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NCT05494944 Clinical Trial

Low Power ThULEP for Prostate Size More Than 80 gm

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Low Power Thulium Enucleation of Prostate More Than 80 Grams

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05494944
Other study ID # Urology department
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date March 30, 2022

Study information
Verified date August 2022
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ThuLEP
Minimal invasive prostate intervention

Locations
Country Name City State
Egypt Samer Morsy Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Timing of complete adenoma removal ( enucleation time in minutes) During operation
Primary International prostate symptoms score IPSS less than 7 which is good outcome 12 months
Secondary International Index of Erectile Function- 5 score more than 12 which is a good outcome 12 months
See also
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