An Economic Evaluation of a Web-Based Management Support System for Children With Urinary Incontinence: The eADVICE Trial.

PURPOSE: Children who require specialist outpatient care typically wait substantial periods during which their condition may progress, making treatment more difficult and costly. Timely and effective therapy during this period may reduce the need for lengthy specialist care. This study evaluated the cost-effectiveness of an individualized, evidence-informed, web-based program for children with urinary incontinence awaiting a specialist appointment (Electronic Advice and Diagnosis Via the Internet following Computerized Evaluation [eADVICE]) compared to usual care. eADVICE was supervised by a primary physician and delivered by an embodied conversational agent. MATERIALS AND METHODS: A trial-based cost-effectiveness analysis was performed from the perspective of the health care funder as a substudy of eADVICE, a multicenter, waitlist-controlled, randomized trial. Outcomes measures were incremental cost per incremental change in continence status and quality of life on an intention-to-treat basis. Uncertainty was examined using cost-effectiveness planes, scenarios, and 1-way sensitivity analyses. Costs were valued in 2021 Australian dollars. RESULTS: The use of eADVICE was found to be cost saving and beneficial (dominant) over usual care, with a higher proportion of children dry over 14 days at 6 months (risk difference 0.13; 95%CI 0.02-0.23, P = .03) and mean health care costs reduced by $188 (95%CI $61-$315) per participant. CONCLUSIONS: An individualized, evidence-informed, web-based program delivered by an embodied conversational agent is likely cost saving for children with urinary incontinence awaiting a specialist appointment. The potential economic impact of such a program is favorable and substantial, and may be transferable to outpatient clinic settings for other chronic health conditions.

A Randomized Controlled Trial of a Web-Based Management Support System for Children With Urinary Incontinence: The eADVICE Trial.

PURPOSE: Children referred to specialist outpatient clinics by primary care providers often have long waiting times before being seen. We assessed whether an individualized, web-based, evidence-informed management support for children with urinary incontinence while waiting reduced requests for specialist appointments. MATERIALS AND METHODS: A multicenter, waitlisted randomized controlled trial was conducted for children (5-18 years) with urinary incontinence referred to tertiary pediatric continence clinics. Participants were randomized to the web-based eHealth program electronic Advice and Diagnosis Via the Internet following Computerized Evaluation (eADVICE), which used an embodied conversational agent to engage with the child at the time of referral (intervention) or 6 months later (control). The primary outcome was the proportion of participants requesting a clinic appointment at 6 months. Secondary outcomes included persistent incontinence, and the Paediatric incontinence Questionnaire (PinQ) score. RESULTS: From 2018 to 2020, 239 children enrolled, with 120 randomized to eADVICE and 119 to the control arm. At baseline, participants' mean age was 8.8 years (SD 2.2), 62% were males, mean PinQ score was 5.3 (SD 2.2), 36% had daytime incontinence, and 97% had nocturnal enuresis. At 6 months, 78% of eADVICE participants vs 84% of controls requested a clinic visit (relative risk 0.92, 95% CI 0.79, 1.06, P = .3), and 23% eADVICE participants vs 10% controls were completely dry (relative risk 2.23, 95% CI 1.10, 4.50, P = .03). The adjusted mean PinQ score was 3.5 for eADVICE and 3.9 for controls (MD -0.37, 95% CI -0.71, -0.03, P = .03). CONCLUSIONS: The eADVICE eHealth program for children awaiting specialist appointments doubled the proportion who were dry at 6 months and improved quality of life but did not reduce clinic appointment requests.

Quality of life and psychological aspects in children with overactive bladder treated with parasacral transcutaneous electrical nerve stimulation - A prospective multicenter study.

OBJECTIVE: To assess the impact of parasacral transcutaneous electrical nerve stimulation (parasacral TENS) on quality of life (QoL) and psychological aspects in children treated for overactive bladder (OAB). METHODS: This international, multicenter, prospective cohort study involved individuals of 6-16 years of age under TENS treatment for OAB. The study was conducted between June 2016 and December 2019 in four participating centers: two in Australia, one in Germany and one in Brazil. Patients with anatomical and/or neurological abnormalities of the urinary tract were excluded. Questionnaires were applied before and after parasacral TENS treatment: the Dysfunctional Voiding Symptom Score (DVSS), used in Brazil, or the International Consultation on Incontinence Questionnaire - Pediatric Lower Urinary Tract Symptoms (ICIQ-CLUTS), used in Germany and Australia, to analyze urinary symptoms; the Strengths and Difficulties Questionnaire (SDQ) to assess emotional and behavioral aspects; and the Pediatric Incontinence Questionnaire (PinQ) for bladder-specific Qol. RESULTS: Fifty-three patients (28 girls and 25 boys) with a mean age of 8.64 ± 2.63 years were included. Median DVSS was 11 (range 6-13.5) and 3 (range 0-7), (p < 0.001), and median ICIQ-CLUTS was 12 (range 9-14) and 9 (range 5.7-12), (p < 0.001), before and after treatment, respectively. Median PinQ score decreased from 47.8 (range 38.9-59.7) to 39 (range 29-53.15) following treatment (p = 0.04). Median total SDQ score before and after treatment was 17 (range 13.5-21) and 15 (range 12-21), respectively (p = 0.939). CONCLUSION: Parasacral TENS was associated with a significant improvement in urinary symptoms and QoL; however, there was no change in psychological symptoms, as measured using the SDQ.

An Alarm Watch for Daytime Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVES: Daytime urinary incontinence is disabling and occurs in 17% of school-aged children. Timed-voiding is part of standard therapy. Can an alarm watch to aid timed-voiding improve treatment response to standard therapy? METHODS: The WATCH (Watch with Alarm for Timed-Voiding in Children) study is a randomized controlled trial. Participants were randomly assigned (1:1) to a vibrating alarm or nonalarming watch for 3-months. The primary outcome was the proportion who achieved a complete response (14 consecutive dry days) after 3-months of treatment. Children aged 5 to 13 years who were prescribed timed-voiding for daytime urinary incontinence. RESULTS: Overall, 243 children, with a mean age of 8 years, were enrolled, with 62% girls. At 3-months, the complete response rates were similar between the 2 groups (22% alarm versus 17% control; difference: 5%; 95% confidence interval (CI): -5% to 16%; P = .42). In the alarm group, treatment adherence was higher (40% vs 10%; difference: 30%; 95% CI: 20% to 40%; P < .001), frequency of incontinence was lower (25% dry; 40% had 1-3 wet days per week, 24% had 4-6 wet days per week, and 12% had daily wetting, compared with 19%, 30%, 35%, and 16%, respectively; P =.05), and fewer had abnormal postvoid residual urine volumes (12% vs 24%; difference: -12%; 95% CI: -21% to -1%; P = .04) compared with the control group. Improvement was transient and did not persist 6 months beyond the treatment period. CONCLUSIONS: Alarm watches do not appear to lead to complete resolution of urinary incontinence in children but did promote treatment adherence, normalization of postvoid residual volumes, and reduction in incontinent episodes while being used.

Toilet training children with special needs using a Potty Monkey toy device.

AIM: Toilet training children with special needs can be challenging and can result in long-term consequences if inadequately addressed. This study evaluates the use of a 'Potty Monkey' toy for toilet training children with special needs. METHODS: A pilot study using a 'Potty Monkey' to model timed voiding in children with special needs. We collected parental feedback and examined the experience of families using a 'Potty Monkey' to toilet train their child. Using logistic regression we explored patient factors for association with outcomes. RESULTS: Of 21 children in our study, 15 were male. Age ranged 4-10 years (median 6.3 years). Days that 'Potty Monkey' was used ranged 0-156 (median 22 days). At 6 months, nine children had improved, five were unchanged and four were worse (three were unknown). We found no evidence of association between patient factors (age, gender, days using 'Potty Monkey', baseline toileting ability, Paediatric Incontinence Questionnaire score) and toileting outcome. The experience of families was ambivalent. 10 families reported 'Potty Monkey' had been helpful however many complained it interfered with family schedules. Reasons for the child not responding positively were due to sensory issues, embarrassment and being developmentally not ready. Our study demonstrated the practical challenges of conducting research among children with special needs. CONCLUSION: Although some children's toileting improved after using 'Potty Monkey', we are uncertain 'Potty Monkey' is effective for toilet training children with special needs.

Australian community health practitioners' knowledge and experience with managing urinary incontinence that begins in childhood.

BACKGROUND AND OBJECTIVES: General practitioners (GPs) often see children with enuresis and daytime urinary incontinence, and adults with persistent enuresis. The aim of this study was to assess Australian community health practitioners' knowledge and experiences with managing these conditions. METHOD: Health practitioners were surveyed about their knowledge and experience managing urinary incontinence that begins in childhood. Associations between participant characteristics and knowledge/experience were examined using chi-square tests. RESULTS: The 1495 participants were mostly female, experienced, GPs who worked in a metropolitan area and/or saw patients with incontinence infrequently, but felt knowledgeable and confident about management of incontinence. Correct survey answers were given by 93% of participants for managing enuresis, 81% for daytime urinary incontinence (with 18% choosing inappropriate and potentially dangerous responses), and 61% for managing enuresis that has persisted into adulthood. DISCUSSION: Better education is needed for GPs regarding management of urinary incontinence that begins in childhood, particularly for daytime incontinence in children and enuresis that persists into adulthood.

A randomised controlled trial of a code-word enuresis alarm.

OBJECTIVE: To compare a novel code-word alarm with a commercially available wireless alarm for treating enuresis. SETTING: A tertiary paediatric centre. PATIENTS: Children aged 6-18 with at least 3 wet nights per week in the previous 6 months referred by doctors. OUTCOMES: Primary outcome: the proportion who achieved a full response (14 consecutive dry nights) by 16 weeks. Secondary outcomes: change in frequency of wetting, duration of alarm training, percentage of wet nights that the child woke to the alarm, adherence to treatment, adverse events and satisfaction with treatment. RESULTS: Of the 353 participants, 176 were assigned to the code-word alarm and 177 to control. At 16 weeks, 54% (95% CI 47% to 61%) in the experimental group and 47% (95% CI 40% to 55%) in the control group had achieved a full response (p=0.22), with 74% and 66%, respectively, attaining a 50% or more reduction in wetting frequency (p=0.14). The experimental group woke more often than the control group (median percentage of waking 88% vs 77%, p=0.003) and had a greater reduction in wet nights (median reduction of 10 vs 9 nights per fortnight). Fewer in the experimental group discontinued therapy before achieving a full response (27% vs 37% discontinued, p=0.04). There were no significant differences in relapse rates at 6 months, adverse events or satisfaction between the two alarms. CONCLUSIONS: Although the code-word alarm increased waking, no difference in full response rates was demonstrated between the two alarms. TRIAL REGISTRATION NUMBER: ACTRN12609000070235.

Strategies for increasing recruitment to randomised controlled trials: systematic review.

BACKGROUND: Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs. METHODS AND FINDINGS: A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00-2.18], attendance at an education session [RR 1.14, 95% CI 1.01-1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14-1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11-2.74), and also monetary incentives (RR1.39, 95% CI 1.13-1.64 to RR 1.53, 95% CI 1.28-1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007. CONCLUSION: Recruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis. Please see later in the article for the Editors' Summary.

Antibiotic prophylaxis and recurrent urinary tract infection in children.

BACKGROUND: Antibiotics are widely administered to children with the intention of preventing urinary tract infection, but adequately powered, placebo-controlled trials regarding efficacy are lacking. This study from four Australian centers examined whether low-dose, continuous oral antibiotic therapy prevents urinary tract infection in predisposed children. METHODS: We randomly assigned children under the age of 18 years who had had one or more microbiologically proven urinary tract infections to receive either daily trimethoprim-sulfamethoxazole suspension (as 2 mg of trimethoprim plus 10 mg of sulfamethoxazole per kilogram of body weight) or placebo for 12 months. The primary outcome was microbiologically confirmed symptomatic urinary tract infection. Intention-to-treat analyses were performed with the use of time-to-event data. RESULTS: From December 1998 to March 2007, a total of 576 children (of 780 planned) underwent randomization. The median age at entry was 14 months; 64% of the patients were girls, 42% had known vesicoureteral reflux (at least grade III in 53% of these patients), and 71% were enrolled after the first diagnosis of urinary tract infection. During the study, urinary tract infection developed in 36 of 288 patients (13%) in the group receiving trimethoprim-sulfamethoxazole (antibiotic group) and in 55 of 288 patients (19%) in the placebo group (hazard ratio in the antibiotic group, 0.61; 95% confidence interval, 0.40 to 0.93; P = 0.02 by the log-rank test). In the antibiotic group, the reduction in the absolute risk of urinary tract infection (6 percentage points) appeared to be consistent across all subgroups of patients (P > or = 0.20 for all interactions). CONCLUSIONS: Long-term, low-dose trimethoprim-sulfamethoxazole was associated with a decreased number of urinary tract infections in predisposed children. The treatment effect appeared to be consistent but modest across subgroups. (Australian New Zealand Clinical Trials Registry number, ACTRN12608000470392.)