NCT00551551

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

3.8 years

First QC Date

October 30, 2007

Last Update Submit

July 25, 2013

Conditions

Urinary IncontinenceAnal IncontinenceGenital Prolapse

Keywords

Pelvic floorKegel exercisesQuality of LifePelvic Pain

Outcome Measures

Primary Outcomes (1)

  • Urinary incontinence score assessed with ICIQ-SF questionnaire

    one year post partum

Secondary Outcomes (7)

  • Urinary incontinence prevalence

    pregnancy end, 2 and 12 months post partum

  • Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)

    pregnancy end, 2 and 12 months post partum

  • Genital prolapse assessed by POP-Q

    2 months post-partum

  • Pelvic floor strength

    2 months post partum

  • Quality of life (Euroquol 5D, Contilife)

    at delivery, 2 and 12 months post partum

  • +2 more secondary outcomes

Study Arms (2)

Rééducation

EXPERIMENTAL

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 physiotherapistOther: Written information about kegel exercises

Control

ACTIVE COMPARATOR

Written instructions about personal (Kegel) pelvic floor exercises

Other: Written information about kegel exercises

Interventions

Pelvic floor muscle training with physiotherapistOTHER

8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife

Also known as: pelvic floor exercises, Pelvic Floor Muscle Training, pelvic floor physiotherapy
Rééducation
Written information about kegel exercisesOTHER

Information about pelvic floor disorders prevention with personal pelvic floor exercises

Also known as: kegel exercises
ControlRééducation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHR Réunion, CH Félix-Guyon

Saint-Denis, Réunion, 97405, France

Location

CHU Antoine-Béclère

Clamart, 92141, France

Location

CHU Clermont

Clermont-Ferrand, 63058, France

Location

CHU Caremeau

Nîmes, 30900, France

Location

CH Poissy-Saint-Germain

Saint-Germain, 78105, France

Location

Related Publications (2)

  • 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.

    PMID: 32378735DERIVED

  • Fritel X, de Tayrac R, Bader G, Savary D, Gueye A, Deffieux X, Fernandez H, Richet C, Guilhot J, Fauconnier A. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):370-377. doi: 10.1097/AOG.0000000000000972.

    PMID: 26241428DERIVED

MeSH Terms

Conditions

Urinary IncontinenceEncopresisPelvic Pain

Interventions

Physical Therapists

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination DisordersMental DisordersPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Xavier FRITEL, MD, PhD

    CHR Réunion, CH Félix Guyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 26, 2013

Record last verified: 2013-07

Locations

FR(5)