Protocol summary
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Study aim
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1- Evaluation of the effect of sildenafil gel on the improvement of erectile dysfunction before and after treatment
2- Evaluation of the effect of sildenafil tablets on the improvement of erectile dysfunction before and after treatment
3- Evaluation of the effect of platelets and tablets on the improvement of erectile dysfunction before and after treatment
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Design
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Three groups: placebo-sildenafil gel, placebo-gel, sildenafil gel, placebo-placebo gel
Block randomization
Blind randomized clinical trial
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Settings and conduct
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In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group.
setting : Urology clinic of Ali Ebn Abitaleb Hospital in Zahedan
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Participants/Inclusion and exclusion criteria
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Entry criteria: Erectile dysfunction, age 30 to 70 years
Exit criteria: Patients with anatomical problems in the penis, other sexual disorders, spinal cord injuries, heart attack in the past six months, stroke, treatment with mineral nitrates, gastric ulcer, migraine, visual impairment and allergic rhinitis
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Intervention groups
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In the sildenafil gel group, the topical sildenafil gel was given. A placebo tablet is also given to the patient to take an hour before sexual contact.
In the oral pill group, an oral dose of sildenafil is consumed. Also, a placebo gel is placed on the male penis.
In a placebo group, patients will receive a placebo tablet and placebo gel before sexual contact.
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Main outcome variables
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Erection, increasing the IIEF, improving the parameters of the penis color Doppler ultrasonography after sexual stimulation, increasing spouse's satisfaction
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016092429960N1
Registration date:
2016-12-01, 1395/09/11
Registration timing:
registered_while_recruiting
Last update:
2019-11-07, 1398/08/16
Update count:
2
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Registration date
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2016-12-01, 1395/09/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Chemical injuries research center of Baqiatollah University
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Expected recruitment start date
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2016-10-22, 1395/08/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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2016-10-22, 1395/08/01
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Actual recruitment end date
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2018-12-22, 1397/10/01
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Trial completion date
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2018-12-22, 1397/10/01
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Scientific title
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Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction
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Public title
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Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 30 to 70 years
having erectile dysfunction
Exclusion criteria:
Penile anatomic abnormalities
other sexual dysfunctions
spinal cord injuries
Acute myocardial infarction within last 6 months
Cerebrovascular accident
nitrate drug use
Peptic ulcer disease
Migrane
visual disturbances
Allergic rhinitis
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Age
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From 30 years old to 70 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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All patients will be randomized with a blocked randomization technique. The treatment group will be assigned with Excel software and use of Rand Function. Patients will be grouped into four-person groups. Physician and patients are not informed about treatment.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group. Medications with labels A and B are indicated for final analysis and return of results.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-18, 1395/04/28
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Ethics committee reference number
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IR.TUMS.REC.1395.16
Health conditions studied
1
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Description of health condition studied
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Erectile dysfunction
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ICD-10 code
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F52.2,N48.
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ICD-10 code description
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The principal problem in men is erectile dysfunction (difficulty in developing or maintaining an erection suitable for satisfactory intercourse),
Primary outcomes
1
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Description
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Sexual satisfaction of patient
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Timepoint
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before intervention, one month after intervention
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Method of measurement
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International index of erectile function questionnaire (IIEF)
2
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Description
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Sexual satisfaction of patient's sexual partner
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Timepoint
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before intervention, one month after intervention
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Method of measurement
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sexual partner satisfaction questionnaire
3
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Description
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Dorsal penile artery PSV
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Timepoint
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before intervention, two weeks after intervention
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Method of measurement
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Color doppler sonography of the penis
4
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Description
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Dorsal penile vein EDV
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Timepoint
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before intervention, two weeks after intervention
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Method of measurement
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Color doppler sonography of the penis
5
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Description
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Dorsal penile artery RI
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Timepoint
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before intervention, two weeks after intervention
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Method of measurement
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Color doppler sonography of the penis
6
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Description
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Erection quality
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Timepoint
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before intervention, one month after intervention
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Method of measurement
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regidity of the penis during sexual contact based on patient interview
7
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Description
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Erection time
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Timepoint
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before intervention, one month after intervention
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Method of measurement
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The stability of erection before orgasm or ejaculation based on patient interview
Secondary outcomes
1
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Description
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complication
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Timepoint
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during study and one month after intervention
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Method of measurement
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based on patient interview
Intervention groups
1
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Description
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Oral sildenafil pill 50 mg one hour before sexual contact for one month in intervention group
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Category
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Treatment - Drugs
2
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Description
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Topical sildenafil gel which applied half an hour before sexual contact on penis for one month in intervention group
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Category
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Treatment - Drugs
3
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Description
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Placebo Pill and Placebo Gel before sexual contact for one month in control group
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all collected deidentified IPD
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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only available for people working in academic institutions
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Under which criteria data/document could be used
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Data will be available for re-analysis and also for use in meta-analysis
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From where data/document is obtainable
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f-sheybaeem@razi.tums.ac.ir
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What processes are involved for a request to access data/document
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Inform the responsible person via email and after coordination with Dr. Younes Panahi, the data will be available.
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Comments
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