Dataset Information

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.

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.

SUBMITTER: Hilton P

PROVIDER: S-EPMC3504983 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundStress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered.Methods/designA multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes.Trial registrationClinical Trials NCT00814749.

Project description:BackgroundStress urinary incontinence worsens living conditions as far as the occupational, social, mental, physical and sexual aspects of a woman's life. Despite its real impact on the everyday lives of millions of women around the world, this problem is still disregarded and treated only as a discomfort associated with personal hygiene. Could this be due to negligence on the part of medical personnel in this matter and perhaps this lack of knowledge and proper information intended for women with stress urinary incontinence? Implementing educational activities to increase knowledge about urinary incontinence will translate into better educated women and earlier implementation of urinary incontinence treatment in the future. To properly educate women at risk of urinary incontinence, one needs to be familiar with the condition, in particular the risk factors for its development. The purpose of the study was to evaluate the degree of knowledge of students graduating from medical faculties have regarding risk factors for stress urinary incontinence in women and assess where the students' knowledge of this problem came from.MethodsThe research involved 1581 final year students of medical faculties: nursing and midwifery (258), medicine (432), physiotherapy (402) and other medical (489). The author's survey was used for the research. The chi2 test was used for analysis.ResultsStudents in faculties of nursing and midwifery, general medicine, physiotherapy, and other medical faculties could correctly list stress urinary incontinence risk factors in 88.8%, 81.7%, 74.4% and 51.9% of their answers respectively (p < 0.01). The most frequently mentioned source of knowledge about stress urinary incontinence was higher level education in 82.6%, 89.8%, 90.0% and 34.4% of the respective groups' replies (p < 0.001).ConclusionsNursing and midwifery students had the greatest theoretical knowledge of stress urinary incontinence, and lesser knowledge was found among general medicine students, while physiotherapy students and students of other medical faculties had the least theoretical knowledge about risk factors for urinary incontinence. It is advisable that more emphasis be placed on educating students about stress urinary incontinence due to their insufficient knowledge, in particular for future doctors and physiotherapists who will have direct contact with patients.

Project description:BackgroundINVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?) was a mixed methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing (IUT) prior to surgery for stress urinary incontinence (SUI) in women. Here we report one of the study's five components, with the specific objectives of (i) exploring the cost-effectiveness of IUT compared with clinical assessment plus non-invasive tests (henceforth described as 'IUT' and 'no IUT' respectively) in women with SUI or stress-predominant mixed urinary incontinence (MUI) prior to surgery, and (ii) determining the expected net gain (ENG) from additional research.MethodsStudy participants were women with SUI or stress-predominant MUI who had failed to respond to conservative treatments recruited from seven UK urogynaecology and female urology units. They were randomised to receive either 'IUT' or 'no IUT' before undergoing further treatment. Data from 218 women were used in the economic analysis. Cost utility, net benefit and value of information (VoI) analyses were performed within a randomised controlled pilot trial. Costs and quality-adjusted life years (QALYs) were estimated over 6 months to determine the incremental cost per QALY of 'IUT' compared to 'no IUT'. Net monetary benefit informed the VoI analysis. The VoI estimated the ENG and optimal sample size for a future definitive trial.ResultsAt 6 months, the mean difference in total average cost was £138 (p?=?0.071) in favour of 'IUT'; there was no difference in QALYs estimated from the SF-12 (difference 0.004; p?=?0.425) and EQ-5D-3L (difference -?0.004; p?=?0.725); therefore, the probability of IUT being cost-effective remains uncertain. The estimated ENG was positive for further research to address this uncertainty with an optimal sample size of 404 women.ConclusionsThis is the largest economic evaluation of IUT. On average, up to 6 months after treatment, 'IUT' may be cost-saving compared to 'no IUT' because of the reduction in surgery following invasive investigation. However, uncertainty remains over the probability of 'IUT' being considered cost-effective, especially in the longer term. The VoI analysis indicated that further research would be of value.Trial registrationISRCTN. ISRCTN71327395. Registered 7 June 2010.