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

Federico II University

Status: Completed

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Drug: Tadalafil 20 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04164355

PT1515/19

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Patients undergoing Tadalafil

Description:

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

Treatment:

Drug: Tadalafil 20 MG

Control Group

Description:

Healthy controls without previous surgery of radical prostatectomy.