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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03938779
Other study ID # 25/2017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2019
Est. completion date August 4, 2019

Study information

Verified date July 2019
Source University of Trás-os-Montes and Alto Douro
Contact Telma F Pires, MSc
Phone +351 936 972 003
Email telmafilipapires@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date August 4, 2019
Est. primary completion date April 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 30 Years
Eligibility Inclusion Criteria:

- Elite female athletes

- Nulliparous

- Volleyball team.

Exclusion Criteria:

- Inability to contract the PFM, elderly

- Prolapse of the pelvic organs.

Study Design


Intervention

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
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.

Locations

Country Name City State
Portugal Telma Filipa Rodrigues Pereira Pires Vila Real Trás-os-Montes E Alto Douro

Sponsors (1)

Lead Sponsor Collaborator
University of Trás-os-Montes and Alto Douro

Country where clinical trial is conducted

Portugal, 

References & Publications (3)

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/s00192-012-1 — View Citation

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 J — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Kings Health Questionnaire (KHQ) 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
Primary Pad-test (Short-term) The pad test is a standardised test for quantifying urine loss. 2 hour 30 min
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