Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

Completed

• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Drug: Tadalafil 20 MG

• Registration Number: NCT04164355
• Lead Sponsor: Federico II University

Brief Summary

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.

Detailed Description

Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.

This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.

The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography parameters at baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Study Start: 2020-07-04
• Primary Completion: 2021-04-25
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• age older than 45 years
• diagnosis of erectile dysfunction due to surgery of radical prostatectomy
• treatment-naïve with Tadalafil for erectile dysfunction
• absence of vitreoretinal and vascular retinal diseases
• absence of diabetes

Exclusion Criteria

• age younger than 45 years
• diagnosis of erectile dysfunction due to other causes
• previous treatments before Tadalafil for erectile dysfunction
• presence of vitreoretinal and vascular retinal diseases
• presence of diabetes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing Tadalafil	Tadalafil 20 MG	Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for 6 months

Primary Outcome Measures

Name	Time	Method
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomy	Six months	Changes in retinal and choriocapilary vessel density in 40 patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy