Low Power ThULEP for Prostate Size More Than 80 gm

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05494944
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 27.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Procedure: ThuLEP	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Low Power Thulium Enucleation of Prostate More Than 80 Grams
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Mar 30, 2022
• Actual Study Completion Date: Mar 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Timing of complete adenoma removal ( enucleation time in minutes) [During operation]

2. International prostate symptoms score IPSS less than 7 which is good outcome [12 months]

Secondary Outcome Measures

1. International Index of Erectile Function- 5 score more than 12 which is a good outcome [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BPH patients with failed medical treatment

• Refractory retention

• Hematuria

• Bladder stones

• Renal impairment due to BPH

Exclusion Criteria:

• Neurogenic patients

• stricture urethra

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samer Morsy	Cairo		Egypt	12334

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samer Morsy, Lecturer, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT05494944
• Other Study ID Numbers: Urology department
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Aug 12, 2022