High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH
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|ClinicalTrials.gov Identifier: NCT03264482|
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : October 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Procedure: M-TURP Procedure: THUVAP||Not Applicable|
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and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.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|
|Intervention Model:||Parallel Assignment|
|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|
Active Comparator: THUVAP
vaporization of prostatic adenoma via THULIUM laser
Active Comparator: M-TURP
monopolar transurethral resection
endoscopic resection of the prostatic adenoma
- IPSS score at 12 months . [ Time Frame: 12 months ]international prostate symptom score (both voiding & storage symptom subscores )
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 ClinicalTrials.gov identifier (NCT number): NCT03264482
|Contact: Ahmed M. Shoma, Professoremail@example.com|
|Contact: Ahmed M. Elshal, Lecturerfirstname.lastname@example.org|
|Urology and nephrology center||Recruiting|
|Al Manşūrah, DK, Egypt, 35516|
|Contact: Ahmed M Elshal, MD +20502202222 ext 1643 email@example.com|
|Principal Investigator:||Ahmed M. Elshal, MD||Mansoura University|