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

NCT04164355 | Completed

• 1 other identifier: PT1515/19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomy

  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

  Six months

Study Arms (2)

Patients undergoing Tadalafil

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

Drug: Tadalafil 20 MG

Control Group

Healthy controls without previous surgery of radical prostatectomy.

Interventions

Tadalafil 20 MG DRUG

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy

Also known as: Cialis

Patients undergoing Tadalafil

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 45 years with diagnosis of erectile dysfunction due to surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil and they have not other ophthalmological disease and diabetes.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Interventions

Tadalafil

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Gilda Cennamo

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 15, 2019
• Study Start: July 4, 2020
• Primary Completion: April 25, 2021
• Study Completion: April 30, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

IT (1)