search
Back to results

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

Primary Purpose

Prostatic Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Thulium Fiber Laser Enucleation of the Prostate
Thulium Fiber Laser "Urolase"
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring Prostate, BPH, Laser, Endoscopic Enucleation of the Prostate, Thulium, Thulium Fiber Laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infravesical Obstruction

Arm Description

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

Outcomes

Primary Outcome Measures

Change from Baseline IPSS at 1,3 and 6 months
International Prostate Symptom Score
Change from Baseline Qmax at 1,3 and 6 months
Maximal urinary flow rate

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2018
Last Updated
July 21, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03554070
Brief Title
Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Efficacy and Safety
Official Title
Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP): Short-Term Efficacy and Safety Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
Prostate, BPH, Laser, Endoscopic Enucleation of the Prostate, Thulium, Thulium Fiber Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infravesical Obstruction
Arm Type
Experimental
Arm Description
Patients with infravesical obstruction due to BPH (IPSS > 20, Qmax < 10), who underwent Thulium Fiber Laser Enucleation of the Prostate.
Intervention Type
Procedure
Intervention Name(s)
Thulium Fiber Laser Enucleation of the Prostate
Intervention Description
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
Device
Intervention Name(s)
Thulium Fiber Laser "Urolase"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline IPSS at 1,3 and 6 months
Description
International Prostate Symptom Score
Time Frame
baseline and at 1,3 and 6 months
Title
Change from Baseline Qmax at 1,3 and 6 months
Description
Maximal urinary flow rate
Time Frame
baseline and at 1,3 and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline QoL at 1,3 and 6 months
Description
Quality of Life (IPSS-QoL scale)
Time Frame
baseline and at 1,3 and 6 months
Title
Change from Baseline IIEF-5 at 3 and 6 months
Description
The International Index of Erectile Function - 5
Time Frame
baseline and at 3 and 6 months
Title
Change from Baseline Prostate Volume at 1,3 and 6 months
Description
Prostate volume measured by ultrasound (transrectal or abdominal)
Time Frame
baseline and at 1,3 and 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Clinic of Urology, I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29430969
Citation
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.
Results Reference
background
PubMed Identifier
28497447
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs