The impact of a bladder training video versus standard urotherapy on quality of life of children with bladder and bowel dysfunction: A randomized controlled trial

doi:10.1016/j.jpurol.2017.06.005

Journal of Pediatric Urology

Volume 13, Issue 4, August 2017, Pages 374.e1-374.e8

https://doi.org/10.1016/j.jpurol.2017.06.005 Get rights and content

Summary

Introduction

Bladder and bowel dysfunction (BBD) can negatively impact the quality of life (QoL) of children. Urotherapy is an accepted treatment option for BBD; however, literature that examines the impact of management options on QoL in this population is scarce.

Objective

To determine whether a bladder training video (BTV) is non-inferior to standard urotherapy (SU) in improving QoL in children with BBD.

Methods

Children aged 5–10 years and who scored ≥11 on the Vancouver Non-Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire (NLUTD/DES) were recruited from a pediatric tertiary care center. Children were excluded with known vesicoureteral reflux; spinal dysraphism; learning disabilities; recent urotherapy; and primary nocturnal enuresis. Quality of life was evaluated using the Pediatric Incontinence Quality-of-Life questionnaire (PinQ). Questionnaires were administered at the baseline and 3-month follow-up clinic visits. Following centralized electronic blocked randomization schemes to guarantee allocation concealment, patients were assigned to receive SU or BTV during their regular clinic visits. An intention-to-treat protocol was followed. Between-group baseline and follow-up QoL scores were compared using paired and unpaired t-tests, and linear regression analysis.

Results

Of the 539 BBD patients who were screened, 173 (32%) were eligible, and 150 (87%) were randomized. Of these, 143 (96%) completed the study, five (3%) were lost to follow-up, and two (1%) withdrew. In total, 140/143 (97%) completed the QoL questionnaire at baseline and follow-up. Mean follow-up time was 3.5 ± 1.1 months for BTV patients and 3.7 ± 1.6 months for SU. At baseline, BTV and SU patients had a mean QoL score of 26.6 ± 13 and 23.8 ± 12, respectively (P = 0.17). Between-group mean change in PinQ scores from baseline was not statistically significant (BTV: 6.25 ± 12.5 vs SU: 3.75 ± 12.2; P = 0.23; Summary Fig.). Significant predictors of positive change in QoL were: higher symptomatology score, with a correlation coefficient of 0.5 (95% CI: 0.2–0.9; P = 0.003), and worse baseline QoL score, with a correlation coefficient of 0.5 (95% CI: 0.4–0.7; P < 0.001). Overall, most patients had improved symptomatology and QoL scores.

Conclusion

Significant and similar QoL changes from baseline to follow-up were observed in both the BTV and SU groups, suggesting that BTV was non-inferior to SU in improving QoL in children with BBD. Quality of life assessment should be considered when evaluating interventions for BBD, as it appears to be an important clinical outcome with which to determine urotherapy success.

Introduction

Bladder and bowel dysfunction (BBD) is one of the most common conditions seen in pediatric urology outpatient clinics, accounting for >40% of referrals [1], [2]. Bladder and bowel dysfunction represents a heterogeneous condition encompassing both lower urinary tract and bowel disturbances [3], triggering symptoms that can negatively affect a child's quality of life (QoL) [4], [5], [6], [7], [8], [9]. While standard urotherapy (SU) is considered to be the primary treatment for BBD, the downside of this intervention is that it often requires repeated and lengthy clinic visits [3], [10]. Standard urotherapy primarily consists of educational strategies provided to families, and includes information regarding normal lower urinary tract function, instruction on bladder training and healthy bladder and bowel habits, documentation of symptoms with diaries, and support and encouragement [3]. However, there is a clear need for alternative management options, which should be evaluated against this benchmark, that employ meaningful clinical outcomes.

The present paper reports on the secondary outcome of quality of life (QoL) as part of the bladder training video (BTV) trial, which sought to evaluate an animated BTV compared to standard individual urotherapy (SU) [11]. In the first paper, it was concluded that BTV was not inferior to SU in reducing bladder/bowel symptoms in children aged 5–10 years, and such an educational tool may be an alternative modality to deliver conservative-based urotherapy consistent with the International Children's Continence Society terminology [3], [11].

Measurement of quality of life (QoL) provides a holistic assessment from the child's perspective of the impact that BBD has on their daily life [12], [13]. Quality of life is recognized as an important health outcome measure in clinical practice and pediatric studies [7], [14], [15], [16], [17]. In addition to having a negative effect on self-esteem, family and peer relationships, BBD has been shown to be a source of shame and embarrassment for children [5], [9]. Despite the recognized need to measure QoL in children with BBD, this variable is not routinely captured. A survey of pediatric continence experts found that 94% of respondents identified a need for routine QoL assessments in children with BBD; however, this was carried out less than one quarter of the time [15]. Indeed, one of the main reasons to devote resources and time to address BBD is to improve QoL and minimize adverse impacts on self-esteem and family life. When a change to SU modality is considered, it is proposed that QoL be considered as an important outcome measure to ensure that the newly proposed modality is comparable to the established norm.

It is believed that the value of an animated educational video on the QoL of children with BBD has not been previously studied. This represents an interesting, novel and theoretically cost-effective intervention for BBD management. Therefore, as part of the BTV trial, the impact of a 7-min animated BTV versus SU on QoL was evaluated in school-aged children with BBD. The hypothesis was that BTV would be similar in improving QoL compared to SU, and that an improved quality of life score would correlate with a lower BBD symptomatology score.

Section snippets

Design

This study was conducted as a post-hoc analysis of a secondary outcome in the setting of a non-inferiority randomized trial. The study design and methods have been previously reported in detail [11] and the trial was registered with ClinicalTrials.gov (#NCT01915004). The primary outcome of the trial was to determine the non-inferiority of BTV in improving symptomatology scores. Changes in QoL were measured as a secondary outcome. The present paper is an extension of the BTV trial [11], and

Results

A total 75 patients were randomized in each arm (BTV and SU), with similar baseline characteristics (Table 1). A total of 140 patients (BTV = 72; SU = 68) completed baseline and follow-up QoL measures, and were included in the final analyses. Two (1%) patients withdrew from the study and five (3%) were lost to follow-up. The mean initial QoL scores were 26.6 ± 13 for BTV and 23.8 ± 12 for SU patients (P = 0.17). The 3-month follow-up mean QoL scores were 20.3 ± 14.7 for BTV and 20 ± 13.4 for SU

Discussion

When evaluating the success of a medical intervention, traditional clinical measures – such as improvement or symptom resolution, mortality and morbidity – are often considered. Assessing QoL complements these established outcomes, becoming essential and expected when comparing treatment modalities that can interfere with patients' wellbeing [15]. It is well established that BBD negatively impacts the QoL of children [4], [8], [9], [12], [19], [20]. This negative impact is similar to other

Conclusion

Urotherapy has a favorable impact on symptoms and QoL in children with BBD. In the setting of a randomized controlled trial, BTV was not inferior to SU in improving QoL scores in children with BBD, and can thus be considered an efficient modality to deliver urotherapy. It is proposed that QoL assessment with a continence-specific tool such as the PinQ should be considered as a key element with which to evaluate urotherapy success along with other more traditional clinical outcomes.

Disclosure

This study was funded $60,000 by the Canadian Urological Association Pfizer Incontinence fellowship.

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Effect of education given to children with enuresis on quality of life
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Citation Excerpt :
Equit et al. (2014) concluded that children who successfully responded to enuresis treatment achieved a significant improvement in their quality of life [11]. Also, some studies found that training using bladder training videos and standard urotherapy were effective in reducing symptoms and improving quality of life [31,32]. In the study, it was found that the quality of life of children with enuresis is lower at baseline.
The quality of life of children diagnosed with enuresis is affected negatively compared with that of healthy children.
This study aimed to evaluate the effect of the education program given within the framework of nursing activities on the quality of life of children diagnosed with enuresis.
The study was conducted on 60 children aged 7–12 years who applied to the urology clinic of a hospital in Turkey and were diagnosed with enuresis. Data were collected using the Pediatric Incontinence Questionnaire (PINQ). Children who met the study criteria were divided into two groups, control and experimental, using the random draw method. Participants in the experimental group were educated by the researcher with using the Enuresis Education Booklet.
Of the 60 children, 43.3% were aged 7–8 years and 63.3% were male. At baseline, the children in the control group revealed a total mean PINQ score of 45.00 ± 11.52, and the total mean PINQ score was 45.80 ± 12.05 at 1 month. At baseline, the children in the experimental group revealed a total mean PINQ score of 47.00 ± 11.88, and the total mean PINQ score of was 32.404 ± 8.62 at 1 month. A measurement carried out in the education and control groups 1 month later showed a statistically significant difference in the total mean PINQ scores (P < 0.001).
Explaining the disease thoroughly to a child created a positive effect on the child's quality of life.
Integrative review and evaluation of quality of life related instruments in pediatric urology
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The initial query of electronic databases and hand searching yielded 5377 unique articles, 101 of which were identified for full-text screening after title and abstract review. Of these, 43 studies were included for data abstraction and 22 unique instruments were identified [9–22, 23–35, 36–55] (PRISMA diagram in Appendix B). Children's median age was 11 years old (IQR 8.3–13.1, mean: 10.5, SD 3.1).
While most paediatric urologists consider patients' quality of life (QOL) important, few actually measure this outcome. Our goal was to assess instruments used in the pediatric urology QOL literature, specifically looking at whether they captured QOL.
We searched MEDLINE and EMBASE for articles with a self-described primary outcome of measuring QOL. All validated QOL instruments in the papers were analyzed by QOL instrument content experts. Instruments were classified as focusing on: Functioning or QOL (Table). The term Functioning focuses on performing activities. QOL captures person's perceptions about their position in life, informed by circumstances, functioning and conditions. QOL instruments were further subdivided into generic QOL, health-related QOL (HRQOL) and disease-specific HRQOL. Only direct patient self-reported QOL instruments were then assessed, since they are the most clinically useful, reliably assessing patients' own perception of their QOL.
Forty-three publications met inclusion criteria (published 1999–2019). Most common conditions included urinary incontinence (16, 37.2%) and kidney transplantation (12, 27.9%). Overall, 22 unique instruments purporting to measure QOL were identified. Looking at the concepts measured by each instrument, nine instruments (40.9%) assessed Functioning. Nine instruments (40.9%) measured a combination of Functioning and QOL. Only the remaining 4 instruments (18.2%) assessed strictly QOL. The 13 instruments assessing any QOL focused on generic QOL (n = 4), HRQOL (n = 3) and disease-specific HRQOL (n = 6). Of the subset of four instruments assessing strictly QOL, and not Functioning, all had patient self-reported versions available: two generic QOL instruments (KINDL, KIDSCREEN), one generic HRQOL (DISABKIDS), and one disease-specific HRQOL (QUALAS).
Thirteen of 43 studies (30.2%) employed more than one instrument. Thirty-eight studies (88.4%) used an instrument measuring Functioning, with 19 (44.1%) measuring only Functioning, not QOL at all. Twenty-four studies (55.8%) used an instrument measuring actual QOL, although 17 (39.5%) used a combined Functioning/QOL instrument. Only nine (20.9%) used a strictly QOL instrument (strictly HRQOL instruments: 4.7%).
We present encouraging evidence of sustained interest in QOL research in pediatric urology and identify areas needing improvement. Selecting appropriate QOL tools requires a working knowledge of their various underlying meanings and purposes. Whether it adequately assess QOL must be considered. We discuss strengths and weaknesses of instruments and a practical approach to QOL instrument selection.
Much of pediatric urology is grounded in improving QOL. Unfortunately, most studies published to date focus on Functioning, rather than young people's perception-based QOL. Future QOL studies should ideally employ validated instruments capturing patient-reported QOL.
Does a serious game increase intrinsic motivation in children receiving urotherapy?
2019, Journal of Pediatric Urology
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A positive treatment outcome is associated with improvement of QoL in all different types of incontinence [4]. Therefore, improved QoL is an important treatment outcome after a child has successfully completed urotherapy [5]. For children suffering from functional DUI, urotherapy is considered the treatment of choice.
Urotherapy is considered the treatment of choice for children suffering daytime urinary incontinence (DUI). Urotherapy intends to improve bladder dysfunction for children with DUI. For children with refractory DUI, an intensive inpatient bladder training program exists, which focuses on relearning, concentration on, and awareness of the bladder. Children's motivation and adherence are key determinants of a successful training outcome. It is hypothesized that motivation endurance throughout the treatment process may be enhanced by a serious game training tool, which could make the training more appealing and rewarding.
The study explores intrinsic motivation in children receiving bladder training for DUI and whether using a serious game improves their intrinsic motivation.
In this pragmatic study, 50 children were allowed to choose among receiving bladder training with (intervention group) or without the application of a serious game (control group). At 4, 8, and 12 weeks of training, children and parents were asked to complete the Intrinsic Motivation Inventory (IMI). Children also completed the Pediatric Urinary Incontinence Quality of Life Tool (PinQ) before the start of the training and 6 months thereafter. At 6-month follow-up, patients were ask to participate in two focus groups, wherein the children discussed how they used the serious game and which improvements they would prefer.
Children who received standard bladder training with the addition of a serious game did not differ in terms of intrinsic motivation from children who underwent standard bladder training only. Training results were equal in both the groups, with 80% good or improved. Incontinence-related quality of life (QoL) improved accordingly.
In contrast to the study expectations, this game did not increase intrinsic motivation. Findings on training and QoL results are consistent with those of previous studies in both interventions. Although a randomized design could have yielded more valid results than this preference-based approach, the latter is more congruent with clinical practice. In contrast to existing bladder diary apps, this game offers a combination of child-friendly instructions, explanation of bladder (dys)function, and keeping a bladder diary. Mobile devices are playing an increasingly important role in health care; therefore, an urotherapy app can be a complementary therapeutic tool.
Most children find it attractive to combine bladder training with a serious game. However, no added value was found regarding intrinsic motivation and training results. All children with persistent DUI in this cohort were highly motivated to complete an intensive bladder training program.
Urotherapy in the treatment of children and adolescents with bladder and bowel dysfunction: a systematic review
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One study compared standard urotherapy with standard urotherapy + anticholinergic therapy.26 Three articles compared standard urotherapy with a traditional approach (individual dialog consultation) with alternative techniques for urotherapy application (video animation and group approach).10,27,28 One article compared symptom reduction in children who received urotherapy shortly after the diagnosis with those who received therapy three months after the diagnosis29 and one article analyzed response to urotherapy at each child's appointment, as well as the percentage of adherence to the return consultations according to the number of visits.30
To identify and describe the protocols and clinical outcomes of urotherapy interventions in children and adolescents with bladder bowel dysfunction.
Systematic review carried out in June 2018 on Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL),Excerpta Medica dataBASE (EMBASE), Scientific Electronic Library Online (SciELO), Cochrane Library, and PsycInfo databases. Clinical trials and quasi-experimental studies carried out in the last ten years in children and/or adolescents with bladder and bowel symptoms and application of at least one component of urotherapy were included.
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Identificar e descrever os protocolos e desfechos clínicos das intervenções de uroterapia em crianças e adolescentes com disfunção vesical e intestinal.
Revisão sistemática realizada em junho de 2018 nas bases Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL),Excerpta Medica dataBASE (EMBASE), Scientific Electronic Library Online (SciELO), Cochrane Library e PsycInfo. Foram incluídos ensaios clínicos e estudos quase-experimentais dos últimos 10 anos, em crianças e/ou adolescentes com sintoma urinário e intestinal e aplicação de no mínimo um componente de uroterapia.
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The impact of a bladder training video versus standard urotherapy on quality of life of children with bladder and bowel dysfunction: A randomized controlled trial

Summary

Introduction

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Design

Results

Discussion

Conclusion

Disclosure

J Pediatr Urol

J Pediatr Urol

Eur Urol

J Pediatr Urol

J Urol

J Urol

J Urol

Recommendations for the management of bladder bowel dysfunction in children

Pediatr Ther

Development of a symptom score for dysfunctional elimination syndrome

J Urol

The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society

Neurourol Urodyn

Self-reported effect of childhood incontinence on quality of life

J Wound Ostomy Cont Nurs