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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03264482
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

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.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Procedure: M-TURP Procedure: THUVAP

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and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Benign Prostatic Hyperplasia: High Power Thulium Laser Front Fire Vaporization VS Transurethral Resection - A Randomized Controlled Trial
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Thulium
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: THUVAP
thulium vaporization
Procedure: THUVAP
vaporization of prostatic adenoma via THULIUM laser
Active Comparator: M-TURP
monopolar transurethral resection
Procedure: M-TURP
endoscopic resection of the prostatic adenoma

Primary Outcome Measures :
  1. IPSS score at 12 months . [ Time Frame: 12 months ]
    international prostate symptom score (both voiding & storage symptom subscores )

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03264482

Contact: Ahmed M. Shoma, Professor 01223766818
Contact: Ahmed M. Elshal, Lecturer 01001855490

Urology and nephrology center Recruiting
Al Manşūrah, DK, Egypt, 35516
Contact: Ahmed M Elshal, MD    +20502202222 ext 1643   
Sponsors and Collaborators
Mansoura University
Principal Investigator: Ahmed M. Elshal, MD Mansoura University

Responsible Party: Ahmed Elshal, Dr, Mansoura University Identifier: NCT03264482     History of Changes
Other Study ID Numbers: THUVAP VS M-TURP
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male