Low Power ThULEP for Prostate Size More Than 80 gm

August 9, 2022 updated by: Samer Morsy, Kasr El Aini Hospital

Low Power Thulium Enucleation of Prostate More Than 80 Grams

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intra operative outcome and postoperative follow up of IPSS score and IEFF score at 6 months.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12334
        • Samer Morsy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurogenic patients
  • stricture urethra

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ThuLEP group
Procedure: ThuLEP
Minimal invasive prostate intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Timing of complete adenoma removal ( enucleation time in minutes)
Time Frame: During operation
During operation
International prostate symptoms score IPSS less than 7 which is good outcome
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
International Index of Erectile Function- 5 score more than 12 which is a good outcome
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urology department

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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