Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial.

OBJECTIVE: The long-term efficacy and safety of polyethylene glycol (PEG) in constipated children are unknown, and a head-to-head comparison of the different PEG formulations is lacking. We aimed to investigate noninferiority of PEG3350 with electrolytes (PEG3350 + E) compared to PEG4000 without electrolytes (PEG4000). METHODS: In this double-blind trial, children aged 0.5 to 16 years with constipation, defined as a defecation frequency of <3 times per week, were randomized to receive either PEG3350 + E or PEG4000. Primary outcomes were change in total sum score (TSS) at week 52 compared to baseline, and dose range determination. TSS was the sum of the severity of 5 constipation symptoms rated on a 4-point scale (0-3). Noninferiority margin was a difference in TSS of ≤1.5 based on a 95%-confidence interval [CI]. Treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence. RESULTS: Ninety-seven subjects were included, of whom 82 completed the study. Mean reduction in TSS was -3.81 (95% CI: -4.96 to -2.65) and -3.74 (95%CI: -5.08 to -2.40), for PEG3350 + E and PEG4000, respectively. Noninferiority criteria were not met (maximum difference between groups: -1.81 to 1.68). Daily sachet use was: 0 to 2 years: 0.4 to 2.3 and 0.9 to 2.1; 2 to 4 years: 0.1 to 3.5 and 1.2 to 3.2; 4 to 8 years: 1.1 to 2.8 and 0.7 to 3.8; 8 to 16 years 0.6 to 3.7 and 1.0 to 3.7, in PEG3350 + E and PEG4000, respectively. Treatment success after 52 weeks was achieved in 50% and 45% of children, respectively (P = 0.69). Rates of adverse events were similar between groups, and no drug-related serious adverse events occurred. CONCLUSIONS: Noninferiority regarding long-term constipation-related symptoms of PEG3350 + E compared to PEG4000 was not demonstrated. However, analysis of secondary outcomes suggests similar efficacy and safety of these agents.

Bladder and bowel dysfunctions in 1748 children referred to pelvic physiotherapy: clinical characteristics and locomotor problems in primary, secondary, and tertiary healthcare settings.

The aims of this study are to evaluate in a pragmatic cross-sectional study, the clinical characteristics of childhood bladder and/or bowel dysfunctions (CBBD) and locomotor problems in the primary through tertiary health care setting. It was hypothesized that problems would increase, going from primary to tertiary healthcare. Data were retrieved from patient-records of children (1-16 years) presenting with CBBD and visiting pelvic physiotherapists. Prevalence's of dysfunctions were compared between healthcare settings and gender using ANOVA and chi-square test. Agreement between physicians' diagnoses and parent-reported symptoms was evaluated (Cohen's Kappa). One thousand seventy hundred forty-eight children (mean age 7.7 years [SD 2.9], 48.9% boys) were included. Daytime urinary incontinence (P = 0.039) and enuresis (P < 0.001) were more diagnosed in primary healthcare, whereas constipation (P < 0.001) and abdominal pain (P = 0.009) increased from primary to tertiary healthcare. All parent-reported symptoms occurred more frequently than indicated by the physicians. Poor agreement between physicians' diagnoses and parent-reported symptoms was found (k = 0.16). Locomotor problems prevailed in all healthcare settings, motor skills (P = 0.041) and core stability (P = 0.015) significantly more in tertiary healthcare. CONCLUSIONS: Constipation and abdominal pain (physicians' diagnoses) and the parent-reported symptoms hard stools and bloating increased from primary to tertiary healthcare. Discrepancies exist between the prevalence's of physicians' diagnoses and parent-reported symptoms. Locomotor problems predominate in all healthcare settings. What is Known: • Childhood bladder and/or bowel dysfunctions (CCBD) are common. • Particularly tertiary healthcare characteristics of CBBD are available What is New: • Characteristics of CBBD referred to pelvic physiotherapy are comparable in primary, secondary, and tertiary healthcare settings. • Concomitant CBBD appeared to be more prevalent than earlier reported. • Discrepancies exist between referring physicians' diagnoses and parent-reported symptoms.

Effectiveness of Pelvic Physiotherapy in Children With Functional Constipation Compared With Standard Medical Care.

BACKGROUND & AIMS: Functional constipation (FC) is a common childhood problem often related to pelvic floor muscle dysfunction. We compared the effectiveness of pelvic physiotherapy (PPT) vs standard medical care (SMC) in children with FC. METHODS: We performed a multicenter randomized controlled trial of 53 children (age, 5-16 y) with FC according to the Rome III criteria, at hospitals in The Netherlands from December 2009 to May 2014. Group allocation was concealed using a central computer system. SMC consisted of education, toilet training, and laxatives (n = 26), whereas PPT included SMC plus specific physiotherapeutic interventions (n = 27). Results were obtained from written reports from the subjects' pediatricians and parents. The primary outcome was absence of FC, according to Rome III criteria, after a 6-month follow-up period. Secondary outcomes were global perceived effect (range, 1-9; success was defined as a score ≥ 8), numeric rating scales assessing quality of life (parent and child; scale, 1-10), and the strengths and difficulties questionnaire (SDQ). RESULTS: Treatment was effective for 92.3% of the children receiving PPT and for 63.0% of the children receiving SMC (adjusted odds ratio for success of PPT, 11.7; 95% confidence interval, 1.8-78.3) (P = .011). Significantly more children undergoing PPT stopped using laxatives (adjusted odds ratio, 6.5; 95% confidence interval, 1.6-26.4) (P = .009). Treatment success (based on global perceived effect) was achieved for 88.5% of subjects receiving PPT vs 33.3% of subjects receiving SMC) (P < .001). PPT also produced larger adjusted mean differences, before vs after treatment, in numeric rating scales to assess quality of life: an increase of 1.8 points for parents (P = .047) and 2.0 points for children (P = .028). Results from the SDQ did not differ significantly between groups (P = .78). CONCLUSIONS: In a randomized controlled trial of children with FC, PPT was more effective than SMC on all outcomes measured, with the exception of findings from the SDQ. PPT should be considered as a treatment option for FC in children 5-16 years old. Dutch Clinical Trial Registration no: NL30551.068.09.

The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

BACKGROUND: Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking. METHODS/DESIGN: A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria. DISCUSSION: This section discusses the relevance of publishing the study design and the development of the presented physiotherapy protocol. It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications. To our knowledge, this article is the first to describe the design of a randomised controlled trial among children with constipation to assess the effect of pelvic physiotherapy as an add-on to standard medical care. TRIAL REGISTRATION: Current Controlled Trials NL30551.068.09.