Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00103402
• Collaborator: University of Pennsylvania (Other)
• Enrollment: 272
• Locations: 10
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 27.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Condition or Disease	Intervention/Treatment	Phase
Prostatitis	Drug: Alfuzosin; Drug: Placebo	Phase 3

Detailed Description

The two primary objectives of this study are:

• To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).

• To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization.

There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected: visit 1 involves screening, visit 2 involves collection of baseline data and randomization, visit 3 is the 6-week evaluation, and visit 4 is the 12-week evaluation of the primary end point.

Study Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS) in Recently-Diagnosed and/or Newly-Symptomatic Alpha-blocker Naïve Patients
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alfuzosin 10 mg of alfuzosin once daily for 12 weeks	Drug: Alfuzosin
Placebo Comparator: Placebo 10 mg of an identical-looking placebo once daily for 12 weeks	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks [Baseline and 12 weeks]

   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

Secondary Outcome Measures

1. Global Response Assessment (GRA) [12 weeks]

   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).

2. Change in Subscales of the NIH-CPSI [Baseline and12 weeks]

   For 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.

3. Change in Subscales of the McGill Pain Questionnaire [Baseline and 12 weeks]

   For 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.

4. Change in Medical Outcomes Study Short Form 12 [Baseline and 12 weeks]

   For 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.

5. Change in Hospital Anxiety and Depression Scale [Baseline and 12 weeks]

   For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.

6. Change in International Index of Erectile Dysfunction (IIEF) [Baseline and 12 weeks]

   For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.

7. Change in Male Sexual Health Questionnaire [Baseline and 12 weeks]

   For 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant has signed and dated the appropriate Informed Consent document.

• Participant is male.

• Participant is at least 18 years of age.

• Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.

• Symptoms bothersome enough to prompt a physician visit have been present for two years or less.

Exclusion Criteria:

• Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).

• Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.

• Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.

• Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.

• Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.

• Participant has uninvestigated, significant hematuria.

• Participant has undergone transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.

• Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.

• Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	David Geffen School of Medicine at UCLA	Los Angeles	California	United States	90095
2	Stanford University Medical Center	Stanford	California	United States	94305
3	Northwestern U. Feinberg School of Medicine	Chicago	Illinois	United States	60611
4	University of Maryland	Baltimore	Maryland	United States	21201
5	Harvard Medical School- Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
7	Cleveland Clinic	Cleveland	Ohio	United States	44195
8	Temple University	Philadelphia	Pennsylvania	United States	19140
9	University of Washington- Harborview Medical Center	Seattle	Washington	United States	98108
10	Queen's University	Kingston	Ontario	Canada	K7L 3N6

Sponsors and Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• University of Pennsylvania

Investigators

• Study Director: Leroy Nyberg, MD PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Study Director: John Kusek, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Documents (Full-Text)

None provided.

More Information

Publications

• Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS; Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004 Oct 19;141(8):581-9.
• Litwin MS. A review of the development and validation of the National Institutes of Health Chronic Prostatitis Symptom Index. Urology. 2002 Dec;60(6 Suppl):14-8; discussion 18-9. Review.
• Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6.
• Schaeffer AJ, Datta NS, Fowler JE Jr, Krieger JN, Litwin MS, Nadler RB, Nickel JC, Pontari MA, Shoskes DA, Zeitlin SI, Hart C; Chronic Prostatitis Collaborative Research Network. Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Urology. 2002 Dec;60(6 Suppl):1-4. Review.
• Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O'Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM; Chronic Prostatitis Collaborative Research Network Group. Demographic and clinical characteristics of men with chronic prostatitis: the national institutes of health chronic prostatitis cohort study. J Urol. 2002 Aug;168(2):593-8.
• Schaeffer AJ; National Institute of Diabetes and Digestive and Kidney Diseases of the US National Institutes of Health. NIDDK-sponsored chronic prostatitis collaborative research network (CPCRN) 5-year data and treatment guidelines for bacterial prostatitis. Int J Antimicrob Agents. 2004 Sep;24 Suppl 1:S49-52.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT00103402
• Other Study ID Numbers: CPCRN2 Afluzosin; RFA-DK-03-004; U01DK065209
• First Posted: Feb 8, 2005
• Last Update Posted: Jun 12, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): Prostatitis; Non-bacterial Prostatitis; Prostatodynia; Alfuzosin; Alpha-adrenergic blocker
• Additional relevant MeSH terms: Prostatitis; Pelvic Pain; Alfuzosin

Study Results

Participant Flow

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Period Title: Overall Study
STARTED	138	134
COMPLETED	116	117
NOT COMPLETED	22	17

Baseline Characteristics

Arm/Group Title	Alfuzosin	Placebo	Total
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks	Total of all reporting groups
Overall Participants	138	134	272
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.1 (11.4)	40.1 (12.3)	40.1 (11.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	138 100%	134 100%	272 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	13 9.4%	14 10.4%	27 9.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	20 14.5%	16 11.9%	36 13.2%
White	88 63.8%	97 72.4%	185 68%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	17 12.3%	7 5.2%	24 8.8%
NIH-CPSI (units on a scale) [Mean (Standard Deviation) ]
Total score	23.8 (6.3)	25.1 (5.9)	24.5 (6.1)
Pain score	11.1 (3.3)	11.5 (3.4)	11.3 (3.4)
Urinary score	4.5 (2.8)	4.9 (2.9)	4.7 (2.9)
Quality of life score	4.5 (1.1)	4.7 (0.9)	4.6 (1.0)
Likert Pain and Urgency Scale (units on the scale) [Mean (Standard Deviation) ]
Average pain score	4.9 (2.0)	5.0 (1.9)	5.0 (2.0)
Urgency score	4.4 (2.6)	4.7 (2.6)	4.6 (2.6)
McGill Pain Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Total score	11.2 (8.6)	11.6 (8.7)	11.4 (8.7)
Sensory score	8.6 (5.9)	8.9 (6.2)	8.8 (6.1)
Affective score	2.6 (3.3)	2.6 (3.2)	2.6 (3.3)
SF-12 (units on a scale) [Mean (Standard Deviation) ]
Physical component summary	45.5 (9.6)	45.6 (8.4)	45.6 (9.0)
Mental component summary	44.0 (10.9)	44.9 (10.2)	44.5 (10.6)
Hospital Anxiety and Depression Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.8 (7.6)	12.8 (7.1)	12.8 (7.4)
International Index of Erectile Function (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	53.5 (17.9)	52.8 (17.4)	53.2 (17.7)
Male Sexual Health Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	30.0 (7.4)	30.4 (6.6)	30.2 (7.0)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks
Description	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
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	138	134
Count of Participants [Participants]	68 49.3%	66 49.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.
	Type of Statistical Test	Superiority
	Comments	The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Mantel Haenszel
	Comments	The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -11.2 to 11.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Global Response Assessment (GRA)
Description	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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	119	123
Marked improvement	23 16.7%	16 11.9%
Moderate improvement	25 18.1%	29 21.6%
Slight improvement	26 18.8%	32 23.9%
No change	36 26.1%	36 26.9%
Slight worsening	6 4.3%	5 3.7%
Moderate worsening	2 1.4%	4 3%
Marked worsening	1 0.7%	1 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)
	Type of Statistical Test	Superiority
	Comments	The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.
Statistical Test of Hypothesis	p-Value	0.90
	Comments
	Method	Mantel Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -9.0 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Subscales of the NIH-CPSI
Description	For 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.
Time Frame	Baseline and12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	116	117
Total score	-7.1 (9.0)	-6.5 (8.5)
Pain score	-3.3 (4.5)	-3.0 (4.4)
Urinary score	-1.2 (2.6)	-1.0 (2.6)
Quality-of-life score	-1.2 (1.5)	-1.2 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Total score (0-43) change from baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -2.7 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Pain score (0-21) change from baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -1.4 to 0.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Urinary score (0-10) change from baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.62
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.8 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Quality of life score (0-12) change from baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.99
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Subscales of the McGill Pain Questionnaire
Description	For 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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	112	116
Total score	-3.4 (6.4)	-3.1 (6.5)
Sensory score	-2.5 (5.0)	-2.3 (4.9)
Affective score	-1.0 (2.1)	-0.9 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	McGill Total Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -1.8 to 1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	McGill Sensory Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -1.4 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	McGill Affective Score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Medical Outcomes Study Short Form 12
Description	For 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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	115	113
Physical component	3.0 (7.4)	3.5 (8.1)
Mental component	4.0 (10.5)	1.9 (10.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Physical component summary (0-100) change in scores
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -2.3 to 1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments	Mental component summary (0-100) Absolute Difference between Groups (95% CI)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 4.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change in Hospital Anxiety and Depression Scale
Description	For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	115	117
Mean (Standard Deviation) [units on a scale]	-2.6 (5.7)	-1.5 (5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -2.4 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change in International Index of Erectile Dysfunction (IIEF)
Description	For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	110	109
Mean (Standard Deviation) [units on a scale]	0.5 (12.7)	-0.2 (14.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -2.6 to 4.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Male Sexual Health Questionnaire
Description	For 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.
Time Frame	Baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alfuzosin	Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks	10 mg of an identical-looking placebo once daily for 12 weeks
Measure Participants	107	111
Mean (Standard Deviation) [units on a scale]	1.7 (4.5)	0.6 (6.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alfuzosin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -0.3 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Alfuzosin		Placebo
Arm/Group Description	10 mg of alfuzosin once daily for 12 weeks		10 mg of an identical-looking placebo once daily for 12 weeks
All Cause Mortality
	Alfuzosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/134 (0%)
Serious Adverse Events
	Alfuzosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/138 (0.7%)		2/134 (1.5%)
Cardiac disorders
Myocardial infarction	0/138 (0%)	0	1/134 (0.7%)	1
Investigations
Traumatic head laceration	0/138 (0%)	0	1/134 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Spontaneous pneumothorax	1/138 (0.7%)	1	0/134 (0%)	0
Other (Not Including Serious) Adverse Events
	Alfuzosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/138 (29%)		46/134 (34.3%)
Gastrointestinal disorders
Gastrointestinal events	10/138 (7.2%)	10	13/134 (9.7%)	13
General disorders
Constitutional events	4/138 (2.9%)	4	7/134 (5.2%)	7
Pain in any body system	15/138 (10.9%)	15	20/134 (14.9%)	20
Nervous system disorders
Neurologic events	11/138 (8%)	11	6/134 (4.5%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.