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

I.M. Sechenov First Moscow State Medical University

Status: Unknown

Conditions: Prostatic Hyperplasia

Treatments: Device: Thulium Fiber Laser "Urolase"; Procedure: Thulium Fiber Laser Enucleation of the Prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT03554070

Sechenov-ThuFLEP18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Infravesical Obstruction

Experimental group

Description:

Patients with infravesical obstruction due to BPH (IPSS \> 20, Qmax \< 10), who underwent Thulium Fiber Laser Enucleation of the Prostate.

Treatment:

Device: Thulium Fiber Laser "Urolase"

Procedure: Thulium Fiber Laser Enucleation of the Prostate