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

NCT03554070 | Unknown

• 1 other identifier: Sechenov-ThuFLEP18
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostatic Hyperplasia

Keywords

Prostate; BPH; Laser; Endoscopic Enucleation of the Prostate; Thulium; Thulium Fiber Laser

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Change from Baseline QoL at 1,3 and 6 months

  baseline and at 1,3 and 6 months

• Change from Baseline IIEF-5 at 3 and 6 months

  baseline and at 3 and 6 months

• Change from Baseline Prostate Volume at 1,3 and 6 months

  baseline and at 1,3 and 6 months

Study Arms (1)

Infravesical Obstruction

EXPERIMENTAL

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

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

Interventions

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.

Infravesical Obstruction

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.

Infravesical Obstruction

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 18 or older
• Infravesical obstruction due to prostatic hyperplasia (IPSS \> 20 or Qmax \<10)

You may not qualify if:

• Participation in another clinical study
• Prostate cancer (pathology confirmed)
• Urinary tract infection
• Neurogenic bladder

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, 119991, Russia

Location

Related Publications (2)

• 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.

  PMID: 29430969 BACKGROUND

• 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.

  PMID: 28497447 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dmitry Enikeev

  I.M. Sechenov First Moscow State Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Science

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 12, 2018
• Study Start: March 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

RU (1)