Clinical Trials Directory

Trials / Completed

CompletedNCT03264482

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

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and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historical reference-standard procedures for prostate size between 30-80 ml for years.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

Interventions

TypeNameDescription
PROCEDUREM-TURPendoscopic resection of the prostatic adenoma
PROCEDURETHUVAPvaporization of prostatic adenoma via THULIUM laser

Timeline

Start date
2017-05-20
Primary completion
2018-12-02
Completion
2020-12-01
First posted
2017-08-29
Last updated
2021-07-27

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03264482. Inclusion in this directory is not an endorsement.