NCT04342533

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 12, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

March 12, 2020

Last Update Submit

July 21, 2021

Conditions

BPHProstate Obstruction

Keywords

HoLEPThuFLEPEEPprostate enucleation

Outcome Measures

Primary Outcomes (1)

  • severity of urinary incontinence

    Questionnaire for Urinary Incontinence Diagnosis (higher score means worse incontinence)

    change from 1 week to 6 months after surgery

Secondary Outcomes (6)

  • rate of intra- and perioperative adverse events

    6 months follow up

  • surgery duration

    during surgery

  • hemoglobin drop

    1 day after surgery

  • catheter stay

    1 week after surgery

  • hospitalization length

    1 week after surgery

  • +1 more secondary outcomes

Study Arms (2)

ThuFLEP

EXPERIMENTAL

Patients who underwent thulium fiber enucleation of the prostate

Procedure: Thulium fiber laser enucleation of the prostate

HoLEP

ACTIVE COMPARATOR

Patients who underwent holmium laser enucleation of the prostate

Procedure: Holmium laser enucleation of the prostate

Interventions

Thulium fiber laser enucleation of the prostatePROCEDURE

enucleation of the BPH according to standard procedure protocol

Also known as: ThuFLEP
ThuFLEP
Holmium laser enucleation of the prostatePROCEDURE

enucleation of the BPH according to standard procedure protocol

Also known as: HoLEP
HoLEP

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailspresence of prostate and BPH
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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, 119991, Russia

Location

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
Deputy director for research

Study Record Dates

First Submitted

March 12, 2020

First Posted

April 13, 2020

Study Start

April 1, 2020

Primary Completion

July 10, 2021

Study Completion

October 10, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)