Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.

Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.

BACKGROUND: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. METHODS: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. DISCUSSION: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial.

INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.

Could the National Institute for Health and Clinical Excellence guidelines on urodynamics in urinary incontinence put some women at risk of a bad outcome from stress incontinence surgery?

OBJECTIVE: To evaluate the potential impact of the UK National Institute for Health and Clinical Excellence (NICE) recommendation that preoperative urodynamics are not necessary for women with 'pure symptoms of stress urinary incontinence' (SUI), by using data from a population of women referred with lower urinary tract symptoms. PATIENTS AND METHODS: In a retrospective study of 6276 women with UI, from an electronic database at a tertiary referral centre, information was collected and entered into a urodynamics computer database at the time of history taking and before conducting the tests. The database was used to identify women aged 18-80 years who had multichannel cystometry for UI over a 17-year period (1 January 1990 to 31 December 2006). To apply the NICE criterion of a 'clearly defined clinical diagnosis of pure SUI', strict selection criteria were used to identify patients with pure SUI. The reliability of the patients' history in predicting 'pure' urodynamic SUI in patients with 'pure' SUI was investigated. The correspondence of the symptomatic diagnosis of pure SUI with the urodynamic findings was assessed, and sensitivity, specificity, positive and negative predictive values were calculated using contingency tables. RESULTS: Only 324 (5.2%) women had pure SUI; moreover, a quarter of those with pure SUI symptoms ultimately had urodynamic diagnoses other than urodynamic SUI, that could affect the outcome of continence surgery. CONCLUSION: These findings indicate that only a small group of women fulfil the NICE criteria of pure SUI. These strict criteria do not ensure that all women with potentially important urodynamic findings are evaluated accordingly. Therefore, we suggest that this NICE recommendation was unwise and, furthermore, was not based on properly acquired expert opinion.