Carlo di Nancy Hospital

Roma, RM, 00175, Italy

Location

Related Publications (11)

• 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.

  PMID: 12559262 RESULT

• 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.

  PMID: 20963421 RESULT

• 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.

  PMID: 24602293 RESULT

• 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.

  PMID: 17130393 RESULT

• 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.

  PMID: 21475707 RESULT

• 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.

  PMID: 1279218 RESULT

• 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.

  PMID: 7354519 RESULT

• 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.

  PMID: 21883855 RESULT

• 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.

  PMID: 25466940 RESULT

• 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.

  PMID: 32868137 RESULT

• Bertolo R, Iacovelli V, Cipriani C, Carilli M, Vittori M, Antonucci M, Maiorino F, Signoretti M, Petta F, Travaglia S, Panei M, Bove P. Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial. BJU Int. 2023 Jul;132(1):100-108. doi: 10.1111/bju.16008. Epub 2023 Mar 30.

  PMID: 36917033 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pierluigi Bove, MD

  San Carlo di Nancy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 4, 2021
• Study Start: January 1, 2021
• Primary Completion: September 20, 2021
• Study Completion: October 6, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)