Stress Urinary Incontinence in Elite Athletes

• ClinicalTrials.gov Identifier: NCT03938779
• Recruitment Status: Unknown
• First Posted: May 6, 2019
• Last Update Posted: July 8, 2019
• Sponsor: University of Trás-os-Montes and Alto Douro
• Information provided by (Responsible Party): Telma Pires, University of Trás-os-Montes and Alto Douro

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.

Condition or disease	Intervention/treatment	Phase
Pelvic Floor Disorders	Behavioral: Pelvic Floor Muscle Training (PFMT); Diagnostic Test: Pad test	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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: Single (Participant)
• Masking Description: The participants do not know that there is a control group and an intervention group
• Primary Purpose: Treatment
• Official Title: Pelvic Floor Muscle Training and Stress Urinary Incontinence in Elite Athletes . Clinical Trial
• Actual Study Start Date: April 25, 2019
• Actual Primary Completion Date: April 25, 2019
• Estimated Study Completion Date: August 4, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 30 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women have a predisposition to stress urinary incontinence, caused by high-impact exercises
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Elite female athletes
• Nulliparous
• Volleyball team.

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Telma F Pires, MSc; +351 936 972 003; telmafilipapires@gmail.com

Contact: UTAD UTAD; +351 259 350 000

Locations

Portugal

Telma Filipa Rodrigues Pereira Pires; Recruiting

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

Contact: Telma Pires, MSc (+351) 936 972 003 telmafilipapires@gmail.com

Contact: UTAD (+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

Sponsors and Collaborators

University of Trás-os-Montes and Alto Douro

More Information

Publications of Results:

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.

Mørkved S, Bø 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. Review.

Da Roza T, de Araujo MP, Viana R, Viana S, Jorge RN, Bø 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.

• Responsible Party: Telma Pires, principal investigator, University of Trás-os-Montes and Alto Douro
• ClinicalTrials.gov Identifier: NCT03938779
• Other Study ID Numbers: 25/2017
• First Posted: May 6, 2019
• Last Update Posted: July 8, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Telma Pires, University of Trás-os-Montes and Alto Douro:

Elite Athletes; Volleyball; Pelvic Floor Muscle Training

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders; Pregnancy Complications