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Clinical Trials/NCT06224335
NCT06224335
Active, not recruiting
Not Applicable

Femfit® and an Innovative Pad Test to Assess Pelvic Floor Muscle Activation During Physical Activity in Sportwoman With and Without SUI - a Pilot Study

Comenius University1 site in 1 country10 target enrollmentSeptember 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Comenius University
Enrollment
10
Locations
1
Primary Endpoint
To measure intravaginal and intra-abdominal pressure with Femfit® device in sportwoman with and wihout Stress Urinary Incontinence.
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2023
End Date
March 28, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Comenius University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

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

  • To detect the degree of urinary leakage by the International Consultation on Incontinence Questionnaire in sportwoman.(During the performance of sporting activities up to 60 minutes.)
  • To detect the amount of urine leakage by an innovative pad test in sportwoman.(During the performance of sporting activities up to 60 minutes.)

Study Sites (1)

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