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Protocol - Prostate Symptoms

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Description:

The interviewer asks the male participant to complete the questionnaire, which includes questions about how often he urinates at night, whether he has incomplete bladder emptying, urinary frequency, urinary urgency, difficulty urinating and also about the quality of life associated with urination. Note that the questions in this protocol, the International Prostate Symptom Score (I-PSS), were previously called the American Urological Association Symptom Index.

Protocol:

International Prostate Symptom Score (I-PSS)

Patient Name: _________________ Date of birth: ______ Date completed: ______

In the past month:

Not at All

Less than 1 in 5 Times

Less than Half the Time

About Half the Time

More than Half the Time

Almost Always

Your Score

1. Incomplete Emptying

How often have you had the sensation of not emptying your bladder?

0

1

2

3

4

5

2. Frequency

How often have you had to urinate less than every two hours?

0

1

2

3

4

5

3. Intermittency

How often have you found you stopped and started again several times when you urinated?

0

1

2

3

4

5

4. Urgency

How often have you found it difficult to postpone urination?

0

1

2

3

4

5

5. Weak Stream

How often have you had a weak urinary stream?

0

1

2

3

4

5

6. Straining

How often have you had to strain to start urination?

0

1

2

3

4

5

None

1 Time

2 Times

3 Times

4 Times

5 Times

7. Nocturia

How many times did you typically get up at night to urinate?

0

1

2

3

4

5

Total I-PSS Score

Score: 1-7: Mild 8-19: Moderate 20-35: Severe

Quality of Life Due to Urinary Symptoms:

Delighted

Pleased

Moder-ately Satisfied

Mixed

Mostly Dissatis-fied

Unhappy

Terrible

If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?

0

1

2

3

4

5

6

About the I-PSS

The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

The questions refer to the following urinary symptoms:

Questions Symptom

1 Incomplete emptying

2 Frequency

3 Intermittency

4 Urgency

5 Weak Stream

6 Straining

7 Nocturia

Question eight refers to the patient’s perceived quality of life.

The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows:

Mild (symptom score less than or equal to 7)

Moderate (symptom score range 8-19)

Severe (symptom score range 20-35)

The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from “delighted” to “terrible” or 0 to 6. Although this single question may or may not capture the global impact of benign prostatic hyperplasia (BPH) Symptoms or quality of life, it may serve as a valuable starting point for a doctor-patient conversation.

The SCI has agreed to use the symptom index for BPH, which has been developed by the AUA Measurement Committee, as the official worldwide symptoms assessment tool for patients suffering from prostatism.

The SCI recommends that physicians consider the following components for a basic diagnostic workup: history; physical exam; appropriate labs, such as U/A, creatine, etc.; and DRE or other evaluation to rule out prostate cancer.

Translations of the I-PSS are available at the Mapi Research Trust website for a fee. Go to http://www.mapi-trust.org/resources/questionnaires/ for more details.

Protocol Name from Source:

International Prostate Symptom Score (I-PSS)

Availability:

Publicly available

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.

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

Interviewer-administered questionnaire

Life Stage:

Adult

Participants:

Adult males

Specific Instructions:

The PhenX Reproductive Health Working Group recommends asking male participants ages 40 and older.

Selection Rationale

Specific genito-urinary symptoms are related to benign prostatic hyperplasia. The International Prostate Symptom Score (I-PSS) is the current international standard.

Language

English, Other languages available via Mapi Trust

Standards
StandardNameIDSource
Common Data Elements (CDE) Male Prostatic Symptom Assessment Description Text 3007486 CDE Browser
Process and Review

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

Guidance from ERP 5 includes the following:

· Changed the name of the measure

· Replaced protocol

· New Data Dictionary

Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive (link)

Source

Barry, M. J., Fowler, F. J., O’Leary, M. P., Bruskewitz, R. C., Holtgrewe, H. L., Mebust, W. K., & Cockett, A. T. (1992). The American Urological Association Symptom Index for benign prostatic hyperplasia. Journal of Urology, 148(5), 1549-1557.

General References

Cockett, A. T., Aso, Y., Denis, L., Murphy, G., Khoury, S., et al. (1993). Recommendations of the International Consensus Committee (pp. 553-564). In A. T. Cockett, S. Khoury, Y. Aso, C. Chatelain, L. Denis, K. Griffiths, & G. Murphy (Eds.), The Second International Consultation of Benign Prostatic Hyperplasia (BPH). Paris.

Sciarra, A., D’Eramo, G., Casale, P., Loreto, A., Buscarini, M., Di Nicola, S., Seccareccia, F., & Di Silverio, F. (1998). Relationship among symptom score, prostate volume, and urinary flow rates in 543 patients with and without benign prostatic hyperplasia. Prostate, 34(2), 121-128.

Protocol ID:

101202

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
Research Domain Information
Measure Name:

Prostate Symptoms

Release Date:

April 11, 2017

Definition

Questions to assess males’ prostate symptoms.

Purpose

This measure assesses participants’ urinary symptoms due to benign prostatic hyperplasia (BPH), a common medical condition in men over the age of 50 years.

Keywords

Reproductive health, prostate, International Prostate Symptom Score, I-PSS