NCT03938779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

April 25, 2019

Last Update Submit

July 4, 2019

Conditions

Pelvic Floor Disorders

Keywords

Elite AthletesVolleyballPelvic Floor Muscle Training

Outcome Measures

Primary Outcomes (1)

  • Pad-test (Short-term)

    The pad test is a standardised test for quantifying urine loss.

    2 hour 30 min

Other Outcomes (1)

  • Kings Health Questionnaire (KHQ)

    10 minutes

Study Arms (4)

Pelvic Floor Muscle Training (PFMT)

EXPERIMENTAL

Experimental group will perform for 4 months a PFMT

Behavioral: Pelvic Floor Muscle Training (PFMT)

Pad test

EXPERIMENTAL

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

Kings Health Questionnaire

NO INTERVENTION

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

perineometer

NO INTERVENTION

Both groups will perform perineometry at baseline and 4 months after

Interventions

Pelvic Floor Muscle Training (PFMT)BEHAVIORAL

PFMT is a protocol of exercises for prevention and treatment for Stress Urinary Incontinence in elite females athletes, volleyball team

Pelvic Floor Muscle Training (PFMT)
Pad testDIAGNOSTIC_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.

Pad test

Eligibility Criteria

Age15 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen have a predisposition to stress urinary incontinence, caused by high-impact exercises
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Elite female athletes
  • Nulliparous
  • Volleyball team.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Telma Filipa Rodrigues Pereira Pires

Vila Real, Trás-os-Montes E Alto Douro, 5000-438, Portugal

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28977091RESULT

  • 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.

    PMID: 23365417RESULT

  • 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.

    PMID: 22552685RESULT

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Central Study Contacts

Telma F Pires, MSc

CONTACT

+351 936 972 003telmafilipapires@gmail.com

UTAD UTAD

CONTACT

+351 259 350 000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants do not know that there is a control group and an intervention group
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 6, 2019

Study Start

April 25, 2019

Primary Completion

April 25, 2019

Study Completion

August 4, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

PT(1)