Prenatal Pelvic Floor Prevention (3PN)

July 25, 2013 updated by: Centre Hospitalier Universitaire de la Réunion

Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial

Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Justification:

Pelvic floor disorders lead to handicap and medical care consumption. Pregnancy and delivery are the main etiologies. Pelvic floor exercises are proposed for prevention and may reduce immediate postpartum incontinence but we do not know if this preventive effect persists at 1 year.

Principal criteria:

  • Urinary incontinence score at 12 months post-partum (ICIQ-SF)

Secondary criteria:

  • Urinary incontinence prevalence at pregnancy end, 2 and 12 months post-partum
  • Other pelvic floor disorders at pregnancy end, 2 and 12 months post-partum: symptoms questionnaires, QOL questionnaire, Pad-test, POP-Q.
  • Mode of delivery, length of active second phase, perineal tears, Apgar score.
  • Number of postpartum pelvic floor session, number of medical consultations, Kegel exercises.

Progress:

  • Inclusion between 20 and 28 weeks, initial assessment, randomization.
  • 8 sessions of pelvic floor exercises with a physiotherapist between 24 and 36 weeks versus written information only.
  • Assessment at pregnancy end, 2 and 12 (+/-1) month post-partum

Study length:

  • For each women 18 months.
  • For each center 30 months.

Number of subjects:

  • To show a 1 point difference on ICIQ-SF score, we need 182 subjects (sd=2,4, a=0,05, β=0,20 bilateral test).
  • Taking in account lost of follow-up (estimated 1/3) we are going to include 280 women.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

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

  • France
      • Clamart, France, 92141
        • CHU Antoine-Béclère
      • Clermont-Ferrand, France, 63058
        • CHU Clermont
      • Nimes, France, 30900
        • CHU Caremeau
      • Saint-Germain, France, 78105
        • CH Poissy-Saint-Germain
    • Réunion
      • Saint-Denis, Réunion, France, 97405
        • CHR Réunion, CH Félix-Guyon

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • nulliparous
  • aged 18 years or more
  • pregnant between 20 and 28 weeks
  • French language reader

Exclusion Criteria:

  • No medical insurance
  • multiple or pathologic pregnancy
  • Previous pelvic floor exercises with a physiotherapist less than 6 months before pregnancy

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rééducation
Standardized pelvic floor muscle training program with a physiotherapist in 8 sessions (20-30 minutes each) between 24 and 36 weeks of gestation AND Written instructions about personal (Kegel) pelvic floor exercises
Other: Pelvic floor muscle training with physiotherapist
8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife
Other Names:
  • pelvic floor exercises
  • Pelvic Floor Muscle Training
  • pelvic floor physiotherapy
Other: Written information about kegel exercises
Information about pelvic floor disorders prevention with personal pelvic floor exercises
Other Names:
  • kegel exercises
Active Comparator: Control
Written instructions about personal (Kegel) pelvic floor exercises
Other: Written information about kegel exercises
Information about pelvic floor disorders prevention with personal pelvic floor exercises
Other Names:
  • kegel exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary incontinence score assessed with ICIQ-SF questionnaire
Time Frame: one year post partum
one year post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary incontinence prevalence
Time Frame: pregnancy end, 2 and 12 months post partum
pregnancy end, 2 and 12 months post partum
Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)
Time Frame: pregnancy end, 2 and 12 months post partum
pregnancy end, 2 and 12 months post partum
Genital prolapse assessed by POP-Q
Time Frame: 2 months post-partum
2 months post-partum
Pelvic floor strength
Time Frame: 2 months post partum
2 months post partum
Quality of life (Euroquol 5D, Contilife)
Time Frame: at delivery, 2 and 12 months post partum
at delivery, 2 and 12 months post partum
pad-test
Time Frame: 2 months post partum
2 months post partum
need to medical care
Time Frame: 12 months post partum
12 months post partum

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
CIC-EC Réunion

Investigators

  • Principal Investigator: Xavier FRITEL, MD, PhD, CHR Réunion, CH Félix Guyon

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

November 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 25, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3PN
  • AFSSAPS-2007-A00641-52

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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