Document Detail


Variability of urodynamic parameters in patients with overactive bladder.
MedLine Citation:
PMID:  21674594     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: To report interpatient, intrapatient, and study site variability of urodynamic study (UDS) parameters in patients with overactive bladder (OAB).
METHODS: Fifty-eight patients with OAB participated in a randomized, double-blind, placebo-controlled, urodynamic trial of an experimental OAB drug. Patients underwent 3 serial cystometries (CMGs) at three times: screening, pre-dose, and 4-hr postdose. This post hoc analysis describes intrapatient, interpatient, and site variability for the 6 CMGs prior to administration of study drug. Sites were given standard procedures for equipment calibration and UDS technique. Instilled volumes and pressures were recorded at first sensation of filling, first desire to void (FDV), strong desire to void (SDV), and maximum cystometric capacity (MCC).
RESULTS: The UDS volume endpoint with the smallest observed within-patient variability based on coefficient of variation (%CV) was MCC (%CV 24). Pressure measurements of all bladder sensations had larger within-patient variability than volume (MCC %CV 105). The between-patient variability was greater than within-patient variability for all bladder sensation volumes. Between-patient MCC variability for the 6 pre-treatment CMGs ranged from %CV of 50 to 58, whereas the within-patient %CV for MCC was 21-23. Excellent reproducibility was observed for bladder volume for MCC (intraclass correlation coefficients, range: 0.80-0.84). The between-site variability was large, as demonstrated by the mean volumes by site for MCC (132-397  ml).
CONCLUSIONS: MCC was the most reproducible sensation. Pressure measurements were substantially more variable than volume. Between-patient variability was substantially greater than within-patient variability. The observed intersite variability suggests that despite detailed instructions, sensations may not have been measured in a consistent manner across sites.
Authors:
Tara L Frenkl; Radha Railkar; John Palcza; Boyd B Scott; Achilles Alon; Stuart Green; Werner Schaefer
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2011-06-14
Journal Detail:
Title:  Neurourology and urodynamics     Volume:  30     ISSN:  1520-6777     ISO Abbreviation:  Neurourol. Urodyn.     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-10-20     Completed Date:  2012-02-10     Revised Date:  2012-05-29    
Medline Journal Info:
Nlm Unique ID:  8303326     Medline TA:  Neurourol Urodyn     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1565-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Wiley Periodicals, Inc.
Affiliation:
Merck Research Laboratories, Rahway, New Jersey, USA. tara_frenkl@merck.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Calibration
Diagnostic Techniques, Urological* / standards
Double-Blind Method
Female
Humans
Middle Aged
Observer Variation
Placebos
Predictive Value of Tests
Pressure
Reproducibility of Results
Sensation
Treatment Outcome
United States
Urinary Bladder / drug effects,  innervation,  physiopathology*
Urinary Bladder, Overactive / diagnosis*,  drug therapy,  physiopathology
Urodynamics*
Young Adult
Chemical
Reg. No./Substance:
0/Placebos
Comments/Corrections
Comment In:
Neurourol Urodyn. 2012 Apr;31(4):605; author reply 606   [PMID:  22275245 ]
Neurourol Urodyn. 2011 Nov;30(8):1570   [PMID:  21717497 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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