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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578369
• Other study ID #: 240/09B
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: April 13, 2012
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: April 2012
• Source: Universidad Politecnica de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Politécnica de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire		Week 10-14 gestation (baseline), week 36-39 (after intervention)	No
Secondary	Change from baseline in King's Health Questionnaire		week 10-14 of gestation (baseline), week 36-39 (after intervention)	No