Stress Urinary IncontinenceSPORTVAGPRESNCT06224335
Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
An observational study of Stress Urinary Incontinence and Athletes, run by Comenius University at 1 site in Slovakia.
Trial summary
To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Athletes
- What is being tested?
- intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running
- How many people
- 10 participants
- Where
- 1 siteSlovakia
- Study dates
- 28 Sep 2023to 28 Mar 2024
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: sportwoman with high intensity of physical activity with and without stress urinary incontinence
Who may be able to join
- nulliparous women
- aged 18-35
- high-intensity physical activity
- performed sport at least three days per week, 90 minutes per day, for more than two years
Who cannot join
- handicapped sportswomen
- performance of various kinds of sport
- no regular sport activity
- performance of sports for less than two years
- after childbirth
- surgical treatment of gynaecological and urological illnesses
Show all 12Show fewer
- urinary tract infection
- disease of respiratory tract
- not sufficiently completed questionnaires
- refusal to participate
- body mass index greater than 30 (BMI = m/h2, where m = body weight in kilograms and h = body height in metres)
- symptoms of overactive bladder
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic
Martin, Slovakia, 03659
About this study
Official title: Femfit® and an Innovative Pad Test to Assess Pelvic Floor Muscle Activation During Physical Activity in Sportwoman with and Without SUI - a Pilot Study
To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.
Read the detailed description
This is an observational comparative pilot study in which we will compare intravaginal and intra-abdominal pressure and an innovative pad test in 5 female athletes with stress urinary incontinence and 5 without incontinence.
- Conditions
- Stress Urinary Incontinence, Athletes
- Being tested
- intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running
- Keywords
- Stress urinary incontinence, Athletes, Intravaginal pressure, Intra-abdominal pressure
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast runningDiagnostic test
Also called intravaginal and intra-abdominal pressure with Femfit® device during (squeeeze, knack, rapid contractions, endurance contracions), inovative pad test during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running
Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.
| Study group | Role | What they receive |
|---|---|---|
| sportwoman with high intensity of physical activity with stress urinary incontinence | High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years. Receives: Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running | |
| sportwoman with high intensity of physical activity without stress urinary incontinence | High-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years. Receives: Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.
Intravaginal and intra-abdominal pressure will be measured in mmHg.
Measured: During the performance of sporting activities up to 60 minutes.
Secondary outcomes (2)
To detect the amount of urine leakage by an innovative pad test in sportwoman.
Leakage of urine will be measured by weight of pad in grams.
Measured: During the performance of sporting activities up to 60 minutes.
To detect the degree of urinary leakage by the International Consultation on Incontinence Questionnaire in sportwoman.
Degree of leakage of urine will be measured by the International Consultation on Incontinence Questionnaire short form in score.
Measured: During the performance of sporting activities up to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start28 Sep 2023
- Primary completion14 Feb 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- Pavol Jozef Safarik University
- Responsible party
- Sponsor
- Investigators
- Magdaléna Hagovská, Dr., PhD, Study director, Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224335
- Sponsor's protocol ID
- EC UNM 115/2023
- Acronym
- SPORTVAGPRES
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request
Publications
Kruger JA, Dietz HP, Murphy BA. Pelvic floor function in elite nulliparous athletes. Ultrasound Obstet Gynecol. 2007 Jul;30(1):81-5. doi: 10.1002/uog.4027.
PubMed 17497753Hagovska M, Bukova A, Svihra J. Measurement of the Vaginal Pressure Profile with the Femfit(R) and Leakage Events Using a Newly Developed Pad Test during Selected Sports Activities: A Pilot Study. Int Urogynecol J. 2025 Apr;36(4):789-797. doi: 10.1007/s00192-025-06051-y. Epub 2025 Jan 21.
PubMed 39836175
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femfit® and an Innovative Pad Test to Assess Pelvic Floor Muscle Activation During Physical Activity in Sportwoman with and Without SUI - a Pilot Study
- ClinicalTrials.gov ID
- NCT06224335
- Acronym / sponsor ID
- SPORTVAGPRES / EC UNM 115/2023
- Conditions
- Stress Urinary Incontinence, Athletes
- Keywords
- Stress urinary incontinence, Athletes, Intravaginal pressure, Intra-abdominal pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- Pavol Jozef Safarik University
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 25 Jan 2024 (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.
To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.
Detailed description
This is an observational comparative pilot study in which we will compare intravaginal and intra-abdominal pressure and an innovative pad test in 5 female athletes with stress urinary incontinence and 5 without incontinence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sportwoman with high intensity of physical activity with stress urinary incontinence | – | Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast runningHigh-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years. |
| sportwoman with high intensity of physical activity without stress urinary incontinence | – | Diagnostic Test: intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast runningHigh-intensity of regular physical activity at least three days per week, 90 minutes per day, for more than two years. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- sportwoman with high intensity of physical activity with and without stress urinary incontinence
Key inclusion criteria (4 listed)
- nulliparous women
- aged 18-35
- high-intensity physical activity
- performed sport at least three days per week, 90 minutes per day, for more than two years
Key exclusion criteria (12 listed)
- handicapped sportswomen
- performance of various kinds of sport
- no regular sport activity
- performance of sports for less than two years
- after childbirth
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 |
|---|---|---|
| intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast runningAlso: intravaginal and intra-abdominal pressure with Femfit® device during (squeeeze, knack, rapid contractions, endurance contracions), inovative pad test during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast runningChange in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities. | Diagnostic test | sportwoman with high intensity of physical activity with stress urinary incontinence, sportwoman with high intensity of physical activity without stress urinary incontinence |
Primary outcome
To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.
Time frame: During the performance of sporting activities up to 60 minutes.
Intravaginal and intra-abdominal pressure will be measured in mmHg.
2 secondary outcomes
To detect the amount of urine leakage by an innovative pad test in sportwoman.
Time frame: During the performance of sporting activities up to 60 minutes.
To detect the degree of urinary leakage by the International Consultation on Incontinence Questionnaire in sportwoman.
Time frame: During the performance of sporting activities up to 60 minutes.
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 5 Sep 2024.
- Background: PubMed 17497753Kruger JA, Dietz HP, Murphy BA. Pelvic floor function in elite nulliparous athletes. Ultrasound Obstet Gynecol. 2007 Jul;30(1):81-5. doi: 10.1002/uog.4027.
- Derived from this study: PubMed 39836175Hagovska M, Bukova A, Svihra J. Measurement of the Vaginal Pressure Profile with the Femfit(R) and Leakage Events Using a Newly Developed Pad Test during Selected Sports Activities: A Pilot Study. Int Urogynecol J. 2025 Apr;36(4):789-797. doi: 10.1007/s00192-025-06051-y. Epub 2025 Jan 21.
- Individual participant dataSharing planned: No. On request
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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.
Magdaléna Hagovská, Dr., PhD study director
Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
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 Stress Urinary Incontinence and Athletes, run by Comenius University at 1 site in Slovakia.
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 4 inclusion and 12 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 5 Sep 2024. 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 Slovakia. 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?
To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence. (time frame: During the performance of sporting activities up to 60 minutes.). 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 NCT06224335, which also lists 2 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 5 Sep 2024.