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

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ClinicalTrials.gov Identifier: NCT03033537
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmad Raef Sadek, Adam International Hospital

Brief 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.

Condition or disease Intervention/treatment
Erectile Dysfunction 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction: A Pilot Study
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : January 20, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Verapamil
Intracavernosal injection of Verapamil
Drug: Verapamil
Local treatment of erectile dysfunction
Other Name: 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 Name: Calcium Channel Blocker




Primary Outcome Measures :
  1. IIEF5 [ Time Frame: 6 months ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males complaining of erectile dysfunction
Criteria

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.
Additional Information:

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Responsible Party: Ahmad Raef Sadek, Dr., Adam International Hospital
ClinicalTrials.gov Identifier: NCT03033537    
Other Study ID Numbers: 2016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Verapamil
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents