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Stress Urinary Incontinence in Elite Athletes

Primary Purpose

Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training (PFMT)
Pad test
Sponsored by
University of Trás-os-Montes and Alto Douro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Elite Athletes, Volleyball, Pelvic Floor Muscle Training

Eligibility Criteria

15 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Elite female athletes
  • Nulliparous
  • Volleyball team.

Exclusion Criteria:

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

Sites / Locations

  • Telma Filipa Rodrigues Pereira PiresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Pelvic Floor Muscle Training (PFMT)

Pad test

Kings Health Questionnaire

perineometer

Arm Description

Experimental group will perform for 4 months a PFMT

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)

Kings Health Questionnaire to assess the impact of urinary incontinence on quality of life of women. Both groups will complete the questionnaire.

Both groups will perform perineometry at baseline and 4 months after

Outcomes

Primary Outcome Measures

Pad-test (Short-term)
The pad test is a standardised test for quantifying urine loss.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2019
Last Updated
July 4, 2019
Sponsor
University of Trás-os-Montes and Alto Douro
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1. Study Identification

Unique Protocol Identification Number
NCT03938779
Brief Title
Stress Urinary Incontinence in Elite Athletes
Official Title
Pelvic Floor Muscle Training and Stress Urinary Incontinence in Elite Athletes . Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
August 4, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trás-os-Montes and Alto Douro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Elite Athletes, Volleyball, Pelvic Floor Muscle Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Volleyball team will be evaluated in two moments, at the beginning and 4 months after the PFMT. After 4 months, to compare with the control group and to evaluate if there are differences between groups, namely muscle strength
Masking
Participant
Masking Description
The participants do not know that there is a control group and an intervention group
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Floor Muscle Training (PFMT)
Arm Type
Experimental
Arm Description
Experimental group will perform for 4 months a PFMT
Arm Title
Pad test
Arm Type
Experimental
Arm Description
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)
Arm Title
Kings Health Questionnaire
Arm Type
No Intervention
Arm Description
Kings Health Questionnaire to assess the impact of urinary incontinence on quality of life of women. Both groups will complete the questionnaire.
Arm Title
perineometer
Arm Type
No Intervention
Arm Description
Both groups will perform perineometry at baseline and 4 months after
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Muscle Training (PFMT)
Intervention Description
PFMT is a protocol of exercises for prevention and treatment for Stress Urinary Incontinence in elite females athletes, volleyball team
Intervention Type
Diagnostic Test
Intervention Name(s)
Pad test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pad-test (Short-term)
Description
The pad test is a standardised test for quantifying urine loss.
Time Frame
2 hour 30 min
Other Pre-specified Outcome Measures:
Title
Kings Health Questionnaire (KHQ)
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women have a predisposition to stress urinary incontinence, caused by high-impact exercises
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elite female athletes Nulliparous Volleyball team. Exclusion Criteria: Inability to contract the PFM, elderly Prolapse of the pelvic organs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Telma F Pires, MSc
Phone
+351 936 972 003
Email
telmafilipapires@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
UTAD UTAD
Phone
+351 259 350 000
Facility Information:
Facility Name
Telma Filipa Rodrigues Pereira Pires
City
Vila Real
State/Province
Trás-os-Montes E Alto Douro
ZIP/Postal Code
5000-438
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Telma Pires, MSc
Phone
(+351) 936 972 003
Email
telmafilipapires@gmail.com
First Name & Middle Initial & Last Name & Degree
UTAD
Phone
(+351) 259 350 000
First Name & Middle Initial & Last Name & Degree
Patrícia Pires, MSc
First Name & Middle Initial & Last Name & Degree
Helena Moreira, Dr
First Name & Middle Initial & Last Name & Degree
Paulo Vicente, Dr
First Name & Middle Initial & Last Name & Degree
Sara Viana, Dr
First Name & Middle Initial & Last Name & Degree
Rui Viana, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
28977091
Citation
Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
Results Reference
result
PubMed Identifier
23365417
Citation
Morkved S, Bo K. Effect of pelvic floor muscle training during pregnancy and after childbirth on prevention and treatment of urinary incontinence: a systematic review. Br J Sports Med. 2014 Feb;48(4):299-310. doi: 10.1136/bjsports-2012-091758. Epub 2013 Jan 30.
Results Reference
result
PubMed Identifier
22552685
Citation
Da Roza T, de Araujo MP, Viana R, Viana S, Jorge RN, Bo K, Mascarenhas T. Pelvic floor muscle training to improve urinary incontinence in young, nulliparous sport students: a pilot study. Int Urogynecol J. 2012 Aug;23(8):1069-73. doi: 10.1007/s00192-012-1759-2. Epub 2012 May 3.
Results Reference
result

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Stress Urinary Incontinence in Elite Athletes

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