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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03554070
Enrollment
500
Registered
2018-06-12
Start date
2018-03-01
Completion date
2021-09-01
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

Prostate, BPH, Laser, Endoscopic Enucleation of the Prostate, Thulium, Thulium Fiber Laser

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.

Interventions

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.

DEVICEThulium 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.

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline IPSS at 1,3 and 6 monthsbaseline and at 1,3 and 6 monthsInternational Prostate Symptom Score
Change from Baseline Qmax at 1,3 and 6 monthsbaseline and at 1,3 and 6 monthsMaximal urinary flow rate

Secondary

MeasureTime frameDescription
Change from Baseline QoL at 1,3 and 6 monthsbaseline and at 1,3 and 6 monthsQuality of Life (IPSS-QoL scale)
Change from Baseline IIEF-5 at 3 and 6 monthsbaseline and at 3 and 6 monthsThe International Index of Erectile Function - 5
Change from Baseline Prostate Volume at 1,3 and 6 monthsbaseline and at 1,3 and 6 monthsProstate volume measured by ultrasound (transrectal or abdominal)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026