Clinical trial NCT03554070: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Efficacy and Safety
Official title: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Hyperplasia
Keywords: Prostate
BPH
Laser
Endoscopic Enucleation of the Prostate
Thulium
Thulium Fiber Laser
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline IPSS at 1,3 and 6 months
timeFrame: baseline and at 1,3 and 6 months
measure: Change from Baseline Qmax at 1,3 and 6 months
timeFrame: baseline and at 1,3 and 6 months
Secondary outcomes:
measure: Change from Baseline QoL at 1,3 and 6 months
timeFrame: baseline and at 1,3 and 6 months
measure: Change from Baseline IIEF-5 at 3 and 6 months
timeFrame: baseline and at 3 and 6 months
measure: Change from Baseline Prostate Volume at 1,3 and 6 months
timeFrame: baseline and at 1,3 and 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Urology, I.M. Sechenov First Moscow State Medical University
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Dmitry Enikeev
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.