Urinary IncontinenceNCT07639580
Urinary Incontinence and Low Energy Avaliability in Professional and Pre-professional Dancers: a Cross-sectional Study
An observational study of Urinary Incontinence and RED-S, run by University of Siena at 1 site in Italy.
Trial summary
The purpose of this study is to describe the prevalence of Urinary Incontinence amongst professional and pre-professional dancers and its relation to Low Energy Avaliability Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, RED-S
- What is being tested?
- ICIQ-UI-SF (International Consultation on Incontinence Questionnarie - Urinary Incontinence Short Form)
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy professional and pre-professional dancers aged 18+
Who may be able to join
- Professional dancers (must have danced professionally, with a work contract in the last 6 months) OR pre-professional student (currently enrolled in a high-level dance academy or pre-professional course)
Who cannot join
- Current or previous pregnancy
- Low level of Italian or English language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Urinary Incontinence and Low Energy Avaliability in Professional and Pre-professional Female Dancers: a Cross-sectional Study
The purpose of this study is to describe the prevalence of Urinary Incontinence amongst professional and pre-professional dancers and its relation to Low Energy Avaliability
Read the detailed description
Urinary incontinence is a widespread issue among the female athletic population, negatively impacting both performance and lifestyle. The discipline of dance subjects the pelvic floor to repeated stress, which, as in other sports, could lead to the development of incontinence and other pelvic symptoms. Relative Energy Deficiency in Sport (RED-S) syndrome is caused by a prolonged and problematic energy deficit, or Low Energy Availability (LEA), and could be one of the contributing factors to the development of urinary incontinence (UI). The world of professional dance is characterized by a high risk of RED-S; nonetheless, few studies have investigated the prevalence of urinary incontinence and its relationship with low energy availability in this context.
This study aims at investigating the prevalence of urinary incontinence and the risk of relative Low Energy Availability (LEA) in a population of professional and pre-professional female dancers, and secondarily, to study the correlation between these two parameters and their impact on the participants' quality of life and performance.
Data Collection: Administration of validated Italian questionnaires for self-reported urinary incontinence (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form or ICIQ-UI SF) and for the risk of Low Energy Availability (Low Energy Availability in Females Questionnaire or LEAF-Q) via Google Forms. All data will be collected anonymously.
Statistical Analisys: Based on the data distribution (normal or non-normal), the most appropriate descriptive statistics will be used, along with Student's t-test or the Mann-Whitney test, calculating the 95% confidence interval for all variables under study (pages 4-5 of the research project).
All analyses will be conducted using SPSS (version 26 or later) and, for specific verifications, JASP (version 0.96.0).
- Conditions
- Urinary Incontinence, RED-S
- Being tested
- ICIQ-UI-SF (International Consultation on Incontinence Questionnarie - Urinary Incontinence Short Form)
- Keywords
- Urinary Incontinece, Low Energy Avaliability, Dancers, RED-S
- Medical subject headings
- Urinary Incontinence, Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICIQ-UI-SF (International Consultation on Incontinence Questionnarie - Urinary Incontinence Short Form)Other
Also called LEAF-Q (Low Energy Avaliability in Females Questionnaire)
Participants will be administered 2 patient-reported outcome questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence
Prevalence of Urinary Incontinence
Measured: 12 months
Secondary outcomes (1)
Low Energy Avaliability
Low energy avaliability risk is defined by a score <8 at the LEAF-Q
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 posted10 Jun 2026
- Study start1 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabetta Bigi, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639580
- Sponsor's protocol ID
- LEA_UI_Dancers
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence and Low Energy Avaliability in Professional and Pre-professional Female Dancers: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07639580
- Acronym / sponsor ID
- LEA_UI_Dancers
- Conditions
- Urinary Incontinence, RED-S
- Keywords
- Urinary Incontinece, Low Energy Avaliability, Dancers, RED-S
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jun 2026 (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.
The purpose of this study is to describe the prevalence of Urinary Incontinence amongst professional and pre-professional dancers and its relation to Low Energy Avaliability
Detailed description
Urinary incontinence is a widespread issue among the female athletic population, negatively impacting both performance and lifestyle. The discipline of dance subjects the pelvic floor to repeated stress, which, as in other sports, could lead to the development of incontinence and other pelvic symptoms. Relative Energy Deficiency in Sport (RED-S) syndrome is caused by a prolonged and problematic energy deficit, or Low Energy Availability (LEA), and could be one of the contributing factors to the development of urinary incontinence (UI). The world of professional dance is characterized by a high risk of RED-S; nonetheless, few studies have investigated the prevalence of urinary incontinence and its relationship with low energy availability in this context.
This study aims at investigating the prevalence of urinary incontinence and the risk of relative Low Energy Availability (LEA) in a population of professional and pre-professional female dancers, and secondarily, to study the correlation between these two parameters and their impact on the participants' quality of life and performance.
Data Collection: Administration of validated Italian questionnaires for self-reported urinary incontinence (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form or ICIQ-UI SF) and for the risk of Low Energy Availability (Low Energy Availability in Females Questionnaire or LEAF-Q) via Google Forms. All data will be collected anonymously.
Statistical Analisys: Based on the data distribution (normal or non-normal), the most appropriate descriptive statistics will be used, along with Student's t-test or the Mann-Whitney test, calculating the 95% confidence interval for all variables under study (pages 4-5 of the research project).
All analyses will be conducted using SPSS (version 26 or later) and, for specific verifications, JASP (version 0.96.0).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy professional and pre-professional dancers aged 18+
Key inclusion criteria (1 listed)
- Professional dancers (must have danced professionally, with a work contract in the last 6 months) OR pre-professional student (currently enrolled in a high-level dance academy or pre-professional course)
Key exclusion criteria (2 listed)
- Current or previous pregnancy
- Low level of Italian or English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICIQ-UI-SF (International Consultation on Incontinence Questionnarie - Urinary Incontinence Short Form)Also: LEAF-Q (Low Energy Avaliability in Females Questionnaire)Participants will be administered 2 patient-reported outcome questionnaires | Other | – |
Primary outcome
Urinary Incontinence
Time frame: 12 months
Prevalence of Urinary Incontinence
1 secondary outcome
Low Energy Avaliability
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 and RED-S, run by University of Siena at 1 site in Italy.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 10 Jun 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 Italy. 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?
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?
Urinary Incontinence (time frame: 12 months). 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 10 Jun 2026.