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

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



Sponsors


Source

I.M. Sechenov First Moscow State Medical University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Active, not recruiting

Start Date

2018-03-01

Completion Date

2020-09-01

Primary Completion Date

2020-03-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change from Baseline IPSS at 1,3 and 6 months
baseline and at 1,3 and 6 months
Change from Baseline Qmax at 1,3 and 6 months
baseline and at 1,3 and 6 months

Secondary Outcome

Measure

Time Frame

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

Enrollment

500

Condition


Intervention

Intervention Type

Procedure

Intervention Name


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.

Arm Group Label

Infravesical Obstruction


Intervention Type

Device

Intervention Name


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.

Arm Group Label

Infravesical Obstruction



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

Gender

Male

Gender Based

Yes

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

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

Location

Facility

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

Location Countries

Country

Russian Federation


Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

I.M. Sechenov First Moscow State Medical University

Investigator Full Name

Dmitry Enikeev, MD, PhD

Investigator Title

Deputy Director for Science


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Infravesical Obstruction

Arm Group Type

Experimental

Description

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


Firstreceived Results Date

N/A

Reference

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.

PMID

29430969


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.

PMID

28497447



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

May 17, 2018

Study First Submitted Qc

May 30, 2018

Study First Posted

June 12, 2018

Last Update Submitted

May 30, 2018

Last Update Submitted Qc

May 30, 2018

Last Update Posted

June 12, 2018


ClinicalTrials.gov processed this data on June 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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