Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Efficacy and Safety

Not Applicable

• Conditions: Prostatic Hyperplasia
• Interventions: Procedure: Thulium Fiber Laser Enucleation of the Prostate; Device: Thulium Fiber Laser "Urolase"

• Registration Number: NCT03554070
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infravesical Obstruction	Thulium Fiber Laser Enucleation of the Prostate	Patients with infravesical obstruction due to BPH (IPSS \> 20, Qmax \< 10), who underwent Thulium Fiber Laser Enucleation of the Prostate.
Infravesical Obstruction	Thulium Fiber Laser "Urolase"	Patients with infravesical obstruction due to BPH (IPSS \> 20, Qmax \< 10), who underwent Thulium Fiber Laser Enucleation of the Prostate.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Clinic of Urology, I.M. Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation