Prostatic Hyperplasia
Conditions
Keywords
Prostate, BPH, Laser, Endoscopic Enucleation of the Prostate, Thulium, Thulium Fiber Laser
Brief summary
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).
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Men aged 18 or older * Infravesical obstruction due to prostatic hyperplasia (IPSS \> 20 or Qmax \<10)
Exclusion criteria
* Participation in another clinical study * Prostate cancer (pathology confirmed) * Urinary tract infection * Neurogenic bladder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline IPSS at 1,3 and 6 months | baseline and at 1,3 and 6 months | International Prostate Symptom Score |
| Change from Baseline Qmax at 1,3 and 6 months | baseline and at 1,3 and 6 months | Maximal urinary flow rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline QoL at 1,3 and 6 months | baseline and at 1,3 and 6 months | Quality of Life (IPSS-QoL scale) |
| Change from Baseline IIEF-5 at 3 and 6 months | baseline and at 3 and 6 months | The International Index of Erectile Function - 5 |
| Change from Baseline Prostate Volume at 1,3 and 6 months | baseline and at 1,3 and 6 months | Prostate volume measured by ultrasound (transrectal or abdominal) |
Countries
Russia