Title: Treatment Success for Overactive Bladder with Urinary Urge Incontinence Refractory to Oral Antimuscarinics: A Review of Published Evidence

Transcription

1 Author's response to reviews Title: Treatment Success for Overactive Bladder with Urinary Urge Incontinence Refractory to Oral Antimuscarinics: A Review of Published Evidence Authors: Jonathan D Campbell (campbelj@u.washington.edu) Katharine S Gries (kt04@u.washington.edu) Jonathan H Watanabe (knobby@u.washington.edu) Arliene Ravelo (arlieneravelo@yahoo.com) Roger R Dmochowski (roger.dmochowski@vanderbilt.edu) Sean D Sullivan (sdsull@u.washington.edu) Version: 4 Date: 13 October 2009 Author's response to reviews: see over

2 MS: October 9, 2009 BMC Urology BioMed Central Ltd Middlesex House Cleveland Street London W1T 4LB, UK. Dear Dr Alam: Thank you for your continued interest in our manuscript. My colleagues and I are pleased to present the revised version of the research article, entitled Treatment Success for Overactive Bladder with Urinary Urge Incontinence Refractory to Oral Antimuscarinics: A Review of Published Evidence, for submission to BMC Urology. This is the second revision to the manuscript. We have made every effort to fully address the peer reviewers criticisms (see pages 2-3). We hope you find our revised manuscript acceptable for publication in your journal. Thank you for your consideration. Please contact me with any questions and note my updated contact information. Sincerely, Jonathan D Campbell, PhD Assistant Professor Department of Clinical Pharmacy University of Colorado Denver School of Pharmacy, C238-L E. 17th Ave, Room L Aurora, CO Tel (303) Fax (303) Jon.Campbell@ucdenver.edu 1

3 Referee 2: No further comment to the authors. Referee 3: No further comment to the authors. Referee 1 Version: 3 Date: 19 August 2009 Reviewer: Rufus Cartwright Reviewer's report: This article is substantially improved, in line with all reviewers' comments on the previous version. I have four recommendations only: Mandatory: The search terms given do not appear to find all the articles included. Could the authors give the exact combinations of search terms used, as implied in their comments to reviewer 3. COMMENT: In the review methodology section of the manuscript, we have included the following text to describe in detail the search terms used, Search terms used for retrieval of botulinum toxin studies were botulinum A toxin overactive bladder, sacral neuromodulation were sacral neuromodulation overactive bladder, and surgical treatment studies were augmentation overactive bladder OR clam augmentation. Text in the results section and in Figure 1 specifies the yield of studies found from our searches and additional studies found from published review studies or from references of studies found using the search terms. The search of BoNTA studies yielded 165 abstracts for review (Figure 1). A total of 11 articles met inclusion criteria and an additional 17 articles were retrieved from published reviews or references of accepted articles... The search of SNM studies produced 86 abstracts for review (Figure 1). From these, 4 articles were included and 7 studies came from references of review articles... The search of AC studies produced 51 abstracts for review (Figure 1). A total of 4 studies were included from the search, 3 studies from references of review articles, and 2 studies from references of other accepted studies. Discretionary: The title does not really reflect the two parts of the paper. It should be more apparent, in line with QUORUM and CONSORT recommendations, that this paper includes both a systematic review and a post-hoc analysis of raw data from an RCT. COMMENT: We appreciate this suggestion. The primary objective of this study was to review common treatment success outcomes as reported in the peer- 2

4 reviewed literature. Our secondary objective was to recommend a measure of treatment success for clinical research and health economic applications. Given that our post-hoc analysis of a RCT is not enough to fully validate the recommended treatment success definition, we propose to maintain the current title in order to emphasize the primary objective of this research. The paper would have much more impact if the authors were also to report average change in SF-6D and I-QOL for the complete continence definition. COMMENT: Due to the small sample size in the Schurch et al RCT and the limited number of patients that achieved complete continence at the end of the 24 week study (N=14 across all treatment groups), we decided not to report the SF-6D and I-QOL findings for complete continence. A limitation for using a treatment success definition of complete continence is mentioned in the discussion section: The achievement of full continence has been a common metric in BoNTA studies. But in the case of a dichotomous outcome of success (yes/no), full continence likely excludes many patients that are clinically benefiting from treatment. The question then becomes, what is an appropriate threshold in terms of incontinence reduction that resonates as a clinically meaningful improvement yet does not disregard too many patients that are benefiting? We sought out a definition of success that limits misclassification/residual confounding by setting a threshold that most appropriately includes those receiving meaningful clinical benefit while excluding those that experience a measurable benefit that is not clinically relevant. The authors might like to cite the recent paper by Yalcin et al "Reductions in stress urinary incontinence episodes: What is clinically important for Women?", which provides further support for their recommended definition. COMMENT: Thank you for this suggestion. We have included the Yalcin et al citation in the discussion section. The following text was added, Additionally, Yalcin et al reported that stress urinary incontinence patients appear to recognize important clinical value at incontinence reductions of approximately 50% [1]. 3

5 References 1. Yalcin I, Peng G, Viktrup L, Bump RC: Reductions in stress urinary incontinence episodes: What is clinically important for Women? Neurourol Urodyn