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

NCT ID: NCT03554070

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-09-01

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.

Conditions

Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infravesical Obstruction

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

Group Type: EXPERIMENTAL

Thulium Fiber Laser Enucleation of the Prostate

Intervention Type: 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.

Thulium Fiber Laser "Urolase"

Intervention Type: 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.

Interventions

Thulium Fiber Laser Enucleation of the Prostate

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.

Intervention Type: PROCEDURE

Thulium Fiber Laser "Urolase"

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dmitry Enikeev, MD, PhD

Deputy Director for Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dmitry Enikeev

Role: STUDY_DIRECTOR

I.M. Sechenov First Moscow State Medical University

Locations

Clinic of Urology, I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 29430969 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28497447 (View on PubMed)

Other Identifiers

Sechenov-ThuFLEP18

Identifier Type: -

Identifier Source: org_study_id