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Protocol - Male Sexual Function

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Protocol Name from Source:

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

Availability:

Publicly available

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

Personnel and Training Required

None

Equipment Needs

Pencil and paper

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adult

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.

Research Domain Information

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.

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 Function3007476CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Male sexual func proto62666-3LOINC

Process and Review

The [link[www.phenx.org/node/110|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[www.phenxtoolkit.org/index.php?pageLink=resources.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_Difficulty_Achieving_ErectionPX101001010100How often did you have difficulty with Achieving an erection?4N/A
PX101001_Difficulty_Ejaculating_EarlyPX101001010200How often did you have difficulty with Ejaculating too early?4N/A
PX101001_Difficulty_EjaculatingPX101001010300How often did you have difficulty with Difficulty ejaculating?4N/A
PX101001_Difficulty_Lack_Interest_SexPX101001010400How often did you have difficulty with Lack of interest in sex?4N/A
PX101001_Erection_During_Sexual_ActivityPX101001020000Over the past four weeks how often were you able to get an erection during sexual activity?4N/A
PX101001_Erection_Hard_Enough_PenetrationPX101001030000Over the past four weeks when you had erections with sexual stimulation, how often were your erections hard enough for penetration?4N/A
PX101001_Penetrate_Sexual_IntercoursePX101001040000Over the past four weeks when you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?4N/A
PX101001_Maintain_Erection_After_PenetratedPX101001050000Over the past four weeks during sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?4N/A
PX101001_Maintain_Erection_Completion_IntercoursePX101001060000Over the past four weeks during sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?4N/A
PX101001_Attempt_Sexual_Intercourse_TimesPX101001070000Over the past four weeks how many times have you attempted sexual intercourse?4N/A
PX101001_Attempt_Sexual_Intercourse_SatisfactoryPX101001080000Over the past four weeks when you attempted sexual intercourse, how often was it satisfactory for you?4N/A
PX101001_Enjoy_Sexual_IntercoursePX101001090000Over the past four weeks how much have you enjoyed sexual intercourse?4N/A
PX101001_Sexual_Stimulation_Intercourse_EjaculatePX101001100000Over the past four weeks when you had sexual stimulation or intercourse, how often did you ejaculate?4N/A
PX101001_Sexual_Stimulation_Intercourse_Orgasm_ClimaxPX101001110000Over the past four weeks when you had sexual stimulation or intercourse, how often did you have the feeling of orgasm or climax?4N/A
PX101001_Sexual_Desire_FeltPX101001120000Over the past four weeks how often have you felt sexual desire?4N/A
PX101001_Sexual_Desire_Level_RatePX101001130000Over the past four weeks how would you rate your level of sexual desire?4N/A
PX101001_Overall_Sex_Life_SatisfiedPX101001140000Over the past four weeks how satisfied have you been with your overall sex life?4N/A
PX101001_Sex_Relationship_SatisfiedPX101001150000Over the past four weeks how satisfied have you been with your sexual relationship with your partner?4N/A
PX101001_Confidence_Get_Keep_ErectionPX101001160000Over the past four weeks how do you rate your confidence that you could get and keep an erection?4N/A