Clinical Outcomes of Laser Prostatectomy

NCT03318991 | Unknown DMC

• 1 other identifier: NTCH17001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Benign prostate obstruction (BPO) can be treated with a range of laser treatments using different laser systems and applications. Transurethral laser treatment is considered to be an alternative treatment to transurethral resection of the prostate (TURP). The latest guidelines of the European Association of Urology recommend 532-nm GreenLight laser vaporisation of the prostate and thulium laser enucleation as alternatives to TURP. For further investigation of the efficacy of GreenLight and thulium laser in treating BPH, the investigators organize a prospective randomised control study. The investigators will enrol 100 patients with BPO, treated with either GreenLight laser or thulium laser prostatectomy, and compare their safety and efficacy.

Conditions

Prostatic Hypertrophy

Keywords

thulium laser; GreenLight laser; laser therapy; resection of the prostate; prostate hyperplasia

Outcome Measures

Primary Outcomes (1)

• IPSS at 1 year

  The primary outcome measurement is International Prostate Symptom Score (IPSS) at 1 year. The minimum and maximum scores are 0 and 35. The higher score means worse symptoms.

  1 year

Secondary Outcomes (2)

• Maximal flow rate (Qmax)

  1 year

• Quality-of-life questionnaire

  1 year

Study Arms (2)

GreenLight laser

ACTIVE COMPARATOR

180W Greenlight laser is used for vaporesection of the prostate.

Procedure: Laser prostatectomy

Thulium laser

ACTIVE COMPARATOR

200W Thulium laser is used for enucleation of the prostate.

Procedure: Laser prostatectomy

Interventions

Laser prostatectomy PROCEDURE

Patients with symptomatic benign prostate obstruction (BPO) will be assigned under randomisation to treat with GreenLight laser or thulium laser.

GreenLight laser; Thulium laser

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

New Taipei City Hospital

New Taipei City, Taiwan

Location

Related Publications (4)

• Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.

  PMID: 24972732 RESULT

• Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.

  PMID: 26283011 RESULT

• Netsch C, Becker B, Tiburtius C, Moritz C, Becci AV, Herrmann TRW, Gross AJ. A prospective, randomized trial comparing thulium vapoenucleation with holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic obstruction: perioperative safety and efficacy. World J Urol. 2017 Dec;35(12):1913-1921. doi: 10.1007/s00345-017-2071-z. Epub 2017 Jul 11.

  PMID: 28698991 RESULT

• Zhao C, Yang H, Chen Z, Ye Z. Thulium Laser Resection Versus Plasmakinetic Resection of Prostates in the Treatment of Benign Prostate Hyperplasia: A Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2016 Oct;26(10):789-798. doi: 10.1089/lap.2016.0044. Epub 2016 Aug 8.

  PMID: 27500451 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student, Graduate Institute of Clinical Medicine

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 24, 2017
• Study Start: October 1, 2017
• Primary Completion: October 19, 2018
• Study Completion: November 30, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)