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

July 21, 2021 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Clinic of Urology, I.M. Sechenov First Moscow State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infravesical Obstruction
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
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline IPSS at 1,3 and 6 months
Time Frame: baseline and 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
Time Frame: baseline and at 1,3 and 6 months
Maximal urinary flow rate
baseline and at 1,3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline QoL at 1,3 and 6 months
Time Frame: baseline and at 1,3 and 6 months
Quality of Life (IPSS-QoL scale)
baseline and at 1,3 and 6 months
Change from Baseline IIEF-5 at 3 and 6 months
Time Frame: baseline and at 3 and 6 months
The International Index of Erectile Function - 5
baseline and at 3 and 6 months
Change from Baseline Prostate Volume at 1,3 and 6 months
Time Frame: baseline and at 1,3 and 6 months
Prostate volume measured by ultrasound (transrectal or abdominal)
baseline and at 1,3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Study Director: Dmitry Enikeev, I.M. Sechenov First Moscow State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

July 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sechenov-ThuFLEP18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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