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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578369
First Posted: April 16, 2012
Last Update Posted: April 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mireia Pelaez Puente, Universidad Politecnica de Madrid
  Purpose
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.

Condition Intervention
Pregnancy Urinary Incontinence Other: Exercise classes with pelvic floor muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mireia Pelaez Puente, Universidad Politecnica de Madrid:

Primary Outcome Measures:
  • Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire [ Time Frame: Week 10-14 gestation (baseline), week 36-39 (after intervention) ]

Secondary Outcome Measures:
  • Change from baseline in King's Health Questionnaire [ Time Frame: week 10-14 of gestation (baseline), week 36-39 (after intervention) ]

Enrollment: 169
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise group
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.
Other: Exercise classes with pelvic floor muscle training
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.
No Intervention: Control
Usual care

Detailed Description:
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).
  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578369


Locations
Spain
Universidad Politécnica de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Politecnica de Madrid
Investigators
Study Director: Rubén Barakat, PhD Universidad Politécnica de Madrid
Principal Investigator: Mireia Peláez, PhD Universidad Politécnica de Madrid
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mireia Pelaez Puente, PhD, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier: NCT01578369     History of Changes
Other Study ID Numbers: 240/09B
First Submitted: April 11, 2012
First Posted: April 16, 2012
Last Update Posted: April 16, 2012
Last Verified: April 2012

Keywords provided by Mireia Pelaez Puente, Universidad Politecnica de Madrid:
Urinary incontinence
Pregnancy
Pelvic floor muscle training

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders