Research Directory Details | National Medical Research Register

Cross-cultural adaptation and validation of the English version of the International Index of Erectile Function (IIEF) for use in Malaysia

Cross-cultural adaptation and validation of the English version of the International Index of Erectile Function (IIEF) for use in Malaysia

Validation IIEF

General Information
Research Type
Observational
Description
Validation of Questionnaire
Study Information
RMK Priority Area
Research Level
Research Keyword
validation
questionnaires
cross cultural adaptation
Inclusion & Exclusion Criteria
Inclusion Criteria
The community sample must satisfy the following criteria:
1. Verbal informed consent.
2. Pass the ‘Language Test’ to verify fluency in written Bahasa Malaysia. Subject will be asked to read aloud a paragraph written in Bahasa Malaysia and then interpret the paragraph.
3. Male sex and age > 40 years
4. Recruited from a community setting. Possible setting include public health forum, public health screening program.
All patients for the clinical sample must satisfy the following criteria:
1. Verbal informed consent.
2. Have diabetes mellitus, hypertension or renal failure, and on treatment and follow-up at participating investigational sites.
3. Pass the ‘Language Test’ to verify fluency in written Bahasa Malaysia. Subject will be asked to read aloud a paragraph written in Bahasa Malaysia and then interpret the paragraph.
4. Male sex and age > 40 years
Exclusion criteria:
1. Participation in any drug trial in which the patient received Sildenafil within 30 days or 5 half-lives (whichever is longer) preceding the screening phase of this study.
2. Known allergy or hypersensitivity to drugs similar to Sildenafil
3. Current diagnosis of severe cardiovascular disease.
4. Known drug or alcohol dependence.
5. History of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol.
6. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
Exclusion Criteria
The community sample must satisfy the following criteria:
1. Verbal informed consent.
2. Pass the ‘Language Test’ to verify fluency in written Bahasa Malaysia. Subject will be asked to read aloud a paragraph written in Bahasa Malaysia and then interpret the paragraph.
3. Male sex and age > 40 years
4. Recruited from a community setting. Possible setting include public health forum, public health screening program.
All patients for the clinical sample must satisfy the following criteria:
1. Verbal informed consent.
2. Have diabetes mellitus, hypertension or renal failure, and on treatment and follow-up at participating investigational sites.
3. Pass the ‘Language Test’ to verify fluency in written Bahasa Malaysia. Subject will be asked to read aloud a paragraph written in Bahasa Malaysia and then interpret the paragraph.
4. Male sex and age > 40 years
Exclusion criteria:
1. Participation in any drug trial in which the patient received Sildenafil within 30 days or 5 half-lives (whichever is longer) preceding the screening phase of this study.
2. Known allergy or hypersensitivity to drugs similar to Sildenafil
3. Current diagnosis of severe cardiovascular disease.
4. Known drug or alcohol dependence.
5. History of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol.
6. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Oct, 01 2001
Expected / Actual Date Study Completed
Jul, 18 2002
Expected / Actual Duration of Study Enrollment / Data Collection
41 weeks