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

NCT ID: NCT03264482

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2020-12-01

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.

Detailed Description

When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.

Over the past decade, New minimally invasive surgical therapies (MIST), new medications, and novel combinations of medical therapies have expanded the number of treatment options ranging from watchful waiting to open surgery. The range of treatment options is as broad as the BPH spectrum of symptoms.

These treatment options include prostate vaporization, resection and enucleation using various energy sources , however the main theme for all these new procedures that they were done using physiological saline as an irrigant nullifying the risk of TUR syndrome.

One of the biggest changes in surgical treatment of BPH over the past 2 decades has been the introduction and use of lasers. Two-micron (Thulium) continuous-wave (CW) laser may have several advantages, including sufficient homeostasis with minimal thermal injury, more precise tissue incision, and operation in CW/pulsed modes. Pieces of the prostate are vaporized small enough to evacuate through the resectoscope sheath and use of a mechanical tissue morcellator is not required.

The introduction of the latest generation of the Thulium laser namely "200w laser " raises the expectations of the prostate vaporization.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

THUVAP

thulium vaporization

Group Type: ACTIVE_COMPARATOR

THUVAP

Intervention Type: PROCEDURE

vaporization of prostatic adenoma via THULIUM laser

M-TURP

monopolar transurethral resection

Group Type: ACTIVE_COMPARATOR

M-TURP

Intervention Type: PROCEDURE

endoscopic resection of the prostatic adenoma

Interventions

M-TURP

endoscopic resection of the prostatic adenoma

Intervention Type: PROCEDURE

THUVAP

vaporization of prostatic adenoma via THULIUM laser

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elshal

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M. Elshal, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Urology and nephrology center

Al Manşūrah, DK, Egypt

Countries

Egypt

Other Identifiers

THUVAP VS M-TURP

Identifier Type: -

Identifier Source: org_study_id