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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mireia Pelaez Puente, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier:
NCT01578369
First received: April 11, 2012
Last updated: April 13, 2012
Last verified: April 2012
  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: 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 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in King's Health Questionnaire [ Time Frame: week 10-14 of gestation (baseline), week 36-39 (after intervention) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Universidad Politecnica de Madrid

Additional 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
Study First Received: April 11, 2012
Last Updated: April 13, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Politecnica de Madrid:
Urinary incontinence
Pregnancy
Pelvic floor muscle training

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

ClinicalTrials.gov processed this record on August 28, 2014