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Completed

NCT Number: NCT06224335

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

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

Completed

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Key information

Conditions

Stress Urinary Incontinence Athletes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Martin, Slovakia, 03659

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Leakage of urine will be measured by weight of pad in grams.

  2. 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.

    Degree of leakage of urine will be measured by the International Consultation on Incontinence Questionnaire short form in score.

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Collaborators

  • Pavol Jozef Safarik University

Registry information

Official study 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

Acronym: SPORTVAGPRES

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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