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Bladder-Bowel DysfunctionOBE-BBDNCT07724158

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

A study testing Target physiotherapy, Exercise support intervention and Usual obesity care in people with Bladder-Bowel Dysfunction and Obesity & Overweight, run by University of Lisbon at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 years
What is being tested?
Target physiotherapy, Exercise support intervention and Usual obesity care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
1 sitePortugal
Study dates
4 Jan 2027to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio Videira-Silva, PhD contact

+351 969172368

antonioascenso@campus.ul.pt

Portugal1 site
  • Hospital de Santa Maria, ULS SM

    Lisbon

    Antonio Videira-Silva, PhD, +351 969172368, antonioascenso@campus.ul.pt

Other trials in Portugal

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
Target physiotherapy, Exercise support intervention, Usual obesity care
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
Medical subject headings
Obesity, Overweight, Pediatric Obesity, Lower Urinary Tract Symptoms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Target physiotherapyBehavioural

    Also called Integrated urotherapy, Pelvic floor physiotherapy, Bladder-bowel rehabilitation, Bowel management

    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 interventionBehavioural

    Also called Exercise therapy, High-intensity interval training (HIIT), Home-based HIIT, Supervised exercise

    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 careOther

    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.

Study groups in NCT07724158
Study groupRoleWhat they receive
Target physiotherapy plus usual careExperimentalParticipants 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.
Receives: Behavioral: Target physiotherapy; Other: Usual obesity care
Exercise support intervention plus usual careExperimentalParticipants 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.
Receives: Behavioral: Exercise support intervention; Other: Usual obesity care
Usual obesity careActive comparatorParticipants 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.
Receives: Other: Usual obesity care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 12 weeks (end of intervention)

Secondary outcomes (11)
  1. 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.

    Measured: 12 weeks (end of the intervention) and 3 months after the end of the intervention (follow-up)

  2. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  3. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  4. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  5. 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).

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  6. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  7. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  8. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  9. 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).

    Measured: Baseline, 12 weeks (end of intervention), and 3 months after the end of the intervention (follow-up).

  10. 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.

    Measured: Baseline, 12 weeks (end of the intervention), and 3 months after the end of the intervention (follow-up)

  11. Intervention-related adverse events

    Occurrence of adverse events recorded throughout the study.

    Measured: From baseline until completion of follow-up (approximately 24 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start4 Jan 2027 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
237 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07724158
Sponsor's protocol ID
OBE-BBD
Acronym
OBE-BBD
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
23 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified IPD will possibly be available upon reasonable request after publication, subject to ethics approval and institutional policies.

Questions about this trial

What is this clinical trial studying?

A study testing Target physiotherapy, Exercise support intervention and Usual obesity care in people with Bladder-Bowel Dysfunction and Obesity & Overweight, run by University of Lisbon at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antonio Videira-Silva, PhD (+351 969172368, antonioascenso@campus.ul.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in bladder-bowel dysfunction symptom severity (time frame: Baseline and 12 weeks (end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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