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Completed

NCT Number: NCT01578369

Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy

To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.

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Key information

Conditions

Pregnancy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Politécnica de Madrid

Madrid, 28040, Spain

About this study

Pregnancy and childbirth are known risk factors for development of female urinary incontinence (UI). Studies have found that Pelvic Floor Mucle Trainig (PFMT) is effective in preventing and reducing UI during pregnancy and after childbirth. However, in a recent study, no effect was found when PFMT were taught in a general fitness class without former palpation of the pelvic floor muscles (Bo y Haakstad, 2011).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous with singleton baby
  • Not suffering from urinary incontinence
  • Giving birth at Hospital Universitario de Fuenlabrada
  • Able to comunicate in Spanish
  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines

Exclusion criteria

  • Multiparity
  • At risk of Premature birth
  • Following another exercise program

Treatment and study plan

Exercise classes with pelvic floor muscle training

Other

Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.

Primary outcomes

  1. Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire

    Time frame: Week 10-14 gestation (baseline), week 36-39 (after intervention)

Secondary outcomes

  1. Change from baseline in King's Health Questionnaire

    Time frame: week 10-14 of gestation (baseline), week 36-39 (after intervention)

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Registry information

Official study title

Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2012
Registry last updated
Apr 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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