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Protocol - Male Sexual Function

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Description:

The participant answers whether he has had difficulty with erections and sexual function during the past 4 weeks.

Protocol:

1. How often did you have difficulty with any of the following?

A. Achieving an erection

[ ] 1 Almost never

[ ] 2 Sometimes

[ ] 3 Often

[ ] 4 Almost always

B. Ejaculating too early

[ ] 1 Almost never

[ ] 2 Sometimes

[ ] 3 Often

[ ] 4 Almost always

C. Difficulty ejaculating

[ ] 1 Almost never

[ ] 2 Sometimes

[ ] 3 Often

[ ] 4 Almost always

D. Lack of interest in sex

[ ] 1 Almost never

[ ] 2 Sometimes

[ ] 3 Often

[ ] 4 Almost always

2. Over the past four weeks how often were you able to get an erection during sexual activity?

[ ] 0 No sexual activity

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

3. Over the past four weeks when you had erections with sexual stimulation, how often were your erections hard enough for penetration?

[ ] 0 No sexual activity

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

4. Over the past four weeks when you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?

[ ] 0 Did not attempt intercourse

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

5. Over the past four weeks during sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?

[ ] 0 Did not attempt intercourse

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

6. Over the past four weeks during sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?

[ ] 0 Did not attempt intercourse

[ ] 1 Extremely difficult

[ ] 2 Very difficult

[ ] 3 Difficult

[ ] 4 Slightly difficult

[ ] 5 Not difficult

7. Over the past four weeks how many times have you attempted sexual intercourse?

[ ] 0 No attempts

[ ] 1 One or two attempts

[ ] 2 Three to four attempts

[ ] 3 Five to six attempts

[ ] 4 Seven to ten attempts

[ ] 5 Eleven+ attempts

8. Over the past four weeks when you attempted sexual intercourse, how often was it satisfactory for you?

[ ] 0 Did not attempt intercourse

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

9. Over the past four weeks how much have you enjoyed sexual intercourse?

[ ] 0 No intercourse

[ ] 1 No enjoyment

[ ] 2 Not very enjoyable

[ ] 3 Fairly enjoyable

[ ] 4 Highly enjoyable

[ ] 5 Very highly enjoyable

10. Over the past four weeks when you had sexual stimulation or intercourse, how often did you ejaculate?

[ ] 0 No sexual stimulation/intercourse

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

11. Over the past four weeks when you had sexual stimulation or intercourse, how often did you have the feeling of orgasm or climax?

[ ] 0 No sexual stimulation/intercourse

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

12. Over the past four weeks how often have you felt sexual desire?

[ ] 1 Almost never/never

[ ] 2 A few times (much less than half the time)

[ ] 3 Sometimes (about half the time)

[ ] 4 Most times (much more than half the time)

[ ] 5 Almost always/always

13. Over the past four weeks how would you rate your level of sexual desire?

[ ] 1 Very low/none at all

[ ] 2 Low

[ ] 3 Moderate

[ ] 4 High

[ ] 5 Very high

14. Over the past four weeks how satisfied have you been with your overall sex life?

[ ] 1 Very dissatisfied

[ ] 2 Moderately dissatisfied

[ ] 3 About equally satisfied and dissatisfied

[ ] 4 Moderately satisfied

[ ] 5 Very satisfied

15. Over the past four weeks how satisfied have you been with your sexual relationship with your partner?

[ ] 1 Very dissatisfied

[ ] 2 Moderately dissatisfied

[ ] 3 About equally satisfied and dissatisfied

[ ] 4 Moderately satisfied

[ ] 5 Very satisfied

16. Over the past four weeks, how do you rate your confidence that you could get and keep an erection?

[ ] 1 Very low

[ ] 2 Low

[ ] 3 Moderate

[ ] 4 High

[ ] 5 Very high

Protocol Name from Source:

Study for Future Families and International Index of Erectile Function (IIEF)

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs

Pencil and paper

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Self-administered questionnaire

Life Stage:

Adult

Participants:

Adult males 18 years and older

Swan et al. (2003) sample included males 18-53 (question 1).

Rosen et al. (1997) sample included males 18 and older with a clinical diagnosis of erectile dysfunction (questions 2-16).

Specific Instructions:

Note: At the recommendation of the PhenX Reproductive Health Working Group, the response categories in questions 1A-1D have been reversed from the original questions.

Note: These questions reference the past 4 weeks.

Selection Rationale

The Rosen questionnaire is the standard questionnaire currently used by researchers in the field of male sexual function. Question 1 adds additional important information.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Male Sexual Function 3007476 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Male sexual func proto 62666-3 LOINC
Process and Review

The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.

Guidance from ERP 5 includes:

  • Revised descriptions of the measure

Back-compatible; no changes to Data Dictionary.

Previous version in Toolkit archive (link).

Source

Rosen, R. C., Riley, A., Wagner, G., Osterloh, I. H., Kirkpatrick, J., & Mishra, A. (1997). The International Index of Erectile Dysfunction (IIEF): A multidimensional scale for the assessment of erectile dysfunction. Urology, 49(6), 822-830. Questions 2-16.

Swan, S. H., Brazil, C., Drobnis, E. Z., Liu, F., Kruse, R. L., Hatch, M., . . . Overstreet, J. W.; Study for Future Families Group. (2003). Geographic differences in semen quality of fertile U.S. males. Environmental Health Perspectives, 111(4), 414-420. Question number 16 (question 1); utilizes question from Study for Future Families.

General References

Berner, M. M., Kriston, L., & Harms, A. (2006). Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations. International Journal of Impotence Research, 18(3), 229-235.

Protocol ID:

101001

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX101001_Attempt_Sexual_Intercourse_Satisfactory PX101001080000 Over the past four weeks when you attempted sexual intercourse, how often was it satisfactory for you? 4 N/A
PX101001_Attempt_Sexual_Intercourse_Times PX101001070000 Over the past four weeks how many times have you attempted sexual intercourse? 4 N/A
PX101001_Confidence_Get_Keep_Erection PX101001160000 Over the past four weeks how do you rate your confidence that you could get and keep an erection? 4 N/A
PX101001_Difficulty_Achieving_Erection PX101001010100 How often did you have difficulty with Achieving an erection? 4 N/A
PX101001_Difficulty_Ejaculating PX101001010300 How often did you have difficulty with Difficulty ejaculating? 4 N/A
PX101001_Difficulty_Ejaculating_Early PX101001010200 How often did you have difficulty with Ejaculating too early? 4 N/A
PX101001_Difficulty_Lack_Interest_Sex PX101001010400 How often did you have difficulty with Lack of interest in sex? 4 N/A
PX101001_Enjoy_Sexual_Intercourse PX101001090000 Over the past four weeks how much have you enjoyed sexual intercourse? 4 N/A
PX101001_Erection_During_Sexual_Activity PX101001020000 Over the past four weeks how often were you able to get an erection during sexual activity? 4 N/A
PX101001_Erection_Hard_Enough_Penetration PX101001030000 Over the past four weeks when you had erections with sexual stimulation, how often were your erections hard enough for penetration? 4 N/A
PX101001_Maintain_Erection_After_Penetrated PX101001050000 Over the past four weeks during sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? 4 N/A
PX101001_Maintain_Erection_Completion_Intercourse PX101001060000 Over the past four weeks during sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? 4 N/A
PX101001_Overall_Sex_Life_Satisfied PX101001140000 Over the past four weeks how satisfied have you been with your overall sex life? 4 N/A
PX101001_Penetrate_Sexual_Intercourse PX101001040000 Over the past four weeks when you attempted sexual intercourse, how often were you able to penetrate (enter) your partner? 4 N/A
PX101001_Sexual_Desire_Felt PX101001120000 Over the past four weeks how often have you felt sexual desire? 4 N/A
PX101001_Sexual_Desire_Level_Rate PX101001130000 Over the past four weeks how would you rate your level of sexual desire? 4 N/A
PX101001_Sexual_Stimulation_Intercourse_Ejaculate PX101001100000 Over the past four weeks when you had sexual stimulation or intercourse, how often did you ejaculate? 4 N/A
PX101001_Sexual_Stimulation_Intercourse_Orgasm_Climax PX101001110000 Over the past four weeks when you had sexual stimulation or intercourse, how often did you have the feeling of orgasm or climax? 4 N/A
PX101001_Sex_Relationship_Satisfied PX101001150000 Over the past four weeks how satisfied have you been with your sexual relationship with your partner? 4 N/A
Research Domain Information
Measure Name:

Male Sexual Function

Release Date:

April 11, 2017

Definition

Questions to determine whether a male participant has certain types of sexual function difficulties.

Purpose

The purpose of these questions is to determine whether the participant ever had sexual difficulties regarding erection and/or performance.

Keywords

Reproductive health, male sexual function, erectile dysfunction, International Index of Erectile Function, IIEF, Study for Future Families, SFF