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
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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