Protocol - Prostate Symptoms

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.

Specific Instructions

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

Availability

Available

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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.

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 Category	Required
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

Lifestage

Adult

Participants

Adult males

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 at source

Standards

Standard	Name	ID	Source
Human Phenotype Ontology	Abnormality of the prostate	HP:0008775	HPO
caDSR Form	PhenX PX101202 - Prostate Symptoms	6872521	caDSR Form

Derived Variables

None

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)

Protocol Name from Source

International Prostate Symptom Score (I-PSS)

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 Name	Variable ID	Variable Description	dbGaP Mapping
PX101202_Prostate_Symptoms_Incomplete_Emptying_Past_Month
	PX101202010100	In the past month: (Incomplete emptying) How more often have you had the sensation of not emptying your bladder? show less	N/A
PX101202_Prostate_Symptoms_Quality_Life_Assessment_Scale
	PX101202020000	If you were to spend the rest of your life more with your urinary condition just the way it is now, how would you feel about that? show less	N/A
PX101202_Prostate_Symptoms_Urination_Frequency_Past_Month
	PX101202010200	In the past month: (Frequency) How often more have you had to urinate less than every two hours? show less	N/A
PX101202_Prostate_Symptoms_Urination_Intermittency_Past_Month
	PX101202010300	In the past month: (Intermittency) How often more have you found you stopped and started again several times when you urinated? show less	N/A
PX101202_Prostate_Symptoms_Urination_Nocturia_Past_Month
	PX101202010700	In the past month: (Nocturia) How many times more did you typically get up at night to urinate? show less	N/A
PX101202_Prostate_Symptoms_Urination_Straining_Past_Month
	PX101202010600	In the past month: (Straining) How often more have you had to strain to start urination? show less	N/A
PX101202_Prostate_Symptoms_Urination_Urgency_Past_Month
	PX101202010400	In the past month: (Urgency) How often have more you found it difficult to postpone urination? show less	N/A
PX101202_Prostate_Symptoms_Urination_Weak_Stream_Past_Month
	PX101202010500	In the past month: (Weak stream) How often more have you had a weak urinary stream? show less	N/A

Reproductive Health

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

Measure Protocols

Protocol ID	Protocol Name
101202	Prostate Symptoms

Publications

There are no publications listed for this protocol.