Stress Urinary Incontinence in Elite Athletes

July 4, 2019 updated by: Telma Pires, University of Trás-os-Montes and Alto Douro

Pelvic Floor Muscle Training and Stress Urinary Incontinence in Elite Athletes . Clinical Trial

A protocol of pelvic floor muscles training (PFMT) in elite athletes was applied. They will do it for 4 months. Then re-evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The athletes of the Portuguese national female's volleyball team were evaluated through perineometry, pad-test and Kings health questionnaire. They were taught a plan of pelvic floor muscles training (PFMT) to perform for 4 months. After this time they will be re-evaluated with the same measuring instruments.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Trás-os-Montes E Alto Douro
      • Vila Real, Trás-os-Montes E Alto Douro, Portugal, 5000-438
        • Recruiting
        • Telma Filipa Rodrigues Pereira Pires
        • Contact:
        • Contact:
          • UTAD
          • Phone Number: (+351) 259 350 000
        • Sub-Investigator:
          • Patrícia Pires, MSc
        • Sub-Investigator:
          • Helena Moreira, Dr
        • Sub-Investigator:
          • Paulo Vicente, Dr
        • Sub-Investigator:
          • Sara Viana, Dr
        • Sub-Investigator:
          • Rui Viana, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Elite female athletes
  • Nulliparous
  • Volleyball team.

Exclusion Criteria:

  • Inability to contract the PFM, elderly
  • Prolapse of the pelvic organs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic Floor Muscle Training (PFMT)
Experimental group will perform for 4 months a PFMT
Behavioral: Pelvic Floor Muscle Training (PFMT)
PFMT is a protocol of exercises for prevention and treatment for Stress Urinary Incontinence in elite females athletes, volleyball team
Experimental: Pad test
The experimental and control group will perform the pad test twice. At the beginning of the evaluation and 4 months after the PFMT. The modified pad test, has the durability of a workout (2h30min)
Diagnostic test: Pad test
Pad test is a standardised test for quantifying urine loss. Pad test is not invasive and provide an easy, inexpensive and objective assessment of urine loss.
No Intervention: Kings Health Questionnaire
Kings Health Questionnaire to assess the impact of urinary incontinence on quality of life of women. Both groups will complete the questionnaire.
No Intervention: perineometer
Both groups will perform perineometry at baseline and 4 months after

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pad-test (Short-term)
Time Frame: 2 hour 30 min
The pad test is a standardised test for quantifying urine loss.
2 hour 30 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kings Health Questionnaire (KHQ)
Time Frame: 10 minutes
Was constructed in order to assess the impact of urinary incontinence on quality of life women, also evaluating urinary symptoms and subjective measures of severity. The KHQ is composed of 21 items investigating nine domains and it evaluates the agreement of the subjects on a 4- and 5- option Likert scale: general health perceptions (1item), incontinence impact (1 item), role limitations (2 items), physical limitations (2 items), social limitations (2 items), personal relationships (3 items), emotions (3 items), sleep and energy (2 items) and severity measures (5 items). Additionally, it has an independent subscale designed as a Symptom Severity Scale, which contains 11 items, measuring the presence and severity of urinary symptoms (Appendix 5). The KHQ scored from a minimum of 0 (best QoL) to a maximum of 100 (worst QoL), scored by every domain and by their global score. Scores of independent subscale (Symptom Severity Scale) was calculated in the same way.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trás-os-Montes and Alto Douro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2019

Primary Completion (Actual)

April 25, 2019

Study Completion (Anticipated)

August 4, 2019

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Urinary incontinence is a public health problem, which we must combat intervention measures and publication of clinical trials to prevent and treat urinary incontinence. The PFMT is the first line treatment advised by recent literature.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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