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

Primary Purpose

Pregnancy, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise classes with pelvic floor muscle training
Sponsored by
Universidad Politecnica de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Urinary incontinence, Pregnancy, Pelvic floor muscle training

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Politécnica de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire

Secondary Outcome Measures

Change from baseline in King's Health Questionnaire

Full Information

First Posted
April 11, 2012
Last Updated
April 13, 2012
Sponsor
Universidad Politecnica de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01578369
Brief Title
Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Politecnica de Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Urinary Incontinence
Keywords
Urinary incontinence, Pregnancy, Pelvic floor muscle training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Exercise classes with pelvic floor muscle training
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire
Time Frame
Week 10-14 gestation (baseline), week 36-39 (after intervention)
Secondary Outcome Measure Information:
Title
Change from baseline in King's Health Questionnaire
Time Frame
week 10-14 of gestation (baseline), week 36-39 (after intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Barakat, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mireia Peláez, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Politécnica de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32378735
Citation
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
Results Reference
derived
PubMed Identifier
23389863
Citation
Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourol Urodyn. 2014 Jan;33(1):67-71. doi: 10.1002/nau.22381. Epub 2013 Feb 6.
Results Reference
derived

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

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