Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033537
• Other study ID #: 2016
• Status: Completed
• Phase: N/A
• First received: January 20, 2017
• Last updated: January 24, 2017
• Start date: July 1, 2015
• Est. completion date: January 20, 2016

Study information

• Verified date: January 2017
• Source: Adam International Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Introduction: Erectile dysfunction is a common condition with a significant effect on quality of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes the tone of the smooth muscles lining blood vessels, leading to their dilatation.

Description:

Objective: Evaluating the effect of intracavernosal injection of (Papaverine + Verapamil) and comparing it with (Papaverine + Phentolamine) in patients with erectile dysfunction.

Patients and methods: Each one of the 20 erectile dysfunction patients was subjected to intracavernosal injection with (30mg Papaverine + 1mg Phentolamine), where penile duplex & clinical evaluation was carried out followed by a wash out interval of 2 weeks after which each patient was subjected to the exact previous procedures using (30 mg Papaverine + 5 mg Verapamil).

Keywords: Erectile dysfunction - Intracavernosal injection - Penile duplex - Phentolamine - Verapamil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 20, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Married male patients suffering from erectile dysfunction and scheduled for intracavernosal injection.

Exclusion Criteria:

• Responders to PDE5-inhibitors; congenital or acquired penile anomalies; uncontrolled medical conditions or known hypersensitivity to verapamil; Peyronie's disease and any known bleeding or coagulation disorders.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Verapamil
Local treatment of erectile dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adam International Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF5	Questionnaire	6 months