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J Urol. 2016 Nov;196(5):1450-1455. doi: 10.1016/j.juro.2016.04.070. Epub 2016 Apr 27.

Symptom Variability and Early Symptom Regression in the MAPP Study: A Prospective Study of Urological Chronic Pelvic Pain Syndrome.

Collaborators (137)

Clemens JQ, Hanno P, Kirkali Z, Kusek JW, Landis JR, Lucia MS, Moldwin RM, Mullins C, Pontari MA, Klumpp DJ, Schaeffer AJ, Apkarian AV, Cella D, Farmer MA, Fitzgerald C, Gershon R, Griffith JW, Heckman CJ 2nd, Jiang M, Keefer L, Marko DS, Michniewicz J, Parrish T, Tu F, Mayer EA, Rodríguez LV, Alger J, Ashe-McNalley CP, Ellingson B, Heendeniya N, Kilpatrick L, Kulbacki C, Kutch J, Labus JS, Naliboff BD, Randal F, Smith SR, Kreder KJ, Bradley CS, Eno M, Greiner K, Luo Y, Lutgendorf SK, O'Donnell MA, Ziegler B, Clauw DJ, Clemens JQ, As-Sanie S, Berry S, Grayhack C, Halvorson ME, Harris R, Harte S, Ichesco E, Oldendorf A, Scott KA, Williams DA, Buchwald D, Afari N, Krieger J, Miller J, Richey S, Robertson K, Ross SO, Spiro R, Sundsvold TJ, Strachan E, Yang CC, Andriole GL, Lai HH, Bristol RL, Colditz G, Deutsch G, Gardner VC, Gereau RW 4th, Henderson JP, Hong BA, Hooton TM, Ness TJ, North CS, Spitznagle TM, Sutcliffe S, Anger J, Freeman M, Kim J, Eilber K, Van Eyk J, Yang W, Funari V, Cha J, Landis JR, Barrell T, Hanno P, Doe RP, Farrar JT, Gallagher L, Hou X, Jemielita T, Howard T, Pontari MA, Robinson N, Smith S, Stephens A, Wang Y, Wang X, Lucia MS, van Bokhoven A, Osypuk AA, Dayton R Jr, Jonscher KR, Sullivan HT, Wilson RS, Moses MA, Briscoe AC, Briscoe D, Curatolo A, Froehlich J, Lee RS, Sachdev M, Solomon KR, Steen H, Mackey S, Bagarinao E, Foster LC, Hubbard E, Johnson KA, Martucci KT, McCue RL, Moericke RR, Nilakantan A, Noor N, Nickel JC, Ehrlich GD, Mullins C, Kusek JW, Kirkali Z, Bavendam TG.

Author information

1
Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: alisaste@mail.med.upenn.edu.
2
Department of Urology, University of Michigan, Ann Arbor, Michigan.
3
Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
4
Department of Surgery, Washington University, St. Louis, Missouri.
5
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania.

Abstract

PURPOSE:

We examined symptom variability in men and women with urological chronic pelvic pain syndrome. We describe symptom fluctuations as related to early symptom regression and its effect on estimated 1-year symptom change. We also describe a method to quantify patient specific symptom variability.

MATERIALS AND METHODS:

Symptoms were assessed biweekly in 424 subjects with urological chronic pelvic pain syndrome during 1 year. To evaluate the impact of early symptom regression subjects were classified as improved, no change or worse according to the rate of change using 1) all data, 2) excluding week 0 and 3) excluding weeks 0 and 2. Patient specific, time varying variability was calculated at each interval using a sliding window approach. Patients were classified as high, medium or low variability at each time and ultimately as high or low variability overall based on the variability for the majority of contacts.

RESULTS:

Prior to excluding early weeks to adjust for early symptom regression 25% to 38% and 5% to 6% of patients were classified as improved and worse, respectively. After adjustment the percent of patients who were improved or worse ranged from 15% to 25% and 6% to 9%, respectively. High and low variability phenotypes were each identified in 25% to 30% of participants.

CONCLUSIONS:

Patients with urological chronic pelvic pain syndrome show symptom variability. At study enrollment patients had worse symptoms on average, resulting in a regression effect that influenced the estimated proportion of those who were improved or worse. Prospective studies should include a run-in period to account for regression to the mean and other causes of early symptom regression. Further, symptom variability may be quantified and used to characterize longitudinal symptom profiles of urological chronic pelvic pain syndrome.

KEYWORDS:

cystitis; epidemiologic research design; interstitial; pain; prostate; symptom assessment

PMID:
27131464
PMCID:
PMC5069105
DOI:
10.1016/j.juro.2016.04.070
[Indexed for MEDLINE]
Free PMC Article

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