Prospective Randomized Trial of Irritative Symptoms Severity Assessment After (HoLEP) Versus ThuFLEP

Study Overview
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Brief Summary
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The investigators hypothesize that the functional outcomes of both techniques are comparable. However, ThuFLEP might increase speed recovery of postoperative irritation and early stress urinary incontinence according to the Questionnaire for Urinary Incontinence Diagnosis (QUID) because of minimal tissue penetration depth of TFL.

Detailed Description
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Thulium fiber laser enucleation of the prostate (ThuFLEP) has already shown the outcomes comparable to OSP with better safety profile (lower blood loss compared to OSP) and shorter hospital stay. TFL has the efficacy and safety proven in comparative trials, being a promising rival for HoLEP. The main features of TFL distinguishing it from Ho:YAG is its wavelength of 1.94 µm (leading to about three-fold increase in water absorption and lesser penetration depth of <0.1 mm vs >0.2 mm in Ho:YAG). With identical average and peak powers of 100 W, the laser does not burst tissues, allowing for clean and precise cutting instead. Conversely, Ho:YAG's average power is about 100 W and its presumable peak power is around 10-15 kW. With such an outburst of energy, each pulse of Ho:YAG creates a large vapor bubble which ruptures the tissue. This may be a possible reason for increased irritative symptoms in early postoperative period after HoLEP comparing to ThuFLEP. But all in all, the probable causes for such postoperative symptoms remain unclear so far, despite the fact that absence of irritation and incontinence is ought to be one quality marker of Pentafecta. According to the idea of high-power impact, probably, decreasing of HoLEP power will mitigate these problems. On the one hand, low-power HoLEP is feasible, safe and effective modality for symptomatic BPO. However, the results remain controversial and there is lack of LP-HoLEP application data nowadays. May be, with another option, for instance OSP or monopolar enucleation, it is possible to solve the issues. But the discussion of the past years demonstrates that the presence of early SUI is not only a problem of EEP, but also underreported in other approaches in relieving BPO secondary to BPH.

Official Title
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Prospective Randomized Trial of Irritative Symptoms Severity Assessment After Holmium Laser Enucleation of the Prostate (HoLEP) Versus Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP).

Conditions
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BPH, Prostate Obstruction

Intervention / Treatment
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* Procedure: Thulium fiber laser enucleation of the prostate
* Procedure: Holmium laser enucleation of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LUTS presence, proven by: IPSS questionnaire (Score >20); OR uroflowmetry result (Qmax <10 ml/s); Exclusion Criteria: Prostate volume > 120 cc Prostate cancer on pathology; Urethral strictures; Bladder calculi; Prior prostate surgery; Neurogenic bladder dysfunction.
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThuFLEP<br>Patients who underwent thulium fiber enucleation of the prostate | Procedure: Thulium fiber laser enucleation of the prostate<br>* enucleation of the BPH according to standard procedure protocol<br>* Other names: ThuFLEP;|
| Active Comparator: HoLEP<br>Patients who underwent holmium laser enucleation of the prostate | Procedure: Holmium laser enucleation of the prostate<br>* enucleation of the BPH according to standard procedure protocol<br>* Other names: HoLEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of urinary incontinence | Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence) | change from 1 week to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of intra- and perioperative adverse events | complications according to Clavien-Dindo classification (higher score means more severe complication) | 6 months follow up | 
| surgery duration | lengths of the procedure | during surgery | 
| hemoglobin drop | decrease of hemoglobin at the first day after surgery comparing to preoperative value | 1 day after surgery | 
| catheter stay | lengths of catheterization | 1 week after surgery | 
| hospitalization length | duration of staying at hospital after the surgery | 1 week after surgery | 
| functional outcomes | IPSS (international prostate symptos score), QoL (quality of life), IIEF-5 (international index of erectile function) questionaries, Qmax | change from 3 to 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEP, HoLEP, ThuFLEP, prostate enucleation