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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infravesical Obstruction | Experimental | Patients with infravesical obstruction due to BPH (IPSS > 20, Qmax < 10), who underwent Thulium Fiber Laser Enucleation of the Prostate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thulium Fiber Laser Enucleation of the Prostate | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline IPSS at 1,3 and 6 months | International Prostate Symptom Score | baseline and at 1,3 and 6 months |
| Change from Baseline Qmax at 1,3 and 6 months | Maximal urinary flow rate | baseline and at 1,3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline QoL at 1,3 and 6 months | Quality of Life (IPSS-QoL scale) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dmitry Enikeev | I.M. Sechenov First Moscow State Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Urology, I.M. Sechenov First Moscow State Medical University | Moscow | 119991 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29430969 | Background | Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13. | |
| 28497447 |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Thulium Fiber Laser "Urolase" | Device | 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. |
|
| 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) | baseline and at 1,3 and 6 months |
| Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10. |
| D052801 |
| Male Urogenital Diseases |