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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2015/08/006096 |
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Date of registration:
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13-08-2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sildenafil versus Papaverine in the diagnosis of male erectile dysfunction
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Scientific title:
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Sildenafil as an alternative to Papaverine for the diagnostic evaluation of erectile dysfunction (ED) with penile doppler ultrasonography (PDUS) |
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Date of first enrolment:
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12-02-2014 |
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Target sample size:
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60 |
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Recruitment status: |
Closed to Recruitment of Participants |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12252 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Amit Kumar
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Address:
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Department of Surgery
University College of Medical Sciences University of Delhi GTB Hospital Delhi 95 Department of Surgery
University College of Medical Sciences University of Delhi GTB Hospital Delhi 95
110095
North East, DELHI
India |
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Telephone:
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22586262 |
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Email:
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dramitkr12@gmail.com |
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Affiliation:
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Dept of Surgery OPD |
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Name:
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Dr Amit Kumar
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Address:
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Department of Surgery
University College of Medical Sciences University of Delhi GTB Hospital Delhi 95 Department of Surgery
University College of Medical Sciences University of Delhi GTB Hospital Delhi 95
110095
North East, DELHI
India |
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Telephone:
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22586262 |
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Email:
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dramitkr12@gmail.com |
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Affiliation:
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Dept of Surgery OPD |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 All patients aged greater than or equal to 18 years giving informed consent to participate in the study.
2 At least a 3 months prior history of erectile dysfunction.
3 International Index of Erectile Function-5 (IIEF-5)13 scores <21.
Exclusion criteria: 1. Patients not willing for consent for inclusion in the above study.
2. Patients on Sildenafil citrate therapy within last two weeks.
3.Patients with known contraindications for PDE5-Is such as poor cardiac performance, severe ischemia, coagulation defects, recent myocardial infarction and patients on nitrate therapy.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Erectile Dysfunction
Health Condition 2: N529- Male erectile dysfunction, unspecified
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Intervention(s)
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Intervention1: S-Group: One Tablet of Sildenafil Citrate 100mg administered with a glass of water about one hour prior to penile doppler ultrasonography in patients of ED.
Control Intervention1: P-Group: Intracavernosal injection of Papaverine hydrochloride given in both the corpora at dose of 30-60 mgs (depending on the clinical response) given two minutes prior to penile doppler ultrasonography under aseptic precautions.
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Primary Outcome(s)
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PSV above 30cms-1 EDV below 5cms-1 and or RI below 0.8 for penile arterial insufficiency.
EDV above 5cms (or RI below 0.8) for penile venogenic dysfunction.
Clinical erection hardness score (E1-E4)for ED in general.Timepoint: 5,10,15,20,25,30,35,40,45 minutes.
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Secondary Outcome(s)
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NoneTimepoint: None
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Secondary ID(s)
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IEC-HR/UCMS/27.11.2013
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Source(s) of Monetary Support
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None
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Ethics review
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Status: Approved
Approval date: 27/11/2013
Contact:
Institutional Ethics Committee (EC)-HUMAN RESEARCH(IEC-HR),
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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