NCT05494944

Brief Summary

Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

August 5, 2022

Last Update Submit

August 9, 2022

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Timing of complete adenoma removal ( enucleation time in minutes)

    During operation

  • International prostate symptoms score IPSS less than 7 which is good outcome

    12 months

Secondary Outcomes (1)

  • International Index of Erectile Function- 5 score more than 12 which is a good outcome

    12 months

Study Arms (1)

ThuLEP group

OTHER
Procedure: ThuLEP

Interventions

ThuLEPPROCEDURE

Minimal invasive prostate intervention

ThuLEP group

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BPH patients with failed medical treatment
  • Refractory retention
  • Hematuria
  • Bladder stones
  • Renal impairment due to BPH

You may not qualify if:

  • Neurogenic patients
  • stricture urethra

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samer Morsy

Cairo, 12334, Egypt

Location

Related Publications (1)

  • Morsy S, Kamal I, Meshref A, Abdel-Mohsen M, Abdel-Hakim M, Yehia A. Surgical outcomes of low-power thulium laser enucleation of prostates >80 g. One-year of follow-up. Cent European J Urol. 2023;76(3):193-198. doi: 10.5173/ceju.2023.50. Epub 2023 Jul 12.

    PMID: 38045774DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 10, 2022

Study Start

December 1, 2019

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

EG(1)