Aims In its 22nd year, the International Consultation on Incontinence Questionnaire (ICIQ) project continues to promote its primary objective; the development and dissemination of patient completed questionnaires for the standardized, high‐quality assessment of urinary, bowel, and vaginal symptoms. The paper gives an update on the ICIQ in the context of current scientific developments of PROM design and regulatory requirements, and plans are outlined for its future direction. Methods An online library of all questionnaires, including over 300 translations has been launched to facilitate access through a semi‐automated registration system. The ICIQ project continues to update its protocol to meet current scientific standards and incorporate methodological advances within PROM development. Results Nineteen psychometrically validated patient‐reported outcome measures (PROMs) are published for use in clinical practice and research, including amongst others, a bladder diary, male and female lower urinary tract symptoms, long term catheter, pad use, and bowel symptom questionnaires. The original ICIQ‐UI Short Form for the assessment of urinary incontinence continues to be the most internationally used questionnaire and has been translated into over 60 languages. New questionnaires which are under development include the ICIQ‐Underactive Bladder and ICIQ‐Satisfaction. We anticipate the new website and online library will further facilitate the ease of dissemination and availability of the questionnaires for clinical practice and research. Conclusion The ICIQ continues to successfully achieve its primary objective. Going forward, a greater focus on promoting routine clinical use and the potential for electronic integration into databases and medical records is envisaged.

Purpose To describe the English-to-Spanish translation process and preliminary psychometric analysis (face validity, cultural adaptation, and test-retest reliability) of the International Consultation on Incontinence Questionnaire – Bowels Module (ICIQ-B) among Chilean colorectal cancer patients. Materials and Methods The face validity was studied with 10 colorectal cancer patients, and the test-retest reliability, with 15 patients, 1 month before and 6 months after cancer surgery. Results Two rounds of translation/back translation resulted in a Spanish version. The English expression open your bowels was translated as defecar, as it is easily understandable in Spanish. The patients reported that the instrument was easy to answer, with clear instructions, and that it was adequate to appraise their health condition. The test-retest reliability was good (Spearman rho [ρ] ≥ 0.842); only item 15a, the Bristol Stool Scale, obtained a moderate correlation (ρ = 0.639). The patients reported a variety of symptoms, including increased bowel movements, nocturnal bowel movements, fecal urgency, and incontinence. Conclusions The first Spanish version of the ICIQ-B was culturally adapted for Chilean colorectal cancer patients, and showed good test-retest reliability. It might be a reference for other Spanish-speaking countries and for patients with other conditions. The ICIQ-B is a robust comprehensive questionnaire for bowel function.

Background Overactive bladder (OAB) is a health burden that needs an Arabic assessment tool. The idea is to validate the Arabic version of the International Consultation on Incontinence Questionnaire-overactive bladder (ICIQ-OAB). Methods A multicenter cross-sectional study carried out between March 2019 and February 2020. The translated ICIQ-OAB was used to assess the 227 patients. The enrolled patients were 112 complaining of symptoms suggestive of OAB, 115 healthy without LUTS symptoms. Additionally, patients with and without BOO symptoms were included. The reliability assessment of the internal consistency was done using Cronbach’s α test. With the aid of Spearman’s correlation coefficient (r), the interdomain associations were assessed. The Mann–Whitney test was used to assess the discrimination validity. Results A high internal consistency between the mean scores of women with and those without OAB as well as BOO groups, Cronbach’s alpha value was 0.82. A strong correlation obviates among whole ICIQ domains in OAB set (P ≤ 0.001). Equally, a high correlation exists among each domain in the BOO group, and Cronbach’s alpha value was 0.82. In comparison with control, highly significant scores exist for all ICIQ-OAB domains and entire points in the BOO as well as OAB sets (P < 0.001). The ICIQ-OAB was found to have good discriminant validity. Conclusion A formulated and approved ICIQ-OAB -Arabic release is a value tool for addressing OAB symptom complex. The easy questionnaire will be a useful tool in grading the bother symptoms in Arabic speaking inhabitant.

Background Stress urinary incontinence is common in men after prostate surgery and can be difficult to improve. Implantation of an artificial urinary sphincter is the most common surgical procedure for persistent stress urinary incontinence, but it requires specialist surgical skills, and revisions may be necessary. In addition, the sphincter is relatively expensive and its operation requires adequate patient dexterity. New surgical approaches include the male synthetic sling, which is emerging as a possible alternative. However, robust comparable data, derived from randomised controlled trials, on the relative safety and efficacy of the male synthetic sling and the artificial urinary sphincter are lacking. Objective We aimed to compare the clinical effectiveness and cost-effectiveness of the male synthetic sling with those of the artificial urinary sphincter surgery in men with persistent stress urinary incontinence after prostate surgery. Design This was a multicentre, non-inferiority randomised controlled trial, with a parallel non-randomised cohort and embedded qualitative component. Randomised controlled trial allocation was carried out by remote web-based randomisation (1 : 1), minimised on previous prostate surgery (radical prostatectomy or transurethral resection of the prostate), radiotherapy (or not, in relation to prostate surgery) and centre. Surgeons and participants were not blind to the treatment received. Non-randomised cohort allocation was participant and/or surgeon preference. Setting The trial was set in 28 UK urological centres in the NHS. Participants Participants were men with urodynamic stress incontinence after prostate surgery for whom surgery was deemed appropriate. Exclusion criteria included previous sling or artificial urinary sphincter surgery, unresolved bladder neck contracture or urethral stricture after prostate surgery, and an inability to give informed consent or complete trial documentation. Interventions We compared male synthetic sling with artificial urinary sphincter. Main outcome measures The clinical primary outcome measure was men’s reports of continence (assessed from questions 3 and 4 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) at 12 months post randomisation (with a non-inferiority margin of 15%). The primary economic outcome was cost-effectiveness (assessed as the incremental cost per quality-adjusted life-year at 24 months post randomisation). Results In total, 380 men were included in the randomised controlled trial (n = 190 in each group), and 99 out of 100 men were included in the non-randomised cohort. In terms of continence, the male sling was non-inferior to the artificial urinary sphincter (intention-to-treat estimated absolute risk difference –0.034, 95% confidence interval –0.117 to 0.048; non-inferiority p = 0.003), indicating a lower success rate in those randomised to receive a sling, but with a confidence interval excluding the non-inferiority margin of –15%. In both groups, treatment resulted in a reduction in incontinence symptoms (as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Between baseline and 12 months’ follow-up, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score fell from 16.1 to 8.7 in the male sling group and from 16.4 to 7.5 in the artificial urinary sphincter group (mean difference for the time point at 12 months 1.30, 95% confidence interval 0.11 to 2.49; p = 0.032). The number of serious adverse events was small (male sling group, n = 8; artificial urinary sphincter group, n = 15; one man in the artificial urinary sphincter group experienced three serious adverse events). Quality-of-life scores improved and satisfaction was high in both groups. Secondary outcomes that showed statistically significant differences favoured the artificial urinary sphincter over the male sling. Outcomes of the non-randomised cohort were similar. The male sling cost less than the artificial sphincter but was associated with a smaller quality-adjusted life-year gain. The incremental cost-effectiveness ratio for male slings compared with an artificial urinary sphincter suggests that there is a cost saving of £425,870 for each quality-adjusted life-year lost. The probability that slings would be cost-effective at a £30,000 willingness-to-pay threshold for a quality-adjusted life-year was 99%. Limitations Follow-up beyond 24 months is not available. More specific surgical/device-related pain outcomes were not included. Conclusions Continence rates improved from baseline, with the male sling non-inferior to the artificial urinary sphincter. Symptoms and quality of life significantly improved in both groups. Men were generally satisfied with both procedures. Overall, secondary and post hoc analyses favoured the artificial urinary sphincter over the male sling. Future work Participant reports of any further surgery, satisfaction and quality of life at 5-year follow-up will inform longer-term outcomes. Administration of an additional pain questionnaire would provide further information on pain levels after both surgeries. Trial registration This trial is registered as ISRCTN49212975. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 36. See the NIHR Journals Library website for further project information.

Background One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3–4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. Methods Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 hours/week or ≥ 15 hours/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within six months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further six months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. Primary outcomes: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. Secondary outcomes: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. Trial registration: ISRCTN33134697