Value of Urodynamics Before Stress Urinary Incontinence Surgery

Leijsen, Sanne A. L. van; Kluivers, Kirsten B.; Mol, Ben Willem J.; Hout, Joanna In 'T; Milani, Alfredo L.; Roovers, Jan Paul; Boon, Jan den; Vaart, C. H. van der; Langen, Paul H.; Hartog, Francis E.; Dietz, Viviane; Tiersma, E. Stella M.; Hovius, Marina C.; Bongers, Marlies Y.; Spaans, Wilbert; Heesakkers, John; Vierhout, Mark E.

doi:10.1097/aog.0b013e31828c68e3

Cited by 105 publications

(80 citation statements)

References 32 publications

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“…Each of these studies has been published during the period of recruitment and follow-up in INVESTIGATE-I; 35,36,39 their results are discussed later in this report. How much they have already influenced clinical opinion and practice or will do so in the future is unclear, although a 'point-counterpoint' debate published after these studies (in 2013) makes it clear that there is still a question to be answered.…”

Section: 18mentioning

confidence: 99%

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INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women

Hilton

Armstrong

Brennand

et al. 2015

Health Technology Assessment

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BackgroundThe position of invasive urodynamic testing in the diagnostic pathway for urinary incontinence (UI) is unclear. Systematic reviews have called for further trials evaluating clinical utility, although a preliminary feasibility study was considered appropriate.ObjectivesTo inform the decision whether or not to proceed to a definitive randomised trial of invasive urodynamic testing compared with clinical assessment with non-invasive tests, prior to surgery in women with stress UI (SUI) or stress predominant mixed UI (MUI).DesignA mixed-methods study comprising a pragmatic multicentre randomised pilot trial; economic evaluation; survey of clinicians’ views about invasive urodynamic testing; qualitative interviews with clinicians and trial participants.SettingUrogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees.ParticipantsTrial recruits were women with SUI or stress predominant MUI who were considering surgery after unsuccessful conservative treatment. Relevant clinicians completed two online surveys. Subsets of survey respondents and trial participants took part in separate qualitative interview studies.InterventionsPilot trial participants were randomised to undergo clinical assessment with non-invasive tests (control arm); or assessment as controls, plus invasive urodynamic testing (intervention arm).Main outcome measuresConfirmation that units can identify and recruit eligible women; acceptability of investigation strategies and data collection tools; acquisition of outcome data to determine the sample size for a definitive trial. The proposed primary outcome for the definitive trial was International Consultation on Incontinence Modular Questionnaire (ICIQ) Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (total score) 6 months after surgery or the start of non-surgical treatment; secondary outcomes included: ICIQ-FLUTS (subscales); ICIQ Urinary Incontinence Short Form; ICIQ Lower Urinary Tract Symptoms Quality of Life; Urogenital Distress Inventory; EuroQol-5D; costs, quality-adjusted life-years (QALYs) and incremental cost per QALY, Short Form 12; 3-day bladder diary.ResultsOf 284 eligible women, 222 (78%) were recruited; 165/219 (75%) returned questionnaires at baseline and 125/200 (63%) who were sent questionnaires at follow-up. There were few missing data items in returned questionnaires, with individual outcome scales calculable for 81%–94%. Most women underwent surgery; management plans were changed in 19 (19%) participants following invasive urodynamic testing. Participant Costs Questionnaires were returned by 53% 6 months after treatment; complete data to undertake cost–utility analysis were available in 27% (intervention) and 47% (control). While insufficient to recommend changes in practice, the results suggest further research would be valuable. All clinicians responding to the survey had access to invasive urodynamic testing, and most saw it as essential prior to surgery in women with SUI with or without other symptoms; nevertheless, 70% considered the research question underlying INVESTIGATE important and most were willing to randomise patients in a definitive trial. Participants interviewed were positive about the trial and associated documentation; the desire of some women to avoid invasive urodynamic testing contrasted with opinions expressed by clinicians through both survey and interview responses.ConclusionsAll elements of a definitive trial and economic evaluation were rehearsed; several areas for protocol modification were identified. Such a trial would require to 400–900 participants, depending on the difference in primary outcome sought.Future workA definitive trial of invasive urodynamic testing versus clinical assessment prior to surgery for SUI or stress predominant MUI should be undertaken.Trial registrationCurrent Controlled Trials ISRCTN71327395.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: 18mentioning

confidence: 99%

“…A brief second survey was undertaken towards the end of the study to assess changes in clinical opinion over time as a result of other publications in the area. 35,36,39 4. Qualitative interviews with a subset of surgeons (see Chapter 6).…”

Section: Study Componentsmentioning

confidence: 99%

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women

Hilton

Armstrong

Brennand

et al. 2015

Health Technology Assessment

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“…The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) trial was a multicenter noninferiority, randomized, controlled trial of a similar patient group in the Netherlands with a slightly different design and the results complement the ValUE study [34]. A total of 578 participants underwent urodynamics and 268 women with discordant findings were approached for consent; 126 agreed and were randomized to immediate surgery (n=64) or individually tailored therapy (n=62).…”

Section: Randomized Trials Of Urodynamic Testing Before Stress Incontmentioning

confidence: 99%

Role of Urodynamics in the Evaluation of Urinary Incontinence and Prolapse

Nager

2013

Curr Obstet Gynecol Rep

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Urodynamics are functional tests of the bladder that are commonly requested for the evaluation of urinary incontinence and prolapse. As a diagnostic test that also can provide prognostic information, urodynamics should be requested when there is a specific question that needs to be answered. This chapter will review the literature that pertains to the common reasons for requesting urodynamics before stress urinary incontinence surgery and review recent randomized trials on urodynamic testing before stress incontinence surgery. In addition, the chapter will compare the predictive ability of urodynamic prolapse reduction stress testing with office-based prolapse reduction stress testing for detecting postoperative stress urinary incontinence in women without symptoms of stress urinary incontinence undergoing prolapse surgery.

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“…The three recent randomized control studies [3][4][5] based on doctors' choice have demonstrated that the group of clinicians involved did not actually use urodynamics in their decisionmaking and essentially all patients ended up with a midurethral sling. Therefore, the negative outcome is given in advance (whether valid or not) because of the design.…”

mentioning

confidence: 99%