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Citation
Landis, Richard (2014). Chronic Prostatitis Collaborative Research Network Clinical Trial - Alfuzosin (CPCRN2 RCT#1) (Version 2) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/801k-fj90
Data Availability Statement
Data from Chronic Prostatitis Collaborative Research Network Clinical Trial - Alfuzosin (CPCRN2 RCT#1) [(Version 2) https://doi.org/10.58020/801k-fj90] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The CPCRN2 RCT#1 study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the CPCRN2 RCT#1 (https://doi.org/10.58020/801k-fj90) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the CPCRN2 RCT#1 study and does not necessarily reflect the opinions or views of the CPCRN2 RCT#1 study, NIDDK-CR, or NIDDK.
Data Package Version
Version 2 (Updated on: Jun 13, 2014)
Resource Availability
  • Data Available for Request
  • Specimens Not Available
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General Description

The second phase of the Chronic Prostatitis Collaborative Research Network (CPCRN chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was established to conducted randomized clinical trials of promising therapies for this syndrome. In men with CP/CPPS , treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. In response to the findings of these previous trials, the CPCRN conducted a multicenter, randomized, placebo-controlled trial of alfuzosin to determine whether the symptoms CP/CPPS could be reduced in men who had recently received a diagnosis of CP/CPPS and who had not previously been treated with this class of drug.

Men with CP/CPPS were enrolled at 11 recruitment centers and randomly assigned in a 1:1 ratio to receive either 10 mg of alfuzosin or placebo once daily for 12 weeks. The trial was double-blind. There were four research-clinic visits during which data for the primary and secondary outcome measures were collected. The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least 4 points from baseline to 12 weeks, which is the minimal clinically significant difference in the score. Secondary outcome measures included evaluations of pain, urinary urgency, medical outcomes, mental health, and erectile dysfunction. Adverse events associated with treatment was assessed for each subject both overall and within each body system.

Results showed no difference between the placebo and the alfuzosin groups in the proportion of men with in an improvement of the NIH-CPSI score and a clinically meaningful reduction of symptoms. Similarly, there was no significant difference between the alfuzosin and placebo groups in multiple secondary outcomes, including the results of the global response assessment and measures of quality of life, depression, sexual function, and pain. These findings do not support the use of alfuzosin to reduce the symptoms of CP/CPPS in men who have not received prior treatment with an alpha-blocker.

Objectives

The primary aim of the study was to evaluate the efficacy and safety of the alpha-adrenergic blocker Alfuzosin (Uroxatral) in men who had recently received a diagnosis of CP/CPPS and who had not previously been treated with this class of drug.

Outcome Measure

The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least 4 points from baseline to 12 weeks, which is the minimal clinically significant difference in the score.

Secondary outcome measures included assessment of general pain and urinary urgency on a Likert scale and the McGill Pain Questionnaire; the Medical Outcomes Study Short Form Health Survey; the Hospital Anxiety and Depression Scale; the International Index of Erectile Function; and the Male Sexual Health Questionnaire. Toxicity was assessed for each subject both overall and within each body system.

Eligibility Criteria

Men of at least 18 years of age who exhibited: (1) symptoms bothersome enough to prompt a physician visit within the previous two years, (2) symptoms of pain or discomfort in the pelvic region for at least 6 weeks, and (3) a total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) were eligible for the study. Exclusion criteria are documented in the study protocol.

Outcome

The study found no difference between placebo and alfuzosin in the proportion of men with an improvement of at least four points in the NIH-CPSI score. Similarly, there was no significant difference between the alfuzosin and placebo groups in multiple secondary outcomes, including the results of the global response assessment and measures of quality of life, depression, sexual function, and pain. These findings do not support the use of alfuzosin to reduce the symptoms of CP/CPPS in men who have not received prior treatment with an alpha-blocker.

Research Area

Urologic Diseases

Study Type

Interventional

Study Sites

11

Study Start Date

2005-02

Study End Date

2008-01

Condition

Prostatitis

Keywords

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), NIH-CPSI, National Institutes of Health Chronic Prostatitis Symptom Index, Prostatic Disease, Urogenital Disease, Alfuzosin, Uroxatral, Pelvic Pain, Alpha-Adrenergic Blocker

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

39
Participants

Target Population
Adults

Sex

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Age

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Race

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Ethnicity

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Location

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Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
Download
CPCRN2 Alfuzosin Data Dictionary
Data Dictionary used as a collection of metadata - defines the variable contents of each datasetCodebook/Data DictionaryPDF
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov

Permitted Use(s) of the Resources
  • Use is allowed for any research purpose
Non-Public Documents (5)
Non-Public Documents Table
Document Name
Description
Document Type
File Format
Anal Primary Endpoint Analysis SAS Program
SAS Program used for completing the primary endpoint analysis for the cp01_long datasetFormats/Dataset InstructionSAS
CPCRN2 Alfuzosin SAS Formats
SAS formats for CPCRN2 Alfuzosin DataFormats/Dataset InstructionSAS
CPSI metan STATA Code
STATA code used for the calculation of 95% CI of rate difference adjusting for center-to-center variability for primary endpoint CPSI responder measureFormats/Dataset InstructionTXT
GRA metan STATA Code
STATA code used for calculation of 95% CI of rate difference adjusting for center-to-center variability for GRA responder measureFormats/Dataset InstructionTXT
Primary Manuscript SAS Program
SAS program used to reproduce the tables in the primary manuscript for the Alfuzosin trialFormats/Dataset InstructionSAS
Datasets (28)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
PRESCR Dataset
Captures data on the persons screened prior to consent230sas7bdat (80 KB); csv (20.84 KB)
CPSI resp metan Dataset
STATA calculation (using the metan procedure) of 95% CI for CPSI primary endpointdta (991 B)
GRA resp metan Dataset
STATA calculation (using the metan procedure) of 95% CI for GRA response measuredta (991 B)
EXAM Dataset
Captures data on the number of subjects with a completed physical exam form271sas7bdat (72 KB); csv (18.52 KB)
Analysis Dataset
Output data from procedure to calculate CI rate difference adjusting for center-to-center variability using cpsiresp_metan.sas7bdatlog (1.75 KB)
CP01 Long Dataset
Final longitudinal dataset with baseline, primary endpoint, secondary endpoints and other major information in main manuscripts272sas7bdat (328 KB); csv (120.86 KB)
ELIG Dataset
Captures data from checklist used to determine eligibility632sas7bdat (200 KB); csv (65.77 KB)
URINE Dataset
Captures data on the number of subjects who had a laboratory urine screening test271sas7bdat (40 KB); csv (16.43 KB)
GRA metan Dataset
Output data from STATA metan procedure for GRA response outcome measurelog (1.75 KB)