Safety and Efficacy of MILEP Versus Standard EEP | NCT06839768

Studies
Safety and Efficacy of MILEP Versus Standard EEP

NCT06839768

Sponsor

Sechenov University

Status

Recruiting

Last Update Posted

Feb 21, 2025Actual

Enrollment

340Estimated

Phase

Not Applicable

Conditions

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

Interventions

Standard endoscopic enucleation of the prostate (EEP)
MiLEP

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2024Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

May 2025Estimated

First Submitted Date

Jan 13, 2025

First Submission Date that Met QC Criteria

Feb 17, 2025

First Posted Date

Feb 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2025

Last Update Posted Date

Feb 21, 2025Actual

Name	Class
Hospital Pompeia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

340Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MiLEP (22 Ch)	Experimental		Procedure: MiLEP
EEP (26 Ch)	Active Comparator		Procedure: Standard endoscopic enucleation of the prostate (EEP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of SUI		1 month

Secondary Outcomes

Measure	Description	Time Frame
Rate of urethral strictures		6-12 months
Rate of intra- and perioperative adverse events	Assessed using Clavien-Dindo classification system	the day of operation, at 1, 6,12 months post-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vladislav Petov, Associate Professor, urologist	Contact	+7 925 351 75 49		pettow@mail.ru

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Urology and Reproductive Health, Sechenov University	Recruiting	Moscow		119435.	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia
D059411	Lower Urinary Tract Symptoms

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided