An interventional study of Target physiotherapy and Exercise support intervention in Bladder-Bowel Dysfunction and Obesity & Overweight, sponsored by University of Lisbon. Not yet recruiting at 1 site in Portugal. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Lisbon · Not applicable, Interventional, and Treatment
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.
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.
Adolescents aged 13 to 18 years receiving multidisciplinary treatment for obesity will be invited to participate. After baseline assessment, eligible participants will be randomly allocated in a 1:1:1 ratio to one of three study groups: (1) target physiotherapy integrated with urotherapy and bowel management in addition to usual obesity care; (2) an exercise support intervention in addition to usual obesity care; or (3) usual obesity care alone.
Both active interventions will be delivered over a 12-week period between routine obesity clinic visits.
The target physiotherapy program combines standardized urotherapy education, bowel-management strategies, pelvic floor muscle training, diaphragmatic breathing, lumbo-pelvic mobility exercises, stretching, strengthening exercises, and a structured home-based exercise program.
The exercise support intervention is designed to reinforce adherence to physical activity recommendations routinely prescribed during obesity treatment through supervised exercise sessions and a standardized home-based high-intensity interval training (HIIT) program specifically adapted for adolescents with obesity. The exercise intervention intentionally excludes any educational or behavioral content specifically addressing bladder or bowel dysfunction in order to isolate the effects of exercise itself.
Participants allocated to the control group will continue to receive the standard multidisciplinary obesity management routinely provided at the clinic, including pediatric, nutritional, and exercise counseling. To avoid contamination between study arms, participants in the exercise intervention and usual care groups will not receive targeted bladder-bowel dysfunction education or treatment during the intervention period unless clinically required for safety.
Participants requiring urgent management due to clinically significant deterioration will receive appropriate medical care according to standard clinical practice.
The primary objective of the trial is to determine whether either target physiotherapy or the exercise support intervention reduces bladder-bowel dysfunction symptom severity compared with usual obesity care. Secondary objectives include evaluating the effects of the interventions on urinary symptoms, functional constipation, urinary incontinence, enuresis, urinary tract infections, health-related quality of life, psychological functioning, physical activity, sedentary behavior, sleep, dietary habits, body composition, and obesity-related outcomes. The study will also investigate whether improvements in lifestyle behaviors or obesity-related characteristics mediate changes in bladder-bowel dysfunction symptoms.
Participants will undergo evaluations at baseline, immediately after completion of the 12-week intervention, and three months after the end of the intervention to examine both short-term and sustained effects.
Outcome assessment includes validated patient-reported questionnaires, clinical evaluation, objective anthropometric measurements, accelerometry, dietary assessment, and routinely collected clinical information.
The study is expected to provide the first randomized evidence comparing targeted physiotherapy and structured exercise support as non-pharmacological strategies for improving bladder-bowel dysfunction in adolescents with obesity. The findings may contribute to the development of integrated multidisciplinary treatment approaches that address both obesity and functional bladder-bowel disorders, with the potential to improve physical health, psychological well-being, and quality of life in this vulnerable population.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 237 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Lisbon is the lead sponsor of 40 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the clinic's standard multidisciplinary obesity care together with a 12-week target physiotherapy program integrating standard urotherapy, bowel-management education, pelvic floor muscle training, diaphragmatic breathing, lumbo-pelvic mobility exercises, stretching and strengthening exercises, supervised physiotherapy sessions, and a structured home exercise program.
Behavioral: Target physiotherapy · Other: Usual obesity care
Participants will receive the clinic's standard multidisciplinary obesity care together with a 12-week exercise support intervention consisting of supervised exercise sessions and a standardized home-based high-intensity interval training (HIIT) program designed for adolescents with obesity. The intervention reinforces adherence to physical activity recommendations but does not include bladder-bowel dysfunction education or urotherapy.
Behavioral: Exercise support intervention · Other: Usual obesity care
Participants will receive the standard multidisciplinary obesity management routinely provided at the Pediatric Outpatient Clinic, including follow-up with a pediatrician, nutritionist, and exercise physiologist, with counseling on healthy eating and physical activity according to routine clinical practice.
Other: Usual obesity care
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.
Also known as: Integrated urotherapy, Pelvic floor physiotherapy, Bladder-bowel rehabilitation, Bowel management, Conservative bladder-bowel management, Non-pharmacological bladder-bowel 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.
Also known as: Exercise therapy, High-intensity interval training (HIIT), Home-based HIIT, Supervised exercise
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.
Change in bladder-bowel dysfunction symptom severity
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.
Time frame: Baseline and 12 weeks (end of intervention)
Change in bladder-bowel dysfunction symptom severity at follow-up
Change in bladder-bowel dysfunction symptom severity from baseline to the 3-month follow-up after completion of the intervention, assessed using the Vancouver Symptom Score (VSS) for Dysfunctional Elimination Syndrome. The VSS is a validated 14-item questionnaire with a total score ranging from 0 to 52, where higher scores indicate greater bladder-bowel dysfunction symptom severity. A reduction in the total score indicates improvement in symptoms. A validated version of the instrument for Portuguese will be used.
Time frame: 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
Change in bladder and bowel symptoms assessed using the Childhood Bladder and Bowel Dysfunction Questionnaire 12-18 (CBBDQ-12-18). Total score ranges from 0 to 72, with higher scores indicating greater symptom severity. A validated version of the instrument for Portuguese will be used.
Time frame: 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
Change in health-related quality of life from baseline to 12 weeks and 3-month follow-up, assessed using the Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a validated 23-item questionnaire that generates scores ranging from 0 to 100, with higher scores indicating better health-related quality of life. An increase in the total score indicates improvement in health-related quality of life. A validated version of the instrument for Portuguese will be used.
Time frame: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)
Change in psychological functioning
Change in psychological functioning from baseline to 12 weeks and 3-month follow-up, assessed using the Strengths and Difficulties Questionnaire (SDQ). The SDQ is a validated 25-item questionnaire. The Total Difficulties Score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral difficulties (worse psychological functioning). A decrease in the Total Difficulties Score indicates improvement in psychological functioning. A validated version of the instrument for Portuguese will be used.
Time frame: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)
Change in physical activity
Change in physical activity from baseline to 12 weeks and 3-month follow-up, assessed objectively using the ActiGraph GT3X accelerometer and confirmed by a structured clinical interview. Physical activity will be quantified as the average daily time spent in stationary and light, moderate, and vigorous physical activity (minutes/day).
Time frame: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)
Change in sedentary behavior
CChange in sedentary behavior assessed using accelerometer-derived stationary time and the Adolescent Sedentary Activity Questionnaire (ASAQ). The ASAQ is a self-reported questionnaire that assesses the time adolescents spend in a broad range of sedentary activities outside school hours. It includes sedentary activities across five domains: screen-based recreation, educational activities, sedentary transportation, cultural activities, and social activities. Participants report the duration of each activity separately for weekdays and weekend days. Responses are used to calculate sedentary time, expressed in minutes per day, for each domain and for total sedentary behavior. A validated version of the instrument for Portuguese will be used.
Time frame: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)
Change in sleep quality
Change in sleep quality from baseline to 12 weeks and 3-month follow-up, assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated 19-item questionnaire that generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A decrease in the global PSQI score indicates improvement in sleep quality. A validated version of the instrument for Portuguese will be used.
Time frame: 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
Change in body mass index (BMI) z-score from baseline to 12 weeks and 3-month follow-up. BMI will be calculated from objectively measured weight (kg) and height (m) using standard procedures, and BMI z-scores will be calculated according to the World Health Organization (WHO) growth reference for school-aged children and adolescents using WHO AnthroPlus software.
Time frame: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)
Change in total body fat mass
Change in total body fat mass (kg) from baseline to 12 weeks and 3-month follow-up, assessed by bioelectrical impedance analysis (InBody 580, Seoul, Republic of Korea).
Time frame: Baseline, 12 weeks (end of intervention), and 3 months after the end of the intervention (follow-up).
Change in fiber intake
Change in dietary fiber intake (g/day) from baseline to 12 weeks and 3-month follow-up, assessed using 3-day food records (2 weekdays and 1 weekend day). Dietary intake will be analyzed independently by at least two trained nutritionists to estimate average daily fiber intake.
Time frame: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)
Intervention-related adverse events
Occurrence of adverse events recorded throughout the study.
Time frame: From baseline until completion of follow-up (approximately 24 weeks)
Plan to share: Undecided — De-identified IPD will possibly be available upon reasonable request after publication, subject to ethics approval and institutional policies.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 11 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Lisbon