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

April 13, 2012 updated by: Mireia Pelaez Puente, Universidad Politecnica de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Politecnica de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Politecnica de Madrid

Investigators

  • Principal Investigator: Mireia Peláez, PhD, Universidad Politécnica de Madrid.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (Estimate)

April 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 16, 2012

Last Update Submitted That Met QC Criteria

April 13, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240/09B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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