NCT06101576

Brief Summary

This study will be conducted to estimate readmission rate and reasons for readmission after all modalities of endoscopic transurethral surgeries for treatment of BOO secondary to BPH in the last 20 years.

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
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2005

Completed
18.8 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

20 years

First QC Date

October 20, 2023

Last Update Submit

October 20, 2023

Conditions

BPH With Urinary Obstruction

Keywords

BPHTURPLaser prostatectomyBNCHolmium Laser

Outcome Measures

Primary Outcomes (1)

  • The need for post discharge hospital readmission.

    The need for post discharge hospital readmission after surgery.

    90 days

Secondary Outcomes (3)

  • Differences of readmission rates

    90 days

  • Change in the causes of readmission over time.

    20 years

  • Causes and predictors of readmission.

    90 days

Study Arms (4)

Transurethral incision of the prostate (TUIP)

Patients who underwent TUIP using electrocautery or Laser.

Procedure: TUIP

Transurethral resection of the prostate (TURP)

Patients who underwent TURP using monopolar or bipolar electrocautery.

Procedure: TURP

Prostate Vaporization

Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate).

Procedure: Prostate Vaporization

Anatomical endoscopic enucleation of the prostate (AEEP)

Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.

Procedure: AEEP

Interventions

TUIPPROCEDURE

Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam.

Transurethral incision of the prostate (TUIP)
TURPPROCEDURE

Patient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current.

Transurethral resection of the prostate (TURP)
Prostate VaporizationPROCEDURE

Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate).

Prostate Vaporization
AEEPPROCEDURE

Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.

Anatomical endoscopic enucleation of the prostate (AEEP)

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

They will be the subdivided into four groups: Group I: Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam. Group II: Patient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current. Group III: Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate). Group IV: Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.

You may qualify if:

  • Men who underwent transurethral prostatic surgery for BPH causing BOO at Urology and Nephrology Center, Mansoura University, Egypt from Jun. 2005 to Dec. 2024.

You may not qualify if:

  • Patients who underwent TUR tunnelling for prostatic adenocarcinoma.
  • LUTS secondary to neuropathic bladder.
  • Incidentally diagnosed prostate cancer after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed R EL-Nahas, MD

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed R EL-Nahas, MD

CONTACT

+201221136899ar_el_nahas@yahoo.com

Amr W Yehia, MD

CONTACT

+201027383536amrwaei33@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

January 1, 2005

Primary Completion

December 31, 2024

Study Completion

February 1, 2025

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)