Trial Outcomes & Findings for Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (NCT NCT00103402)
NCT ID: NCT00103402
Last Updated: 2020-06-12
Results Overview
For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-06-12
Participant Flow
Participant milestones
| Measure |
Alfuzosin
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
134
|
|
Overall Study
COMPLETED
|
116
|
117
|
|
Overall Study
NOT COMPLETED
|
22
|
17
|
Reasons for withdrawal
| Measure |
Alfuzosin
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
|
Overall Study
Dissatisfied/No longer interested
|
6
|
6
|
|
Overall Study
Personal constraints/Other
|
5
|
0
|
Baseline Characteristics
Based on completed questionnaires
Baseline characteristics by cohort
| Measure |
Alfuzosin
n=138 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=134 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 11.4 • n=138 Participants
|
40.1 years
STANDARD_DEVIATION 12.3 • n=134 Participants
|
40.1 years
STANDARD_DEVIATION 11.8 • n=272 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=138 Participants
|
134 Participants
n=134 Participants
|
272 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=138 Participants
|
14 Participants
n=134 Participants
|
27 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=138 Participants
|
16 Participants
n=134 Participants
|
36 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=138 Participants
|
97 Participants
n=134 Participants
|
185 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=138 Participants
|
7 Participants
n=134 Participants
|
24 Participants
n=272 Participants
|
|
NIH-CPSI
Total score
|
23.8 units on a scale
STANDARD_DEVIATION 6.3 • n=138 Participants
|
25.1 units on a scale
STANDARD_DEVIATION 5.9 • n=134 Participants
|
24.5 units on a scale
STANDARD_DEVIATION 6.1 • n=272 Participants
|
|
NIH-CPSI
Pain score
|
11.1 units on a scale
STANDARD_DEVIATION 3.3 • n=138 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 3.4 • n=134 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 3.4 • n=272 Participants
|
|
NIH-CPSI
Urinary score
|
4.5 units on a scale
STANDARD_DEVIATION 2.8 • n=138 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.9 • n=134 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 2.9 • n=272 Participants
|
|
NIH-CPSI
Quality of life score
|
4.5 units on a scale
STANDARD_DEVIATION 1.1 • n=138 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.9 • n=134 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 1.0 • n=272 Participants
|
|
Likert Pain and Urgency Scale
Average pain score
|
4.9 units on the scale
STANDARD_DEVIATION 2.0 • n=138 Participants
|
5.0 units on the scale
STANDARD_DEVIATION 1.9 • n=134 Participants
|
5.0 units on the scale
STANDARD_DEVIATION 2.0 • n=272 Participants
|
|
Likert Pain and Urgency Scale
Urgency score
|
4.4 units on the scale
STANDARD_DEVIATION 2.6 • n=138 Participants
|
4.7 units on the scale
STANDARD_DEVIATION 2.6 • n=134 Participants
|
4.6 units on the scale
STANDARD_DEVIATION 2.6 • n=272 Participants
|
|
McGill Pain Questionnaire
Total score
|
11.2 units on a scale
STANDARD_DEVIATION 8.6 • n=134 Participants • Based on completed questionnaires
|
11.6 units on a scale
STANDARD_DEVIATION 8.7 • n=133 Participants • Based on completed questionnaires
|
11.4 units on a scale
STANDARD_DEVIATION 8.7 • n=267 Participants • Based on completed questionnaires
|
|
McGill Pain Questionnaire
Sensory score
|
8.6 units on a scale
STANDARD_DEVIATION 5.9 • n=134 Participants • Based on completed questionnaires
|
8.9 units on a scale
STANDARD_DEVIATION 6.2 • n=133 Participants • Based on completed questionnaires
|
8.8 units on a scale
STANDARD_DEVIATION 6.1 • n=267 Participants • Based on completed questionnaires
|
|
McGill Pain Questionnaire
Affective score
|
2.6 units on a scale
STANDARD_DEVIATION 3.3 • n=134 Participants • Based on completed questionnaires
|
2.6 units on a scale
STANDARD_DEVIATION 3.2 • n=133 Participants • Based on completed questionnaires
|
2.6 units on a scale
STANDARD_DEVIATION 3.3 • n=267 Participants • Based on completed questionnaires
|
|
SF-12
Physical component summary
|
45.5 units on a scale
STANDARD_DEVIATION 9.6 • n=136 Participants • Based on completed questionnaires
|
45.6 units on a scale
STANDARD_DEVIATION 8.4 • n=130 Participants • Based on completed questionnaires
|
45.6 units on a scale
STANDARD_DEVIATION 9.0 • n=266 Participants • Based on completed questionnaires
|
|
SF-12
Mental component summary
|
44.0 units on a scale
STANDARD_DEVIATION 10.9 • n=136 Participants • Based on completed questionnaires
|
44.9 units on a scale
STANDARD_DEVIATION 10.2 • n=130 Participants • Based on completed questionnaires
|
44.5 units on a scale
STANDARD_DEVIATION 10.6 • n=266 Participants • Based on completed questionnaires
|
|
Hospital Anxiety and Depression Scale
|
12.8 units on a scale
STANDARD_DEVIATION 7.6 • n=137 Participants • Based on completed questionnaires
|
12.8 units on a scale
STANDARD_DEVIATION 7.1 • n=133 Participants • Based on completed questionnaires
|
12.8 units on a scale
STANDARD_DEVIATION 7.4 • n=270 Participants • Based on completed questionnaires
|
|
International Index of Erectile Function
|
53.5 units on a scale
STANDARD_DEVIATION 17.9 • n=133 Participants • Based on completed questionnaires
|
52.8 units on a scale
STANDARD_DEVIATION 17.4 • n=126 Participants • Based on completed questionnaires
|
53.2 units on a scale
STANDARD_DEVIATION 17.7 • n=259 Participants • Based on completed questionnaires
|
|
Male Sexual Health Questionnaire
|
30.0 units on a scale
STANDARD_DEVIATION 7.4 • n=130 Participants • Based on completed questionnaires
|
30.4 units on a scale
STANDARD_DEVIATION 6.6 • n=126 Participants • Based on completed questionnaires
|
30.2 units on a scale
STANDARD_DEVIATION 7.0 • n=256 Participants • Based on completed questionnaires
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksFor the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks
Outcome measures
| Measure |
Alfuzosin
n=138 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=134 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks
|
68 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The analysis population for this outcome is larger than the number of participants who completed the trial because a few participant answered this question without completing the other questionnaires
The response rate for the global response assessment was based on marked or moderate improvement at 12 weeks using a 7 point scale (marked worsening, moderate worsening, no change, slight improvement, moderate improvement, marked improvement).
Outcome measures
| Measure |
Alfuzosin
n=119 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=123 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Global Response Assessment (GRA)
Moderate worsening
|
2 Participants
|
4 Participants
|
|
Global Response Assessment (GRA)
Marked improvement
|
23 Participants
|
16 Participants
|
|
Global Response Assessment (GRA)
Slight improvement
|
26 Participants
|
32 Participants
|
|
Global Response Assessment (GRA)
No change
|
36 Participants
|
36 Participants
|
|
Global Response Assessment (GRA)
Moderate improvement
|
25 Participants
|
29 Participants
|
|
Global Response Assessment (GRA)
Slight worsening
|
6 Participants
|
5 Participants
|
|
Global Response Assessment (GRA)
Marked worsening
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and12 weeksFor the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI), higher scores indicate more severe symptoms (for the quality-of-life score, higher scores indicate a more negative effect). Score ranges are as follows: total score, 0 to 43; pain score, 0 to 21; urinary score, 0 to 10, quality-of-life score, 0 to 12; and average pain and urgency scores, 0 to 10.
Outcome measures
| Measure |
Alfuzosin
n=116 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=117 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Change in Subscales of the NIH-CPSI
Total score
|
-7.1 units on a scale
Standard Deviation 9.0
|
-6.5 units on a scale
Standard Deviation 8.5
|
|
Change in Subscales of the NIH-CPSI
Pain score
|
-3.3 units on a scale
Standard Deviation 4.5
|
-3.0 units on a scale
Standard Deviation 4.4
|
|
Change in Subscales of the NIH-CPSI
Urinary score
|
-1.2 units on a scale
Standard Deviation 2.6
|
-1.0 units on a scale
Standard Deviation 2.6
|
|
Change in Subscales of the NIH-CPSI
Quality-of-life score
|
-1.2 units on a scale
Standard Deviation 1.5
|
-1.2 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksFor the McGill Pain Questionnaire, higher scores indicate greater pain. Score ranges are as follows: total score, 0 to 45; sensory score, 0 to 33; affective score, 0 to 12.
Outcome measures
| Measure |
Alfuzosin
n=112 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=116 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Change in Subscales of the McGill Pain Questionnaire
Total score
|
-3.4 units on a scale
Standard Deviation 6.4
|
-3.1 units on a scale
Standard Deviation 6.5
|
|
Change in Subscales of the McGill Pain Questionnaire
Sensory score
|
-2.5 units on a scale
Standard Deviation 5.0
|
-2.3 units on a scale
Standard Deviation 4.9
|
|
Change in Subscales of the McGill Pain Questionnaire
Affective score
|
-1.0 units on a scale
Standard Deviation 2.1
|
-0.9 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksFor the Medical Outcomes Study Short Form Health Survey 12 (SF-12), higher scores indicate better quality of life. Score range for both the physical and mental component summaries is 0 to 100.
Outcome measures
| Measure |
Alfuzosin
n=115 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=113 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Change in Medical Outcomes Study Short Form 12
Physical component
|
3.0 units on a scale
Standard Deviation 7.4
|
3.5 units on a scale
Standard Deviation 8.1
|
|
Change in Medical Outcomes Study Short Form 12
Mental component
|
4.0 units on a scale
Standard Deviation 10.5
|
1.9 units on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksFor the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.
Outcome measures
| Measure |
Alfuzosin
n=115 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=117 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale
|
-2.6 units on a scale
Standard Deviation 5.7
|
-1.5 units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksFor the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.
Outcome measures
| Measure |
Alfuzosin
n=110 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=109 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Change in International Index of Erectile Dysfunction (IIEF)
|
0.5 units on a scale
Standard Deviation 12.7
|
-0.2 units on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksFor the Male Sexual Health Questionnaire, higher scores indicate better function with respect to erection and ejaculation and greater satisfaction with sexual life; range, 0 to 40.
Outcome measures
| Measure |
Alfuzosin
n=107 Participants
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=111 Participants
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Change in Male Sexual Health Questionnaire
|
1.7 units on a scale
Standard Deviation 4.5
|
0.6 units on a scale
Standard Deviation 6.8
|
Adverse Events
Alfuzosin
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alfuzosin
n=138 participants at risk
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=134 participants at risk
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Spontaneous pneumothorax
|
0.72%
1/138 • Number of events 1 • 12 weeks
|
0.00%
0/134 • 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/138 • 12 weeks
|
0.75%
1/134 • Number of events 1 • 12 weeks
|
|
Investigations
Traumatic head laceration
|
0.00%
0/138 • 12 weeks
|
0.75%
1/134 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Alfuzosin
n=138 participants at risk
10 mg of alfuzosin once daily for 12 weeks
|
Placebo
n=134 participants at risk
10 mg of an identical-looking placebo once daily for 12 weeks
|
|---|---|---|
|
General disorders
Constitutional events
|
2.9%
4/138 • Number of events 4 • 12 weeks
|
5.2%
7/134 • Number of events 7 • 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal events
|
7.2%
10/138 • Number of events 10 • 12 weeks
|
9.7%
13/134 • Number of events 13 • 12 weeks
|
|
Nervous system disorders
Neurologic events
|
8.0%
11/138 • Number of events 11 • 12 weeks
|
4.5%
6/134 • Number of events 6 • 12 weeks
|
|
General disorders
Pain in any body system
|
10.9%
15/138 • Number of events 15 • 12 weeks
|
14.9%
20/134 • Number of events 20 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place