J G Blaivas1. 1. New York Hospital, Cornell Medical Center, New York, USA.
Abstract
UNLABELLED: OBJECTIVES; To discuss the rudiments of data that need to be collected in order to develop validated, reproducible, well-accepted efficacy instruments for assessing treatment outcomes in urinary incontinence (UI). METHODS: Information is presented from two reports issued by the Urodynamics Society: "Definition and Classification of Urinary Incontinence" and "Standards of Efficacy for Evaluation of Treatment Outcomes in Urinary Incontinence." RESULTS: Instruments to assess the efficacy of treatment should be reliable and valid. Such instruments include structured histories, questionnaires, structured physical examinations, urodynamics, voiding diaries, and pad tests. Recommended primary outcome variables include the number of incontinent episodes, volume of urinary loss, and type of incontinence. Secondary measures include patient satisfaction, quality of life, bladder symptoms, uroflow, postvoid residual urine, and other urodynamic variables. General considerations for the development of clinical trials include 1) using a standard lexicon, 2) consistent timing of follow-up, 3) proper outcome assessment at each follow-up, 4) proper data collection, 5) proper data analysis, and 6) formulating conclusions that are supported by the data. CONCLUSIONS: At the present time, there are no validated, reproducible, well-accepted efficacy instruments for assessing treatment outcomes in UI. Further work directed toward the development of such instruments is warranted.
UNLABELLED: OBJECTIVES; To discuss the rudiments of data that need to be collected in order to develop validated, reproducible, well-accepted efficacy instruments for assessing treatment outcomes in urinary incontinence (UI). METHODS: Information is presented from two reports issued by the Urodynamics Society: "Definition and Classification of Urinary Incontinence" and "Standards of Efficacy for Evaluation of Treatment Outcomes in Urinary Incontinence." RESULTS: Instruments to assess the efficacy of treatment should be reliable and valid. Such instruments include structured histories, questionnaires, structured physical examinations, urodynamics, voiding diaries, and pad tests. Recommended primary outcome variables include the number of incontinent episodes, volume of urinary loss, and type of incontinence. Secondary measures include patient satisfaction, quality of life, bladder symptoms, uroflow, postvoid residual urine, and other urodynamic variables. General considerations for the development of clinical trials include 1) using a standard lexicon, 2) consistent timing of follow-up, 3) proper outcome assessment at each follow-up, 4) proper data collection, 5) proper data analysis, and 6) formulating conclusions that are supported by the data. CONCLUSIONS: At the present time, there are no validated, reproducible, well-accepted efficacy instruments for assessing treatment outcomes in UI. Further work directed toward the development of such instruments is warranted.
Authors: Pierre Collinet; Calin Ciofu; Pierre Costa; Michel Cosson; Bruno Deval; Philippe Grise; Bernard Jacquetin; Francois Haab Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2008-01-15
Authors: Pytha Albers-Heitner; Bary Berghmans; Manuela Joore; Toine Lagro-Janssen; Johan Severens; Fred Nieman; Ron Winkens Journal: BMC Health Serv Res Date: 2008-04-15 Impact factor: 2.655