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Completed

NCT Number: NCT03264482

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology and nephrology center

Al Manşūrah, DK, 35516, Egypt

About this study

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and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M-TURP

Procedure

endoscopic resection of the prostatic adenoma

THUVAP

Procedure

vaporization of prostatic adenoma via THULIUM laser

Primary outcomes

  1. IPSS score at 12 months .

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Treatment of Benign Prostatic Hyperplasia: High Power Thulium Laser Front Fire Vaporization VS Transurethral Resection - A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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