Clinical trial
Target Physiotherapy Versus Exercise Support Intervention for Bladder-bowel Dysfunction in Adolescents With Obesity
Opening soon · Not applicable · 1 countries · Registry ID NCT07724158
What this study is about
Bladder and bowel dysfunction (BBD) is a common condition that includes problems such as urinary urgency, daytime urinary incontinence, bedwetting, constipation, or difficulties emptying the bladder or bowel. These symptoms can negatively affect quality of life, emotional well-being, school participation, and social relationships. Adolescents with obesity may be at a higher risk of developing BBD, but few studies have evaluated effective treatments specifically for this population. The OBE-BBD trial is a randomized controlled study designed to evaluate whether two different non-drug interventions can improve bladder and bowel symptoms in adolescents with obesity when added to standard obesity care. Adolescents aged 13 to 18 years receiving treatment for obesity at the Pediatric Outpatient Clinic of Hospital de Santa Maria (Lisbon, Portugal) will be randomly assigned to one of three groups: (i)Target physiotherapy, consisting of individualized urotherapy and bowel-management education combined with pelvic floor muscle training, breathing exercises, lumbopelvic mobility exercises, stretching, strengthening exercises, and a structured home exercise program; (ii) Exercise support intervention, consisting of supervised physical exercise sessions and a standardized home-based high-intensity interval training (HIIT) program designed for adolescents with obesity; or (iii) Usual care, consisting of the standard multidisciplinary obesity treatment provided at the clinic. Both intervention programs will last 12 weeks. Participants will be assessed before the intervention, immediately after the 12-week intervention period, and again 3 months later. The main objective is to determine whether either intervention reduces the severity of bladder and bowel dysfunction symptoms compared with usual care. The study will also examine whether the interventions improve urinary symptoms, constipation, urinary tract infections, quality of life, psychological well-being, physical activity, sedentary behavior, sleep, dietary habits, and obesity-related outcomes. In addition, the study will investigate whether changes in lifestyle behaviors and obesity-related measures help explain improvements in bladder and bowel symptoms. The results of this study are expected to provide new evidence on effective, non-pharmacological treatment strategies for adolescents with obesity and bladder-bowel dysfunction and may support more comprehensive, multidisciplinary care for this population.
Basic eligibility
Full registry criteria
Treatments and study arms
Target physiotherapy
Participants will receive a 12-week physiotherapy program integrating urotherapy and bowel management. The intervention includes one individual 60-minute session followed by five group sessions delivered every two weeks. The program provides education on bladder and bowel habits, hydration, toileting posture, pelvic floor muscle relaxation and training, diaphragmatic breathing, lumbo-pelvic mobility exercises, stretching, strengthening exercises, and individualized progression according to clinical needs. Participants will also complete a structured home-based exercise program (25-30 minutes, three times per week) and receive telephone support between face-to-face sessions to reinforce adherence.
Exercise support intervention
Participants will receive a 12-week supervised exercise support program consisting of one initial 60-minute supervised session followed by five 30-minute follow-up sessions every two weeks. The intervention supports adherence to routine physical activity recommendations through supervised practice, exercise progression, and correction of movement technique. Participants will perform a standardized home-based high-intensity interval training (HIIT) program lasting approximately 25-30 minutes, three times per week. The intervention does not include urotherapy or bladder-bowel management education.
Usual obesity care
Participants will continue the standard multidisciplinary obesity treatment routinely delivered at the Pediatric Outpatient Clinic. Standard care includes regular follow-up appointments with a pediatrician, nutritionist, and exercise physiologist approximately every three months, including medical evaluation, nutritional counseling, and individualized physical activity counseling according to routine clinical practice. No targeted bladder-bowel dysfunction treatment will be provided during the intervention period unless clinically indicated.
Primary outcomes
Change in bladder-bowel dysfunction (BBD) symptom severity from baseline to 12 weeks, assessed using the Vancouver Symptom Score (VSS). The VSS is a validated 14-item questionnaire with total scores ranging from 0 to 52, where higher scores indicate greater symptom severity. The primary analysis will compare changes in VSS scores between the two intervention groups and the usual care group. A validated version of the instrument for Portuguese will be used.
Study locations
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