NCT06839768

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 21, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

January 13, 2025

Last Update Submit

February 17, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • The rate of SUI

    1 month

Secondary Outcomes (10)

  • Rate of urethral strictures

    6-12 months

  • Rate of intra- and perioperative adverse events

    the day of operation, at 1, 6,12 months post-operative

  • Operative time

    participants will be followed for the duration of the intervention, an expected average of 1 hour

  • Blood loss (blood levels of haemoglobin and haematocrit)

    1 day before and 1 day after surgery

  • Catheterization time

    participants will be followed for the duration of hospital stay, an expected average of 1,5 days

  • +5 more secondary outcomes

Study Arms (2)

MiLEP (22 Ch)

EXPERIMENTAL
Procedure: MiLEP

EEP (26 Ch)

ACTIVE COMPARATOR
Procedure: Standard endoscopic enucleation of the prostate (EEP)

Interventions

Standard endoscopic enucleation of the prostate (EEP)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.

EEP (26 Ch)
MiLEPPROCEDURE

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.

MiLEP (22 Ch)

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LUTS presence, proven by:
  • IPSS questionnaire (Score \>20);
  • OR uroflowmetry result (Qmax \<10 ml/s);

You may not qualify if:

  • Prostate volume \> 120 cc
  • Prostate cancer on pathology;
  • Urethral strictures;
  • Bladder calculi;
  • Prior prostate surgery;
  • Neurogenic bladder dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University

Moscow, 119435., Russia

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Vladislav Petov, Associate Professor, urologist

CONTACT

+7 925 351 75 49pettow@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosiate Professor, urologist

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 21, 2025

Study Start

March 14, 2024

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

February 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)