High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH

NCT03264482 | Completed DMC

• 1 other identifier: THUVAP VS M-TURP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a prospective randomized trial.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• IPSS score at 12 months .

  international prostate symptom score (both voiding \& storage symptom subscores )

  12 months

Study Arms (2)

THUVAP

ACTIVE COMPARATOR

thulium vaporization

Procedure: THUVAP

M-TURP

ACTIVE COMPARATOR

monopolar transurethral resection

Procedure: M-TURP

Interventions

M-TURP PROCEDURE

endoscopic resection of the prostatic adenoma

M-TURP

THUVAP PROCEDURE

vaporization of prostatic adenoma via THULIUM laser

THUVAP

Eligibility Criteria

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

You may qualify if:

• Patients' age ≥50 years
• LUTS secondary to BOO due to BPH who failed medical treatment
• International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
• Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
• ASA (American society of anaesthesiologists) score ≤3.
• TRUS prostate size between 30-80 ml

You may not qualify if:

• Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
• Active urinary tract infection,
• Presence of active bladder pathology (within the last 2 years)
• Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
• Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
• Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
• Patient has had an acute myocardial infarction or open-heart surgery \<180 days prior to the date of informed consent

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Manşūrah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed M. Elshal, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

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: Dr

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 29, 2017
• Study Start: May 20, 2017
• Primary Completion: December 2, 2018
• Study Completion: December 1, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

EG (1)