Safety and Efficacy of MILEP Versus Standard EEP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2025-05-31

Brief Summary

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Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.

Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).

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Detailed Description

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Conditions

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Benign Prostate Hypertrophy(BPH) LUTS(Lower Urinary Tract Symptoms)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MiLEP (22 Ch)

Group Type EXPERIMENTAL

MiLEP

Intervention Type PROCEDURE

Minimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

EEP (26 Ch)

Group Type ACTIVE_COMPARATOR

Standard endoscopic enucleation of the prostate (EEP)

Intervention Type PROCEDURE

Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

Interventions

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Standard endoscopic enucleation of the prostate (EEP)

Stabdard EEP will be nerformed using 26 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

Intervention Type PROCEDURE

MiLEP

Minimally-invasive laser EEP will be nerformed using 22 Ch resectoscope. Enucleation will be performed using an en bloc no-touch technique with early apical release.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

LUTS presence, proven by:

1. IPSS questionnaire (Score \>20);
2. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No