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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Thulium Fiber Laser Enucleation of the Prostate
* Device: Thulium Fiber Laser Urolase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infravesical Obstruction<br>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<br>* 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.<br>Device: Thulium Fiber Laser Urolase<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline IPSS at 1,3 and 6 months | International Prostate Symptom Score | baseline and at 1,3 and 6 months | 
| Change from Baseline Qmax at 1,3 and 6 months | Maximal urinary flow rate | baseline and at 1,3 and 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, BPH, Laser, Endoscopic Enucleation of the Prostate, Thulium, Thulium Fiber Laser