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

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Verapamil

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Males complaining of erectile dysfunction

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Verapamil; Intracavernosal injection of Verapamil	Drug: Verapamil; Local treatment of erectile dysfunction; Other Names: Calcium Channel Blocker
Phentolamine; Intracavernosal injection of Phentolamine to treat erectile dysfunction for a period of 2 wweks	Drug: Verapamil; Local treatment of erectile dysfunction; Other Names: Calcium Channel Blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF5	Questionnaire	6 months

Collaborators and Investigators

• Sponsor: Adam International Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 20, 2016

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Verapamil; Calcium Channel Blockers
• Other Study ID Numbers: 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No