The aim of our study is to estimate the efficacy, safety and postoperative complications of the thulium fiber laser enucleation of the prostate (ThuFLEP) with Urolase system (NTO IRE-POLUS, Russia).
In all patients, IPSS, Qmax, QoL, prostate volume, and IIEF-5 are measured prior to surgery. For ThuFLEP, we use the Urolase system (NTO IRE-POLUS, Russia) and a 600 mcm fiber. The thulium fiber laser is set with a mean output power of 60 W and energy of 1.5 J. Tissue morcellation is completed with the Piranha Morcellator (Richard Wolf, Germany). At the end of the procedure a 22 French three-way Foley catheter is placed. IPSS, Qmax, QoL, prostate volume are recorded at 1, 3 and 6 months after surgery. IIEF-5 are recorded at 3 and 6 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Thulium laser enucleation of the prostate is performed using the two-lobe or en-bloc techniques. Incision depth is limited to the circular fibers of the prostate capsule. The left lobe is enucleated first, starting at the 5 o'clock position. The endoscope is then introduced counterclockwise at the 2 o'clock position. Next, an incision is made at 12 o'clock and extended to the level of the verumontanum. The incisions at the 12 and 2 o'clock positions are connected, and the left lobe is enucleated into the bladder. The right lobe of the gland is enucleated in a similar manner: the initial incision at 7 o'clock was made clockwise, an 11 o'clock incision is then extended along the capsule to join with the previous cut. The final step is morcellation of hyperplastic nodes.
Urolase system (NTO IRE-POLUS, Russian Federation) is a thulium doped fiber laser. Max. power of 120 W and energy of 8 J. Wavelength - 1,94 µm, incision depth - 0,2 mm.
Clinic of Urology, I.M. Sechenov First Moscow State Medical University
Moscow, Russia
Change from Baseline IPSS at 1,3 and 6 months
International Prostate Symptom Score
Time frame: baseline and at 1,3 and 6 months
Change from Baseline Qmax at 1,3 and 6 months
Maximal urinary flow rate
Time frame: baseline and at 1,3 and 6 months
Change from Baseline QoL at 1,3 and 6 months
Quality of Life (IPSS-QoL scale)
Time frame: baseline and at 1,3 and 6 months
Change from Baseline IIEF-5 at 3 and 6 months
The International Index of Erectile Function - 5
Time frame: baseline and at 3 and 6 months
Change from Baseline Prostate Volume at 1,3 and 6 months
Prostate volume measured by ultrasound (transrectal or abdominal)
Time frame: baseline and at 1,3 and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.