Urinary Incontinence, StressINCREASENCT03309397
Stress Urinary Incontinence of Sporting Teenager
An observational study of Urinary Incontinence, Stress, run by University Hospital, Brest at 1 site in France.
Trial summary
Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular practice. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2018to 16 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Sporting Young Girl
Who may be able to join
- Between 10 and 18 years
- Consultation in medical sporting center
Who cannot join
- urge incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Urinary Incontinence in Teenage Girls Practicing Sports
Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular practice. However, depending on the discipline and level of practice, it may be responsible for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders or cardiovascular events. It also promotes urinary stress incontinence, by increasing intra-abdominal pressure in some situations.
The prevalence of urinary leakage in the athlete depends of the practiced physical activity. A classification of the sports activities can be carried out according to the risk of increased pressures on the pelvic floor:
Read more
- high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial arts;
- moderate-risk sports: tennis, skiing ...
- low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary incontinence also depends of the practiced movements (jumps, abdominal exercises ...), and the occurence of sports activity. This disorder has even become one of the concerns of federal sports authority (INSEP).
However, there is no data regarding stress incontinence of sports teenagers found n the literature on
- Conditions
- Urinary Incontinence, Stress
- Keywords
- adolescent sports
- Medical subject headings
- Urinary Incontinence, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of stress urinary incontinence in adolescent girls engaged in extra-scholar sports
answer by YES or NO to the question
Measured: Day 0
Secondary outcomes (1)
Delay of urinary incontinence according to the first menstruations
answer to question about the delay of first menstruations on day: less than 6 months- between 6 and 12 months- more than 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start17 Jan 2018
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309397
- Sponsor's protocol ID
- INCREASE ( 29BRC17.0114)
- Acronym
- INCREASE
- Status last verified
- Aug 2019
- First submitted
- 6 Oct 2017
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Urinary Incontinence in Teenage Girls Practicing Sports
- ClinicalTrials.gov ID
- NCT03309397
- Acronym / sponsor ID
- INCREASE / INCREASE ( 29BRC17.0114)
- Conditions
- Urinary Incontinence, Stress
- Keywords
- adolescent sports
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular practice. However, depending on the discipline and level of practice, it may be responsible for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders or cardiovascular events. It also promotes urinary stress incontinence, by increasing intra-abdominal pressure in some situations.
The prevalence of urinary leakage in the athlete depends of the practiced physical activity. A classification of the sports activities can be carried out according to the risk of increased pressures on the pelvic floor:
- high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial arts;
- moderate-risk sports: tennis, skiing ...
- low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary incontinence also depends of the practiced movements (jumps, abdominal exercises ...), and the occurence of sports activity. This disorder has even become one of the concerns of federal sports authority (INSEP).
However, there is no data regarding stress incontinence of sports teenagers found n the literature on
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Sporting Young Girl
Key inclusion criteria (2 listed)
- Between 10 and 18 years
- Consultation in medical sporting center
Key exclusion criteria (1 listed)
- urge incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of stress urinary incontinence in adolescent girls engaged in extra-scholar sports
Time frame: Day 0
answer by YES or NO to the question
1 secondary outcome
Delay of urinary incontinence according to the first menstruations
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Stress, run by University Hospital, Brest at 1 site in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Aug 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of stress urinary incontinence in adolescent girls engaged in extra-scholar sports (time frame: Day 0). 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 12 Aug 2019.