Clinical trial NCT06224335: Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Athletes
Keywords: Stress urinary incontinence
Athletes
Intravaginal pressure
Intra-abdominal pressure
Lead sponsor: Comenius University
Sponsor class: OTHER
Collaborators: name: Pavol Jozef Safarik University
First posted: 2024-01-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: sportwoman with high intensity of physical activity with and without stress urinary incontinence

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.
timeFrame: During the performance of sporting activities up to 60 minutes.
Secondary outcomes:
measure: To detect the amount of urine leakage by an innovative pad test in sportwoman.
timeFrame: During the performance of sporting activities up to 60 minutes.
measure: To detect the degree of urinary leakage by the International Consultation on Incontinence Questionnaire in sportwoman.
timeFrame: During the performance of sporting activities up to 60 minutes.
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: Department of Urology, Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic
Study officials:
affiliation: Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic
name: Magdaléna Hagovská, Dr., PhD
role: STUDY_DIRECTOR
References:
citation: 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.