IPCA-CPDQ – LIFEGENE

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IPCA-CPDQ – LIFEGENE

Clinical Practice Documentation Questionnaire for Rapilif-M Combikit

Initials:

D.O.B:

Weight (in Kg):

Height (in m):

Pulse Rate:

BP:

Obesity *

Diabetes *

Cardiovascular Disease (CVD): *

Hypercholestrolemia *

Hypertension (HTN): *

Kidney Impairment *

Liver Impairment *

Other systemic condition(s) if any, please specify

Any Surgery:

Any Cancer:

Other urinary symptom(s) if any, please specify:

2. What was the Rapilif-M combikit (henceforth referred to as 'the combikit') given as?

A. First-line therapy
C. Switch-over from other drug combinations (a-blocker plus anticholinergic)
B. Replacement to silodosin monotherapy

3. What was the reason if the combikit was prescribed as a replacement to silodosin (or any other a-blocker) monotherapy?

A. Symptoms were not relieved
C. Other reason, specify
B. An adverse event occurred

4. If prescribed as a switch-over from other drug combination (a-blocker plus anticholinergic), please select the previously administered drug combination.

5. What was the reason if the combikit was prescribed as a switch-over from other drug combination?

A. Symptoms were not relieved
C. Other reason, specify:
B. An adverse event occurred

6. How long was the combikit prescribed?

A. 0-4 weeks
C. 8-12 weeks
B. 4-8 weeks
D. > 12weeks

7. What was the daily dose prescribed?

A. Silodosin 8 mg + mirabegron 25 mg
B. Silodosin 8 mg + mirabegron 50 mg

8.What was the effect of treatment with the combikit on the patient's BPH symptoms?

A. Remarkable improvement
C. Minimal improvement
B. Moderate improvement
D. No improvement

9. What were the pre-treatment and post-treatment total IPSS scores?

A. Pre-treatment:
B. Post-treatment:

INTERNATIONAL PROSTATE SYMPTOM SCORE SHEET

	Not at all (0)	Less than 1 times in 5 (1)	Less than half the time (2)	About half the time (3)	More than half the time (4)	Almost Always (5)	Your score
1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating?	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? Not at all (0)	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? Less than 1 times in 5 (1)	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? Less than half the time (2)	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? About half the time (3)	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? More than half the time (4)	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? Almost Always (5)	1. Incomplete Emptying Over the past month, how often have you had asensation of not emptying your bladdercompletely after you finished urinating? Your score
2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating?	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? Not at all (0)	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? Less than 1 times in 5 (1)	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? Less than half the time (2)	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? About half the time (3)	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? More than half the time (4)	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? Almost Always (5)	2. Frequency Over the past month, how often have youhad to urinate again less than two hours after you finished urinating? Your score
3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated?	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? Not at all (0)	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? Less than 1 times in 5 (1)	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? Less than half the time (2)	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? About half the time (3)	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? More than half the time (4)	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? Almost Always (5)	3. Intermittency Over the past month, how often have youfound you stopped and started several timeswhen you urinated? Your score
4. Urgency Over the past month, how often have youfound it diffcult to postpone urination?	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? Not at all (0)	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? Less than 1 times in 5 (1)	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? Less than half the time (2)	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? About half the time (3)	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? More than half the time (4)	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? Almost Always (5)	4. Urgency Over the past month, how often have youfound it diffcult to postpone urination? Your score
5. Weak Stream Over the past month, how often have youhad a weak urinary stream?	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? Not at all (0)	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? Less than 1 times in 5 (1)	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? Less than half the time (2)	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? About half the time (3)	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? More than half the time (4)	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? Almost Always (5)	5. Weak Stream Over the past month, how often have youhad a weak urinary stream? Your score
6. Straining Over the past month, how often have youhad to push or strain to begin urination?	6. Straining Over the past month, how often have youhad to push or strain to begin urination? Not at all (0)	6. Straining Over the past month, how often have youhad to push or strain to begin urination? Less than 1 times in 5 (1)	6. Straining Over the past month, how often have youhad to push or strain to begin urination? Less than half the time (2)	6. Straining Over the past month, how often have youhad to push or strain to begin urination? About half the time (3)	6. Straining Over the past month, how often have youhad to push or strain to begin urination? More than half the time (4)	6. Straining Over the past month, how often have youhad to push or strain to begin urination? Almost Always (5)	6. Straining Over the past month, how often have youhad to push or strain to begin urination? Your score
7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times Not at all (0)	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times Less than 1 times in 5 (1)	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times Less than half the time (2)	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times About half the time (3)	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times More than half the time (4)	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times Almost Always (5)	7. Nocturia Over the past month, how many times didyou mast typically get up to urinate from thetime you went to bed of night until the time you gat up in the morning? None-1, Time-2, Time-3, Time-4, 5 or more Times Your score

Which of the above do you regard as most troublesome (1-7)

Total Prostate Symptom Score

10. What was the effect of treatment with the combikit on the patient's OAB symptoms?

A. Remarkable improvement
C. Minimal improvement
B. Moderate improvement
D. No improvement

11. What were the pre-treatment and post-treatment total OABSS scores?

A. Pre-treatment:
B. Post-treatment:

OVERACTlVE BLADDER SYMPTOM SCORE (OABSS) QUESTIONNAIRE

	Delighted (0)	Pleased (1)	Mostly satisfied (2)	Mixed satisfied and dissatisfied (3)	Mostly dissatisfied (4)	Unhappy (5)	Terrible
1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one).	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Delighted (0)	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Pleased (1)	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Mostly satisfied (2)	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Mixed satisfied and dissatisfied (3)	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Mostly dissatisfied (4)	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Unhappy (5)	1. Quality of life due to urinary symptomsIf you were to spend the rest of your life withyour urinary condition just the way it is now,how would you feel about that? (tick one). Terrible

How many times do you typically urinate from waking in the morning until sleeping at night?

≤ 7 (0)
8-14 (1)
≥ 14 (2)

Frequency (Score)

How many times do you typically wake up to urinate from sleeping at night until waking in the morning?

0 (0)
1 (1)
2 (2)
≥ 3 (3)

Frequency (Score)

How often do you have a sudden desire to urinate, which is difficult to defer?

Frequency (Score)

How often do you leak urine because you cannot defer the sudden desire to urinate?

Frequency (Score)

12. How was the patient's compliance with the combikit treatment?

A. Excellent
C. Average
B. Good
D. Poor

13.Were any cf the following side-effects observed secondary to treatment with the combikit?