Process for Development of Multicenter Urodynamic Studies

Charles W. Nager, Michael E. Albo, Mary P. FitzGerald, Susan M. McDermott, Stephen Kraus, Holly E. Richter, Philippe Zimmern

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

Objectives: To describe our experiences with a continuous quality improvement process for the standardization of multicenter urodynamic studies (UDSs) in a multi-institutional network. Multicenter UDSs can have considerable variations in testing procedures, training, equipment, and reviewer biases. Methods: A quality control process was developed that included protocol development, certification of urodynamic testers, central review to assess compliance with protocol and quality, protocol modifications, standardization of equipment and signal configuration, development of an electronic signal repository, and the development of UDS Interpretation Guidelines. Results: We describe our experience and process in the development and implementation of a standardized UDS protocol in a multicenter surgical trial for stress urinary incontinence. The process included our protocol development, quality control measures, standardization processes, electronic signal repository, and the need for UDS Interpretation Guidelines. A urodynamic testing procedures protocol was implemented successfully by 20 urodynamic testers at nine continence treatment centers. The protocol provides explicit and detailed guidelines for equipment, calibration, patient position, specific annotations, lay language bladder sensation parameters, visual leak point pressure techniques, modifications for prolapse, and data recording. A UDS Interpretation Guidelines document provides specific suggestions for validity and plausibility determination, expected ranges of urodynamic variables, and reasonable agreement of measuring systems. Both documents are available to urodynamic investigators on the Urinary Incontinence Treatment Network website (http://www.uitn.net/resourcesforphysicians.htm). Conclusions: Multicenter UDSs require a continuous quality improvement process and the development of UDS testing procedures and interpretation guidelines.

Original languageEnglish (US)
Pages (from-to)63-67
Number of pages5
JournalUrology
Volume69
Issue number1
DOIs
StatePublished - Jan 2007

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Urodynamics
Multicenter Studies
Guidelines
Quality Improvement
Quality Control
Equipment and Supplies
Guideline Adherence
Stress Urinary Incontinence
Process Assessment (Health Care)
Prolapse
Certification
Urinary Incontinence
Calibration
Urinary Bladder
Language

ASJC Scopus subject areas

  • Urology

Cite this

Nager, C. W., Albo, M. E., FitzGerald, M. P., McDermott, S. M., Kraus, S., Richter, H. E., & Zimmern, P. (2007). Process for Development of Multicenter Urodynamic Studies. Urology, 69(1), 63-67. https://doi.org/10.1016/j.urology.2006.08.1118

Process for Development of Multicenter Urodynamic Studies. / Nager, Charles W.; Albo, Michael E.; FitzGerald, Mary P.; McDermott, Susan M.; Kraus, Stephen; Richter, Holly E.; Zimmern, Philippe.

In: Urology, Vol. 69, No. 1, 01.2007, p. 63-67.

Research output: Contribution to journalArticle

Nager, CW, Albo, ME, FitzGerald, MP, McDermott, SM, Kraus, S, Richter, HE & Zimmern, P 2007, 'Process for Development of Multicenter Urodynamic Studies', Urology, vol. 69, no. 1, pp. 63-67. https://doi.org/10.1016/j.urology.2006.08.1118
Nager CW, Albo ME, FitzGerald MP, McDermott SM, Kraus S, Richter HE et al. Process for Development of Multicenter Urodynamic Studies. Urology. 2007 Jan;69(1):63-67. https://doi.org/10.1016/j.urology.2006.08.1118
Nager, Charles W. ; Albo, Michael E. ; FitzGerald, Mary P. ; McDermott, Susan M. ; Kraus, Stephen ; Richter, Holly E. ; Zimmern, Philippe. / Process for Development of Multicenter Urodynamic Studies. In: Urology. 2007 ; Vol. 69, No. 1. pp. 63-67.
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