Back to resultsLow Power ThULEP for Prostate Size More Than 80 gm
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ThuLEP
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- BPH patients with failed medical treatment
- Refractory retention
- Hematuria
- Bladder stones
- Renal impairment due to BPH
Exclusion Criteria:
- Neurogenic patients
- stricture urethra
Sites / Locations
- Samer Morsy
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ThuLEP group
Arm Description
Outcomes
Primary Outcome Measures
Timing of complete adenoma removal ( enucleation time in minutes)
International prostate symptoms score IPSS less than 7 which is good outcome
Secondary Outcome Measures
International Index of Erectile Function- 5 score more than 12 which is a good outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05494944
Brief Title
Low Power ThULEP for Prostate Size More Than 80 gm
Official Title
Low Power Thulium Enucleation of Prostate More Than 80 Grams
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
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
5. Study Description
Brief Summary
Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams
Detailed Description
Intra operative outcome and postoperative follow up of IPSS score and IEFF score at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ThuLEP group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
ThuLEP
Intervention Description
Minimal invasive prostate intervention
Primary Outcome Measure Information:
Title
Timing of complete adenoma removal ( enucleation time in minutes)
Time Frame
During operation
Title
International prostate symptoms score IPSS less than 7 which is good outcome
Time Frame
12 months
Secondary Outcome Measure Information:
Title
International Index of Erectile Function- 5 score more than 12 which is a good outcome
Time Frame
12 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BPH patients with failed medical treatment
Refractory retention
Hematuria
Bladder stones
Renal impairment due to BPH
Exclusion Criteria:
Neurogenic patients
stricture urethra
Facility Information:
Facility Name
Samer Morsy
City
Cairo
ZIP/Postal Code
12334
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Low Power ThULEP for Prostate Size More Than 80 gm
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