Evidence map›Paper›PMID 20876412›Full record

Trial reportArchives of internal medicine2010

Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial.

Michel A Pontari, John N Krieger, Mark S Litwin, Paige C White, Rodney U Anderson, Mary McNaughton-Collins, J Curtis Nickel, Daniel A Shoskes, Richard B Alexander, Michael O'Leary and 9 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of internal medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00371033 (A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
8.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00371033 phase3completednot on this map

A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2006 to 2008Enrolled324ConditionsChronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)ArmsPregabalin, Placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pregabalin for chronic prostatitis.The Cochrane database of systematic reviews · 2012
    Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Male CP/CPPS: where do we stand?World journal of urology · 2019
    Review
  16. Review
  17. Chronic prostatitis: current treatment options.Research and reports in urology · 2019
    Review
  18. Management of Chronic Prostatitis (CP).Current urology reports · 2018
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 11 institutions in 2 countries.

Michel A PontariDepartment of Urology, Temple University School of Medicine, Philadelphia, Pennsylvania 19140, USA. Pontarm@tuhs.temple.edu
John N Krieger
Mark S Litwin
Paige C White
Rodney U Anderson
Mary McNaughton-Collins
J Curtis Nickel
Daniel A Shoskes
Richard B Alexander
Michael O'Leary
Scott Zeitlin
Shannon Chuai
J Richard Landis
Liyi Cen
Kathleen J Propert
John W Kusek
Leroy M Nyberg
Anthony J Schaeffer
Chronic Prostatitis Collaborative Research Network-2
University of Pennsylvania · USHarvard University · USUniversity of California, Los Angeles · USCleveland Clinic · USNational Institute of Diabetes and Digestive and Kidney Diseases · USQueen's University · CAStanford University · USTemple University Health System · USUniversity of Maryland, College Park · USUniversity of Mississippi · USUniversity of Washington · US

Funding

Data Coordinating Center for CPCRN and ICCRNU01DK065209 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI LANDIS, J RICHARD · 2003 to 2007
$7.1M
Chronic Prostatitis Collaborative Research NetworkU01DK065277 · NIDDK · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SCHAEFFER, ANTHONY J · 2003 to 2007
$2.0M
Chronic Prostatitis Collaborative Research Network CPCRNU01DK065174 · NIDDK · QUEEN'S UNIVERSITY AT KINGSTON · PI NICKEL, JOHN CURTIS · 2003 to 2007
$1.9M
Chronic prostatitis collaborative clinical studiesU01DK065268 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI ALEXANDER, RICHARD B · 2003 to 2007
$1.7M
Chronic Prostatitis Collaborative Research NetworkU01DK065297 · NIDDK · STANFORD UNIVERSITY · PI ANDERSON, RODNEY U · 2003 to 2007
$1.6M
Chronic Prostatitis Collaborative Clinical TrialsU01DK065187 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI MCNAUGHTON-COLLINS, MARY F · 2003 to 2007
$1.6M
Chronic Prostatitis Collaborative Research NetworkU01DK065257 · NIDDK · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LITWIN, MARK S. · 2003 to 2007
$1.6M
Clinical Trial Development in Chronic Pelvic Pain Syndr*U01DK065189 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI SHOSKES, DANIEL · 2003 to 2007
$1.3M
UW/USM Chronic Prostatitis CRCU01DK065266 · NIDDK · UNIVERSITY OF WASHINGTON · PI KRIEGER, JOHN N · 2003 to 2007
$1.2M
Chronic Prostatitis Collaborative Research NetworkU01DK065186 · NIDDK · TEMPLE UNIV OF THE COMMONWEALTH · PI PONTARI, MICHEL · 2003 to 2007
$1.2M
Becoming a member of the CPCRN-for prostatitisU01DK065287 · NIDDK · UNIVERSITY OF WASHINGTON · PI BERGER, RICHARD A · 2003 to 2005
$819k
NIDDK NIH HHS U01 DK065174NIDDK NIH HHS U01 DK065186NIDDK NIH HHS U01 DK065187NIDDK NIH HHS U01 DK065189NIDDK NIH HHS U01 DK065209NIDDK NIH HHS U01 DK065257NIDDK NIH HHS U01 DK065266NIDDK NIH HHS U01 DK065268NIDDK NIH HHS U01 DK065277NIDDK NIH HHS U01 DK065287NIDDK NIH HHS U01 DK065297NIDDK NIH HHS U01 DK65174NIDDK NIH HHS U01 DK65186NIDDK NIH HHS U01 DK65187NIDDK NIH HHS U01 DK65189NIDDK NIH HHS U01 DK65209NIDDK NIH HHS U01 DK65257NIDDK NIH HHS U01 DK65266NIDDK NIH HHS U01 DK65277NIDDK NIH HHS U01 DK65287NIDDK NIH HHS U01 DK65297NIDDK NIH HHS UO1DK65268
6 · The paper itself

Abstract

backgroundEvidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic.

methodsThis randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS symptoms. In 2006-2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed.

resultsOf 218 men assigned to receive pregabalin, 103 (47.2%) reported at least a 6-point decrease in the NIH-CPSI total score at 6 weeks compared with 35.8% (38 of 106 men) assigned to receive placebo (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites). Compared with the placebo group, men assigned to receive pregabalin experienced reductions in the NIH-CPSI total score and subscores (P < .05), a higher Global Response Assessment response rate (31.2% and 18.9%; P = .02), and improvement in total McGill Pain Questionnaire score (P = .01). Results for the other outcomes did not differ between groups.

conclusionPregabalin therapy for 6 weeks was not superior to placebo use in the rate of a 6-point decrease (improvement) in the NIH-CPSI total score in men with CP/CPPS.

trial registrationclinicaltrials.gov Identifier: NCT00371033.

Indexed as

AdultAgedAnalgesicsCanadaChronic DiseaseDouble-Blind Methodgamma-Aminobutyric AcidHospitals, UniversityHumansMaleMiddle AgedPelvic PainPregabalinProstatitisTreatment OutcomeUnited StatesAnalgesicsgamma-Aminobutyric AcidPregabalin

Identifiers

PMID20876412
PMCPMC3767281
OpenAlexW1988988586

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.