Dataset Information

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

ABSTRACT: Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic.This 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.Of 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.Pregabalin 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.clinicaltrials.gov Identifier: NCT00371033.

SUBMITTER: Pontari MA

PROVIDER: S-EPMC3767281 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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

Pontari Michel A MA Krieger John N JN Litwin Mark S MS White Paige C PC Anderson Rodney U RU McNaughton-Collins Mary M Nickel J Curtis JC Shoskes Daniel A DA Alexander Richard B RB O'Leary Michael M Zeitlin Scott S Chuai Shannon S Landis J Richard JR Cen Liyi L Propert Kathleen J KJ Kusek John W JW Nyberg Leroy M LM Schaeffer Anthony J AJ

Archives of internal medicine 20100901 17

<h4>Background</h4>Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic.<h4>Methods</h4>This 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 we ...[more]

PMID: 20876412

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Project description:ObjectiveExcessive pelvic floor muscle activity has been suggested as a source of pain in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Our objective was to determine whether men with CP/CPPS have changes in neural drive that impair their ability to relax pelvic floor muscles.MethodsWe recruited 90 men (42 with CP/CPPS and 48 in the control group [without a history of pelvic pain]). All completed the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). We quantified the ability to relax by comparing resting pelvic floor muscle activity under 2 conditions: a "rest-only" condition, in which participants were instructed to simply relax, and a "rest-between-contraction" condition, in which participants were instructed to rest for several seconds between voluntary pelvic floor muscle contractions. We used multivariate mixed-effects models to examine differences between the groups (men with CP/CPPS and men in the control group) as well as the effect of 6 symptoms captured by the NIH-CPSI: pain related to location (perineum, testicles, penis, suprapubic region) and activity (urination, ejaculation).ResultsMen with CP/CPPS were significantly different from men in the control group; men with CP/CPPS had higher resting activity in the rest-between-contraction condition than in the rest-only condition, whereas men in the control group had similar resting activities in both conditions. This effect was strongest in men who reported ejaculation-related pain, which was 70% of the CP/CPPS group.ConclusionMen without a history of pelvic pain were able to relax their pelvic floor muscles back to baseline after performing voluntary pelvic floor muscle contractions. In contrast, men with CP/CPPS, particularly those with ejaculation-related pain, had an impaired ability to relax their pelvic floor muscles.ImpactThis study may support the investigation of more personalized physical therapist approaches for CP/CPPS that enhance the ability to relax pelvic floor muscles as a mechanism for pain reduction.

Dataset Information

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

Publications

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

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