Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03554070
NCT03554070UnknownNot Applicable

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

I.M. Sechenov First Moscow State Medical University2 sites in 2 countries500 target enrollmentStarted: March 1, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
500
Locations
2
Primary Endpoint
Change from Baseline Qmax at 1,3 and 6 months
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Change from Baseline Qmax at 1,3 and 6 months

Time Frame: baseline and at 1,3 and 6 months

Maximal urinary flow rate

Change from Baseline IPSS at 1,3 and 6 months

Time Frame: baseline and at 1,3 and 6 months

International Prostate Symptom Score

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dmitry Enikeev, MD, PhD

Deputy Director for Science

I.M. Sechenov First Moscow State Medical University

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)Prostate Hyperplasia
NCT04580628Clinique Saint-Hilaire50
Completed
Not Applicable
HoLEP vs mTURP in Management of Benign Prostatic HyperplasiaProstatic Hyperplasia
NCT04561505Ain Shams University60
Recruiting
Not Applicable
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)Benign Prostatic Hyperplasia
NCT04807296Centre hospitalier de l'Université de Montréal (CHUM)100
Unknown
Phase 3
A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder CancerBladder Cancer
NCT02951078Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine172
Unknown
Not Applicable
Outcomes and Complications of Holmium Laser Enucleation of the Prostate in Expert HandsBenign Prostatic Hyperplasia
NCT03583034IRCCS San Raffaele275
Thulium Fiber Laser Enucleation of the... | Clinical Trial