- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07710508
Difference in Incontinence Prevalence Between High Impact Athletes, Low Impact Athletes and Sedentary Subjects.
Difference in Incontinence Prevalence Between High Impact Athletes, Low Impact Athletes and Sedentary Subjects. A Functional Analysis.
This observational cross-sectional study aims to investigate the association between participation in high-impact sports, physical activity level, and urinary incontinence in young adults. The study will compare six groups based on sex and physical activity level: male and female high-impact sports participants, physically active males and females who do not participate in high-impact sports, and sedentary males and females.
Participants aged 18-35 years will undergo a single assessment including sociodemographic and medical information, physical activity assessment, urinary incontinence questionnaires, sport-related characteristics, psychosocial questions regarding the influence of social taboos on questionnaire responses, lower-limb muscle strength testing using a load cell, and vertical jump performance assessment.
The study aims to describe the prevalence, severity, type, and impact of urinary incontinence across different activity levels and sexes, and to explore potential associations with lower-limb strength, jump performance, and sport-related characteristics.
Study Overview
Status
Intervention / Treatment
Detailed Description
Urinary incontinence is a common condition that may affect both women and men and has been associated with physical activity and participation in high-impact sports. Although regular exercise provides substantial health benefits, repetitive increases in intra-abdominal pressure during high-impact activities may contribute to pelvic floor dysfunction in susceptible individuals. Most previous studies have focused on female athletes from specific sports, while evidence including both sexes and different physical activity levels remains limited.
This observational cross-sectional study will compare urinary incontinence characteristics among six population groups defined according to sex and physical activity level: male and female participants in high-impact sports, physically active males and females who do not participate in high-impact sports, and sedentary males and females.
Participants will attend a single face-to-face assessment session after providing written informed consent. During the visit, sociodemographic and clinical information, physical activity characteristics, sport-related variables, urinary incontinence questionnaires, and psychosocial questions related to social taboos and response honesty will be collected. Lower-limb muscle strength will be assessed using a load cell system, and jump performance will be evaluated using the My Jump 2 application.
The primary objective is to compare the prevalence, severity, type, and impact of urinary incontinence across the different study groups. Secondary analyses will explore the relationship between urinary incontinence and physical activity level, lower-limb muscle strength, jump performance, sport-related characteristics, and selected demographic and clinical variables.
Participants will be recruited through social media, institutional dissemination, and sports clubs using voluntary convenience and snowball sampling. All assessments will be performed by trained researchers following standardized procedures.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Valencia
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Valencia, Valencia, Spain, 46010
- Gascó Oliag, 5
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 to 35 years.
- Male or female participants.
- Able to understand and provide written informed consent.
- Belong to one of the following groups:
Regular participation in high-impact sports (≥2 training sessions per week for at least the previous 2 years).
Physically active individuals meeting the World Health Organization recommendations (≥150 minutes/week of moderate-intensity activity, ≥75 minutes/week of vigorous-intensity activity, or an equivalent combination), without regular participation in high-impact sports.
Sedentary individuals who do not meet the World Health Organization physical activity recommendations.
Exclusion Criteria:
- Pregnancy or childbirth within the previous 12 months.
- Current or recent urinary tract infection.
- History of urogynecological disease or pelvic/urogynecological surgery.
- Body mass index (BMI) >35 kg/m².
- Inability to understand or complete the study procedures or questionnaires in Spanish or English.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Male High-Impact Sports Participants
Males aged 18-35 years who regularly participate in high-impact sports (at least twice per week for the previous two years).
|
No intervention
|
|
Female High-Impact Sports Participants
Females aged 18-35 years who regularly participate in high-impact sports (at least twice per week for the previous two years).
|
No intervention
|
|
Physically Active Males
Males aged 18-35 years who meet the World Health Organization physical activity recommendations but do not participate in high-impact sports.
|
No intervention
|
|
Physically Active Females
Females aged 18-35 years who meet the World Health Organization physical activity recommendations but do not participate in high-impact sports.
|
No intervention
|
|
Sedentary Males
Males aged 18-35 years who do not meet the World Health Organization physical activity recommendations.
|
No intervention
|
|
Sedentary Females
Females aged 18-35 years who do not meet the World Health Organization physical activity recommendations.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary incontinence severity
Time Frame: Baseline (single study visit)
|
Urinary incontinence severity assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Higher scores indicate greater symptom severity and impact on quality of life.
The total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence symptoms and greater impact on quality of life.
|
Baseline (single study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary incontinence-related quality of life
Time Frame: Baseline (single study visit)
|
Quality of life associated with urinary incontinence assessed using the Incontinence Quality of Life Questionnaire (I-QOL).
The total score ranges from 0 to 100, with higher scores indicating better urinary incontinence-related quality of life.
|
Baseline (single study visit)
|
|
Lower-limb muscle strength
Time Frame: Baseline (single study visit)
|
Maximum voluntary force and mean voluntary force of hip adduction, abduction, flexion, extension, internal rotation, and external rotation measured using a load cell and ChronoJump software.
|
Baseline (single study visit)
|
|
Vertical jump performance
Time Frame: Baseline (single study visit)
|
Vertical jump performance assessed using the My Jump 2 application.
|
Baseline (single study visit)
|
|
Physical activity level
Time Frame: Baseline (single study visit)
|
Physical activity level assessed using the International Physical Activity Questionnaire (IPAQ).
Physical activity is expressed as metabolic equivalent (MET)-minutes per week and classified into low, moderate, or high physical activity levels, according to the IPAQ scoring protocol.
Higher MET-minutes per week indicate greater levels of physical activity.
|
Baseline (single study visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Urinary Incontinence
- Urinary Incontinence, Stress
- Motor Activity
Other Study ID Numbers
- Sports_UI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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