Urodynamic studies for management of urinary incontinence in children and adults

Clement, Keiran; Lapitan, Marie Carmela; Omar, Muhammad Imran; Glazener, Cathryn

doi:10.1002/14651858.cd003195.pub3

Cited by 49 publications

(31 citation statements)

References 84 publications

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“…We identified a change in planned treatment for 19% of the women randomised to the invasive urodynamic testing arm (compared with 4% in the no IUT arm). This confirms that undergoing invasive urodynamic testing does influence practice, and is in keeping with some other studies in this area, 39,42,92 albeit the results have not been consistent across all studies. 36 Based on the outcome measures reported for the women at 6 months, the pilot trial suggests that there is a small difference in outcome as a result of this change in practice.…”

Section: Key Messagessupporting

confidence: 80%

“…The most recent review was undertaken during the course of the INVESTIGATE-I study, and included two new trials. [34][35][36]39 A pre-publication version of this review was shared with the current authors, 42 and one of the authors of the Cochrane review, a member of the INVESTIGATE-I TSC, agreed to incorporate outcomes from the pilot trial into appropriate meta-analyses. The following outcomes were incorporated:…”

Section: Results Integrated Into Cochrane Meta-analysismentioning

confidence: 99%

“…The authors' conclusions from the Cochrane review included the following: 42 When women with incontinence are assessed using urodynamics in addition to clinical methods, they are more likely to receive different treatment, and to have their management plan changed. However, the evidence was not conclusive in showing whether these differences in management resulted in differences in health outcomes, such as incontinence, quality of life or economic outcomes after treatment compared to women who did not have urodynamic tests.…”

Section: Results Integrated Into Cochrane Meta-analysismentioning

confidence: 99%

“…Since designing the feasibility study, the most recent Cochrane review of urodynamics in adults and children indicates that a similarly large sample size would be required to address this question. 42 Given the possible size of a definitive trial on this question therefore, a feasibility study was considered crucial to test assumptions made, give relevant estimates of key parameters and inform power calculations for the definitive trial.…”

Section: 18mentioning

confidence: 99%

See 3 more Smart Citations

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: Key Messagessupporting

confidence: 80%

Section: Results Integrated Into Cochrane Meta-analysismentioning

confidence: 99%

Section: Results Integrated Into Cochrane Meta-analysismentioning

confidence: 99%

Section: 18mentioning

confidence: 99%

See 2 more Smart Citations

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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show abstract

“…However, this study was retrospective, and further randomized trials are required to determine whether preoperative urodynamic testing results in better clinical outcomes. 13 Urodynamic testing before POP or urinary incontinence surgery may result in changes to treatment plans, exclude disadvantageous factors and provide additional information to provide to patients when seeking informed consent.…”

Section: Discussionmentioning

confidence: 99%

Impact of preoperative urodynamic testing for urinary incontinence and pelvic organ prolapse on clinical management in Chinese women

Liang

Ling

et al. 2015

J of Obstet and Gynaecol

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Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women

Dumoulin

Hay‐Smith

Habée‐Séguin

2014

Cochrane Database of Systematic Reviews

443

202

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BackgroundPelvic floor muscle training is the most commonly used physical therapy treatment for women with stress urinary incontinence. It is sometimes recommended for mixed and less commonly urge urinary incontinence. ObjectivesTo determine the effects of pelvic floor muscle training for women with urinary incontinence in comparison to no treatment, placebo or sham treatments, or other inactive control treatments. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women (Review)

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Urodynamic studies for management of urinary incontinence in children and adults

Cited by 49 publications

References 84 publications

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

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

Impact of preoperative urodynamic testing for urinary incontinence and pelvic organ prolapse on clinical management in Chinese women

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women

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