Pelvic Floor DisordersNCT03938779
Stress Urinary Incontinence in Elite Athletes
A study testing Pelvic Floor Muscle Training (PFMT) and Pad test in people with Pelvic Floor Disorders, run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
Trial summary
A protocol of pelvic floor muscles training (PFMT) in elite athletes was applied. They will do it for 4 months. Then re-evaluated. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Pelvic Floor Muscle Training (PFMT) and Pad test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Apr 2019to 4 Aug 2019
- Phase
- Interventional
- 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Elite female athletes
- Nulliparous
- Volleyball team.
Who cannot join
- Inability to contract the PFM, elderly
- Prolapse of the pelvic organs.
Trial locations and contacts
1 site in 1 country.
UTAD UTAD contact
Portugal1 site, 1 recruiting
- Recruiting
Telma Filipa Rodrigues Pereira Pires
Vila Real, Trás-os-Montes E Alto Douro, 5000-438
Telma Pires, MSc, (+351) 936 972 003, telmafilipapires@gmail.com
UTAD, (+351) 259 350 000
About this study
Official title: Pelvic Floor Muscle Training and Stress Urinary Incontinence in Elite Athletes . Clinical Trial
A protocol of pelvic floor muscles training (PFMT) in elite athletes was applied. They will do it for 4 months. Then re-evaluated.
Read the detailed description
The athletes of the Portuguese national female's volleyball team were evaluated through perineometry, pad-test and Kings health questionnaire. They were taught a plan of pelvic floor muscles training (PFMT) to perform for 4 months. After this time they will be re-evaluated with the same measuring instruments.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Pelvic Floor Muscle Training (PFMT), Pad test
- Keywords
- Elite Athletes, Volleyball, Pelvic Floor Muscle Training
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training (PFMT)Behavioural
PFMT is a protocol of exercises for prevention and treatment for Stress Urinary Incontinence in elite females athletes, volleyball team
Pad testDiagnostic test
Pad test is a standardised test for quantifying urine loss. Pad test is not invasive and provide an easy, inexpensive and objective assessment of urine loss.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Experimental | Experimental group will perform for 4 months a PFMT Receives: Behavioral: Pelvic Floor Muscle Training (PFMT) |
| Pad test | Experimental | The experimental and control group will perform the pad test twice. At the beginning of the evaluation and 4 months after the PFMT. The modified pad test, has the durability of a workout (2h30min) Receives: Diagnostic Test: Pad test |
| Kings Health Questionnaire | No intervention | Kings Health Questionnaire to assess the impact of urinary incontinence on quality of life of women. Both groups will complete the questionnaire. |
| perineometer | No intervention | Both groups will perform perineometry at baseline and 4 months after |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pad-test (Short-term)
The pad test is a standardised test for quantifying urine loss.
Measured: 2 hour 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start25 Apr 2019
- Primary completion25 Apr 2019
- Study completion4 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Volleyball team will be evaluated in two moments, at the beginning and 4 months after the PFMT. After 4 months, to compare with the control group and to evaluate if there are differences between groups, namely muscle strength
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Telma Pires, University of Trás-os-Montes and Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938779
- Sponsor's protocol ID
- 25/2017
- Status last verified
- Jul 2019
- First submitted
- 25 Apr 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Urinary incontinence is a public health problem, which we must combat intervention measures and publication of clinical trials to prevent and treat urinary incontinence. The PFMT is the first line treatment advised by recent literature.
Publications
Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
PubMed 28977091Morkved S, Bo K. Effect of pelvic floor muscle training during pregnancy and after childbirth on prevention and treatment of urinary incontinence: a systematic review. Br J Sports Med. 2014 Feb;48(4):299-310. doi: 10.1136/bjsports-2012-091758. Epub 2013 Jan 30.
PubMed 23365417Da Roza T, de Araujo MP, Viana R, Viana S, Jorge RN, Bo K, Mascarenhas T. Pelvic floor muscle training to improve urinary incontinence in young, nulliparous sport students: a pilot study. Int Urogynecol J. 2012 Aug;23(8):1069-73. doi: 10.1007/s00192-012-1759-2. Epub 2012 May 3.
PubMed 22552685
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Training and Stress Urinary Incontinence in Elite Athletes . Clinical Trial
- ClinicalTrials.gov ID
- NCT03938779
- Acronym / sponsor ID
- 25/2017
- Conditions
- Pelvic Floor Disorders
- Keywords
- Elite Athletes, Volleyball, Pelvic Floor Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 4 Aug 2019 (estimated)
- First posted
- 6 May 2019 (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.
A protocol of pelvic floor muscles training (PFMT) in elite athletes was applied. They will do it for 4 months. Then re-evaluated.
Detailed description
The athletes of the Portuguese national female's volleyball team were evaluated through perineometry, pad-test and Kings health questionnaire. They were taught a plan of pelvic floor muscles training (PFMT) to perform for 4 months. After this time they will be re-evaluated with the same measuring instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Volleyball team will be evaluated in two moments, at the beginning and 4 months after the PFMT. After 4 months, to compare with the control group and to evaluate if there are differences between groups, namely muscle strength
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Experimental | Behavioral: Pelvic Floor Muscle Training (PFMT)Experimental group will perform for 4 months a PFMT |
| Pad test | Experimental | Diagnostic Test: Pad testThe experimental and control group will perform the pad test twice. At the beginning of the evaluation and 4 months after the PFMT. The modified pad test, has the durability of a workout (2h30min) |
| Kings Health Questionnaire | No intervention | –Kings Health Questionnaire to assess the impact of urinary incontinence on quality of life of women. Both groups will complete the questionnaire. |
| perineometer | No intervention | –Both groups will perform perineometry at baseline and 4 months after |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Elite female athletes
- Nulliparous
- Volleyball team.
Key exclusion criteria (2 listed)
- Inability to contract the PFM, elderly
- Prolapse of the pelvic organs.
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 |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT)PFMT is a protocol of exercises for prevention and treatment for Stress Urinary Incontinence in elite females athletes, volleyball team | Behavioural | Pelvic Floor Muscle Training (PFMT) |
| Pad testPad test is a standardised test for quantifying urine loss. Pad test is not invasive and provide an easy, inexpensive and objective assessment of urine loss. | Diagnostic test | Pad test |
Primary outcome
Pad-test (Short-term)
Time frame: 2 hour 30 min
The pad test is a standardised test for quantifying urine loss.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Results publication: PubMed 28977091Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
- Results publication: PubMed 23365417Morkved S, Bo K. Effect of pelvic floor muscle training during pregnancy and after childbirth on prevention and treatment of urinary incontinence: a systematic review. Br J Sports Med. 2014 Feb;48(4):299-310. doi: 10.1136/bjsports-2012-091758. Epub 2013 Jan 30.
- Results publication: PubMed 22552685Da Roza T, de Araujo MP, Viana R, Viana S, Jorge RN, Bo K, Mascarenhas T. Pelvic floor muscle training to improve urinary incontinence in young, nulliparous sport students: a pilot study. Int Urogynecol J. 2012 Aug;23(8):1069-73. doi: 10.1007/s00192-012-1759-2. Epub 2012 May 3.
- Individual participant dataSharing planned: No. Urinary incontinence is a public health problem, which we must combat intervention measures and publication of clinical trials to prevent and treat urinary incontinence. The PFMT is the first line treatment advised by recent literature.
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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.
UTAD UTAD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training (PFMT) and Pad test in people with Pelvic Floor Disorders, run by University of Trás-os-Montes and Alto Douro 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 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Telma F Pires, MSc (+351 936 972 003, telmafilipapires@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pad-test (Short-term) (time frame: 2 hour 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938779, which also lists 3 linked publications.
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 8 Jul 2019.