Clinical Outcomes of Laser Prostatectomy

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.

Study Overview

• Status: Unknown
• Conditions: Prostatic Hypertrophy
• Intervention / Treatment: Procedure: Laser prostatectomy

Detailed Description

80 patients with symptomatic benign prostate obstruction (BPO) will be assigned under randomization to treat with GreenLight laser or thulium laser. Randomization is performed by free randomization software.

Inclusion criteria are patient age greater than 50 years, maximum flow rate (Qmax) < 15 ml/second and an International Prostate Symptom Score (IPSS) ≥ 10. The data for the quality-of-life questionnaire (QoL) and transrectal ultrasound measurement of the prostate (TRUS) are obtained preoperatively.

Exclusion criteria are known prostate cancer, bladder cancer, previous transurethral surgery, interstitial cystitis and neurogenic bladder confirmed after urodynamic studies. The use of anticoagulants or platelet aggregation inhibition and urinary retention under catheterization is not a criterion for study exclusion. The local institutional review board committee has approved the study as well as the data analysis.

Sample size The sample size was determined based on an expected mean IPSS of 5.8 ± 2.6 at 1-year followup. The investigators considered a change of deference of IPSS ≤ 2 as an accepted equivalence between the two groups. The sample size was calculated to be at least 21 patients in each group with α=0.05, β=0.80 and a desired statistical power level of 80%. Considering the possibility of patients drop out or lost to followup, 40 patients will be enrolled in each arm. All measurement data will be presented as mean ± standard deviation.

Statistical analysis StataCorp Stata 15 was used for statistical analysis. The Fisher's exact test was applied to compare categorical variables; and the Student's t-test was used to compare quantitative variables between the two treatment groups. A mixed model with random effect and Bonferroni correction was applied to compare IPSS, QoL, Qmax, and PVR between two groups. A two-sided P-value of < 0.05 was considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei, Taiwan
    • New Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Inclusion criteria are patient age greater than 50 years, maximum flow rate (Qmax) < 15 ml/second and an International Prostate Symptom Score (IPSS) ≥ 10.

Exclusion Criteria:

• Exclusion criteria are known prostate cancer, bladder cancer, previous transurethral surgery, interstitial cystitis and neurogenic bladder confirmed after urodynamic studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GreenLight laser; 180W Greenlight laser is used for vaporesection of the prostate.	Procedure: Laser prostatectomy; Patients with symptomatic benign prostate obstruction (BPO) will be assigned under randomisation to treat with GreenLight laser or thulium laser.
Active Comparator: Thulium laser; 200W Thulium laser is used for enucleation of the prostate.	Procedure: Laser prostatectomy; Patients with symptomatic benign prostate obstruction (BPO) will be assigned under randomisation to treat with GreenLight laser or thulium laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal flow rate (Qmax)	Maximal uroflow rate at 1 year, compared with preoperative data	1 year
Quality-of-life questionnaire	QoL score at 1 year, compared with preoperative data; The score ranges from 0 (the best) to 6 (the worst).	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 19, 2018
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 21, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: laser therapy; thulium laser; GreenLight laser; resection of the prostate; prostate hyperplasia
• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy
• Other Study ID Numbers: NTCH17001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No