• Open Access

Assessing professional equipoise and views about a future clinical trial of invasive urodynamics prior to surgery for stress urinary incontinence in women: A survey within a mixed methods feasibility study§††

Authors


  • Robert Pickard led the peer-review process as the Associate Editor responsible for the paper.

  • Conflict of interest: none.

  • §

    Ethical Approval: Favorable ethical opinion was received from Newcastle and North Tyneside No.1 Research Ethics committee on 06/01/2011 (their minute reference: 10/H0906/76).

  • P.H.: No current financial interests; previous chair of NICE Guideline Development Group (GDG) on urinary incontinence (UI) in women; previous member NETSCC-HTA Interventional Procedures Panel, and Clinical Evaluations and Trials Prioritization Group; previous commercial research funding for trials of surgery for stress incontinence from Gynecare (1998–2003) and Gyne Ideas (now Mpathy Medical; 2001–2003). M.L.: No current financial interests; previous member of NICE GDG on UI in women and on lower urinary tract symptoms in men; chair European Association of Urology guideline group on UI. D.G.T.: Consultancy work for Pfizer, Ethicon, Galen; research grants from Ethicon, Astellas. Chair of BSUG Research Committee. Executive Editor of BJOG, Vice-chairman of the Wellbeing of Women Research Advisory Committee. A.B., D.H., E.M., B.B., N.A.: None.

  • Author's Contributions: P.H. is the lead grant holder, he conceived the study, led on the protocol development, questionnaire design and writing the manuscript, and approved the final version for publication. D.H., E.M., B.B., M.L., D.G.T., N.A. are co-holders of the grant, contributed to protocol development and to writing the manuscript, and approved the final version for publication. E.M.: additionally led on questionnaire formatting. A.B., D.H.: additionally undertook the statistical analysis. N.A.: additionally led on the interview study.

  • ††

    “Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://wileyonlinelibrary.com/onlineopen#OnlineOpen_Terms”.

Abstract

Aims

To determine surgeons' views on invasive urodynamic testing (IUT) prior to surgery for stress (SUI) or stress predominant mixed urinary incontinence (MUI).

Methods

Members of British Society of Urogynaecology (BSUG) and British Association of Urological Surgeons Section of Female, Neurological and Urodynamic Urology (BAUS-SFNUU) were sent an email invitation to complete an online “SurveyMonkey® questionnaire regarding their current use of IUT prior to surgical treatment of SUI, their view about the necessity for IUT in various clinical scenarios, and their willingness to randomize patients into a future trial of IUT. A purposive sample of respondents was invited for telephone interview to explore further how they use IUT to inform clinical decisions, and to contextualize questionnaire responses.

Results

There were 176/517 (34%) responses, 106/332 (32%) from gynecologists/urogynecologists and 67/185 (36%) from urologists; all respondents had access to IUT, and 89% currently arrange IUT for most women with SUI or stress predominant MUI. For a variety of scenarios with increasingly complex symptoms the level of individual equipoise (“undecided” about IUT) was very low (1–6%) and community equipoise was, at best, 66:34 (IUT “essential” vs. “unnecessary”) even for the simplest scenario. Nevertheless, 70% rated the research question underlying the proposed studies “very important” or “extremely important;” 60% recorded a “willingness to randomize” score ≥8/10.

Conclusions

Most urogynecologists and urologists consider IUT essential before surgery in SUI with or without other symptoms. Most however recognize the need for further research, and indicated a willingness to recruit into multicenter trials addressing this question. Neurourol. Urodynam. 31:?–?, 2012. © 2012 Wiley Periodicals, Inc.

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