Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered

Leijsen, Sanne A. L. van; Kluivers, Kirsten B.; Mol, Ben Willem J.; Broekhuis, Suzan R.; Milani, Fred; Vaart, Huub C. van der; Roovers, Jan Paul; Bongers, Marlies Y.; Boon, Jan den; Spaans, Wilbert; Leeuw, J.W. de; Dietz, Viviane; Kleinjan, Jan H.; Brölmann, Hans A.M.; Roos, Eveline J.; Schaafstra, Judith; Heesakkers, John; Vierhout, Mark E.

doi:10.1186/1472-6874-9-22

Cited by 38 publications

(33 citation statements)

References 14 publications

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“…Additional clinical trials addressing this are under way. 17 In our study the most common diagnosis at UDS was SUI, although we did not specifically determine how many women with SUI in the population underwent UDS preoperatively.…”

Section: Discussionmentioning

confidence: 86%

Patterns and Predictors of Urodynamics Use in the United States

et al. 2013

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Purpose Due to the paucity of data on urodynamics on the national level, we assessed the use of urodynamics in a large sample of individuals in the United States and identified predictors of increased complexity of urodynamic procedures. Materials and Methods Using administrative health care claims for adults enrolled in private insurance plans in the United States from 2002 to 2007, we identified those who underwent cystometrogram and abstracted relevant demographic and clinical data. We used logistic regression to identify predictors of higher urodynamic complexity over basic cystometrogram, specifically cystometrogram plus pressure flow study and videourodynamics. Results We identified 16,574 urodynamic studies, of which 23% were cystometrograms, 71% were cystometrograms plus pressure flow studies and 6% were videourodynamics. Stress incontinence was the most common clinical condition for all studies (33.7%), cystometrogram (30.8%), cystometrogram plus pressure flow study (35.4%) and videourodynamics (24.4%). Urologists performed 59.8% of all urodynamics and gynecologists performed 35.5%. Providers with 14 or more urodynamic studies during the study period performed 75% of all urodynamics and were more likely to perform cystometrogram plus pressure flow study and videourodynamics. On regression analysis the most consistent predictors of cystometrogram plus pressure flow study and/or videourodynamics over cystometrogram were specialty (urologist) and the number of urodynamic tests performed by the provider. Conclusions Most urodynamics in this series consisted of cystometrogram plus pressure flow study with stress incontinence the most common diagnosis. However, regardless of diagnosis, urologists and providers who performed more urodynamics were more likely to perform pressure flow study and/or videourodynamics in addition to cystometrogram. Further research is needed to determine whether these differences reflect gaps in the consistency or appropriateness of using urodynamics.

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Section: Discussionmentioning

confidence: 86%

Patterns and Predictors of Urodynamics Use in the United States

et al. 2013

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“…a slightly different patient group from INVESTIGATE-I), were randomised to either no further assessment or to undergo urodynamic investigation (as in INVESTIGATE-I). In view of the recruitment difficulties with VUSIS-1, the Netherlands group proceeded to a further study of alternative design (VUSIS-2; www.controlled-trials.com/mrct/trial/474127/vierhout), 37 in which all women underwent invasive urodynamic testing, and only those with discordant clinical and urodynamic findings were randomised between surgical treatment (as dictated by their clinical assessment) and individual treatment (dictated by the combination of clinical and urodynamic results); neither participants nor health-care professionals involved were blinded to the urodynamic results in either group.…”

Section: 18mentioning

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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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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“…The utility of performing urodynamic studies (UDS) before anti-incontinence surgery has rarely been studied in a systematic fashion [1]. Some argue that urodynamic evaluation is invasive [2], costly, and does not change clinical decision making [3].…”

Section: Introductionmentioning

confidence: 99%