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临床试验/NCT07724158
NCT07724158尚未招募不适用

Target Physiotherapy Versus Exercise Support Intervention for Bladder-bowel Dysfunction in Adolescents With Obesity

University of Lisbon1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2027年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
237
试验地点
1
主要终点
Change in bladder-bowel dysfunction symptom severity

研究概览

简要总结

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.

详细描述

Obesity in adolescence is a major public health challenge and is associated with a broad spectrum of metabolic, psychological, and functional complications. While considerable attention has focused on cardiometabolic consequences, bladder-bowel dysfunction (BBD) remains an underrecognized comorbidity in adolescents with obesity. BBD is characterized by the coexistence of lower urinary tract symptoms and bowel dysfunction, particularly functional constipation, in the absence of neurological or anatomical abnormalities. Symptoms may include urinary urgency, daytime urinary incontinence, nocturnal enuresis, infrequent voiding, constipation, and fecal incontinence, all of which can substantially impair health-related quality of life, psychosocial functioning, and participation in school and social activities.

Current evidence suggests that obesity may contribute to the development and persistence of BBD through multiple interacting mechanisms. Increased intra-abdominal pressure may impair pelvic floor and bladder function, while sedentary behavior, inadequate dietary habits, insufficient hydration, and reduced physical activity may contribute to functional constipation and altered bowel habits. Obesity is also associated with chronic low-grade inflammation, sleep disturbances, and psychosocial stress, factors that may further influence bladder and bowel function. Despite growing evidence supporting an association between obesity and BBD, most available studies are observational, and prospective intervention studies targeting both conditions simultaneously are lacking.

Current international recommendations identify standard urotherapy and bowel management as first-line conservative treatment for non-neurogenic bladder-bowel dysfunction in children and adolescents. These interventions aim to modify voiding and bowel habits, optimize hydration, improve toileting posture, reduce dysfunctional elimination behaviors, and restore normal pelvic floor function. Physiotherapy techniques, including pelvic floor muscle training, breathing exercises, lumbo-pelvic mobility exercises, and behavioral education, are increasingly incorporated into multidisciplinary continence management. However, the effectiveness of these approaches has not been specifically evaluated in adolescents with obesity.

Physical exercise may also represent a clinically relevant intervention for BBD. Besides its established role in obesity management, regular physical activity has been associated with lower rates of constipation and may improve several obesity-related mechanisms potentially involved in bladder and bowel dysfunction, including sedentary behavior, sleep quality, systemic inflammation, psychological health, and body composition. Nevertheless, no randomized controlled trials have prospectively evaluated whether structured exercise programs improve bladder-bowel dysfunction in adolescents with obesity.

The OBE-BBD trial was designed to address this important evidence gap. The study is a single-center, parallel-group, three-arm randomized controlled trial conducted at the Pediatric Outpatient Clinic of the Department of Pediatrics, Hospital de Santa Maria, Unidade Local de Saúde de Santa Maria, Lisbon, Portugal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the interventions, participants, intervention providers, and investigators responsible for recruitment and intervention delivery cannot be blinded to treatment allocation. However, participants will not be informed of their baseline bladder-bowel dysfunction (BBD) classification unless clinically necessary. Outcome assessors will remain blinded to group allocation whenever feasible, and participants will be instructed not to disclose their assigned intervention during outcome assessments. Data analyses will be performed using de-identified datasets, and data analysts will remain blinded to treatment allocation until completion of the primary analyses whenever feasible.

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female adolescents aged 13 to 18 years.
  • Obesity defined as BMI z-score ≥2, according to the WHO growth reference for school-aged children and adolescents.
  • Currently receiving obesity treatment at the Pediatric Outpatient Clinic, Department of Pediatrics, Hospital de Santa Maria, Unidade Local de Saúde de Santa Maria, Lisbon, Portugal.
  • Able to understand the study procedures and comply with study requirements.
  • Written informed consent provided by a parent or legal guardian.
  • Written assent provided by the adolescent.

排除标准

  • Known neurological disorder affecting bladder or bowel function.
  • Structural urinary tract or gastrointestinal malformation.
  • Previous pelvic surgery affecting urinary or bowel continence.
  • Diabetes mellitus or uncontrolled endocrine or monogenic disorders affecting obesity or bladder/bowel function.
  • Severe psychiatric disorder requiring immediate specialized treatment and likely to interfere with study participation or adherence.
  • Major orthopedic or musculoskeletal condition preventing safe participation in the exercise intervention.
  • Current participation in another interventional clinical trial.

结局指标

主要结局

Change in bladder-bowel dysfunction symptom severity

时间窗: Baseline and 12 weeks (end of intervention)

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.

次要结局

  • Change in bladder-bowel dysfunction symptom severity at follow-up(12 weeks (end of the intervention) and 3 months after the end of the intervention (follow-up))
  • Change in adolescent bladder-bowel dysfunction symptoms severity(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in health-related quality of life(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in psychological functioning(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in physical activity(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in sedentary behavior(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in sleep quality(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in body mass index (BMI) z-score(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Change in total body fat mass(Baseline, 12 weeks (end of intervention), and 3 months after the end of the intervention (follow-up).)
  • Change in fiber intake(Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up))
  • Intervention-related adverse events(From baseline until completion of follow-up (approximately 24 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Videira-Silva

Professor

University of Lisbon

研究点 (1)

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