Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)

NCT ID: NCT06224335

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-03-28

Brief Summary

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To compare the impact of selected physical activities on pelvic floor and stress urinary incontinence in sportwoman.

Detailed Description

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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

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Stress Urinary Incontinence Athletes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

Intervention Type DIAGNOSTIC_TEST

Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.

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.

intra-abdominal pressure with Femfit® device during (jumps on the ground, jumps on a trampoline, weightlifting, slow running, fast running

Intervention Type DIAGNOSTIC_TEST

Change in intravaginal and intra-abdominal pressure assessed by Femfit® , leakage of urine in grams assessed by inovative pad test during 5 sports activities.

Interventions

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intra-abdominal pressure with Femfit® device 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pavol Jozef Safarik University

OTHER

Sponsor Role collaborator

Comenius University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magdaléna Hagovská, Dr., PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic

Locations

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Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic

Martin, Slovakia, Slovakia

Site Status

Countries

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Slovakia

References

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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.

Reference Type BACKGROUND
PMID: 17497753 (View on PubMed)

Hagovska 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.

Reference Type DERIVED
PMID: 39836175 (View on PubMed)

Other Identifiers

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EC UNM 115/2023

Identifier Type: -

Identifier Source: org_study_id

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