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

NCT07724158 | Not Yet Recruiting

• 1 other identifier: OBE-BBD
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder-Bowel Dysfunction; Obesity & Overweight

Keywords

Adolescent obesity; Bladder-bowel dysfunction; Lower urinary tract symptoms; Functional constipation; Urotherapy; Pelvic floor physiotherapy; Bowel management; Physical exercise; High-intensity interval training; Conservative treatment; Non-pharmacological intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks (end of intervention)

Secondary Outcomes (11)

• 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)

Study Arms (3)

Target physiotherapy plus usual care

EXPERIMENTAL

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

Exercise support intervention plus usual care

EXPERIMENTAL

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

Usual obesity care

ACTIVE COMPARATOR

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

Interventions

Exercise support intervention BEHAVIORAL

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

Exercise support intervention plus usual care

Usual obesity care OTHER

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.

Exercise support intervention plus usual care; Target physiotherapy plus usual care; Usual obesity care

Target physiotherapy BEHAVIORAL

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

Target physiotherapy plus usual care

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lisbon: lead
• NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa: collaborator
• CIDEFES - Universidade Lusofona: collaborator

Study Sites (1)

Hospital de Santa Maria, ULS SM

Lisbon, Portugal

Location

MeSH Terms

Conditions

Obesity; Overweight; Pediatric Obesity; Lower Urinary Tract Symptoms; Motor Activity

Interventions

Exercise Therapy; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urological Manifestations; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Antonio Videira-Silva, PhD

CONTACT

+351 969172368; antonioascenso@campus.ul.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single-center, three-arm, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. Following baseline assessment, eligible participants will be randomly assigned to one of two active intervention groups (target physiotherapy integrated with urotherapy and bowel management, or an exercise support intervention) or to a usual care control group. Randomization will be stratified by sex and baseline bladder-bowel dysfunction status using a computer-generated sequence with randomly varying block sizes. The intervention period will last 12 weeks, with outcome assessments conducted at baseline, immediately after the intervention (12 weeks), and 3 months after intervention completion. Due to the nature of the interventions, participants and intervention providers cannot be blinded; however, outcome assessors and data analysts will be blinded whenever feasible.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

PT (1)