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

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03554070
Collaborator
(none)
500
Enrollment
1
Location
1
Arm
42.1
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thulium Fiber Laser Enucleation of the Prostate
  • Device: Thulium Fiber Laser "Urolase"
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline IPSS at 1,3 and 6 months [baseline and at 1,3 and 6 months]

    International Prostate Symptom Score

  2. 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

  1. Change from Baseline QoL at 1,3 and 6 months [baseline and at 1,3 and 6 months]

    Quality of Life (IPSS-QoL scale)

  2. Change from Baseline IIEF-5 at 3 and 6 months [baseline and at 3 and 6 months]

    The International Index of Erectile Function - 5

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinic of Urology, I.M. Sechenov First Moscow State Medical University Moscow Russian Federation 119991

Sponsors and Collaborators

  • I.M. Sechenov First Moscow State Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dmitry Enikeev, MD, PhD, Deputy Director for Science, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier:
NCT03554070
Other Study ID Numbers:
  • Sechenov-ThuFLEP18
First Posted:
Jun 12, 2018
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dmitry Enikeev, MD, PhD, Deputy Director for Science, I.M. Sechenov First Moscow State Medical University
Prostate
BPH
Laser
Endoscopic Enucleation of the Prostate
Thulium
Thulium Fiber Laser
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia

Study Results

No Results Posted as of Jul 22, 2021