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CompletedNCT00551551Updated Jul 26, 2013

Prenatal Pelvic Floor Prevention (3PN)

A Phase 3 interventional study of Pelvic floor muscle training with physiotherapist and Written information about kegel exercises in Urinary Incontinence, Anal Incontinence and Genital Prolapse, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 5 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-26.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Urinary Incontinence
  • Anal Incontinence
  • Genital Prolapse

Keywords

  • Pelvic floor
  • Kegel exercises
  • Quality of Life
  • Pelvic Pain
03

In context

Urinary Incontinence

1,375 studies on the registry are indexed under Urinary Incontinence; 224 are open to participants now.

This study's enrollment of 280 is above the median of 66 across 1,021 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 140 studies on the registry; 36 are open to participants now.

Browse Centre Hospitalier Universitaire de la Réunion studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No medical insurance
  • multiple or pathologic pregnancy
  • Previous pelvic floor exercises with a physiotherapist less than 6 months before pregnancy
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
280 participants (actual)

Study arms

  • 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 · Other: Written information about kegel exercises

  • Active comparator
    Control

    Written instructions about personal (Kegel) pelvic floor exercises

    Other: Written information about kegel exercises

Interventions

  • OtherPelvic floor muscle training with physiotherapist

    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

  • OtherWritten information about kegel exercises

    Information about pelvic floor disorders prevention with personal pelvic floor exercises

    Also known as: kegel exercises

06

What researchers measure

Primary outcomes

  1. Urinary incontinence score assessed with ICIQ-SF questionnaire

    Time frame: one year post partum

Secondary outcomes

  1. Urinary incontinence prevalence

    Time frame: pregnancy end, 2 and 12 months post partum

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

    Time frame: pregnancy end, 2 and 12 months post partum

  3. Genital prolapse assessed by POP-Q

    Time frame: 2 months post-partum

  4. Pelvic floor strength

    Time frame: 2 months post partum

  5. Quality of life (Euroquol 5D, Contilife)

    Time frame: at delivery, 2 and 12 months post partum

  6. pad-test

    Time frame: 2 months post partum

  7. need to medical care

    Time frame: 12 months post partum

07

Study locations

5 sites
  • CHR Réunion, CH Félix-Guyon
    Saint-Denis, Réunion 97405, France
  • CHU Antoine-Béclère
    Clamart, 92141, France
  • CHU Clermont
    Clermont-Ferrand, 63058, France
  • CHU Caremeau
    Nîmes, 30900, France
  • CH Poissy-Saint-Germain
    Saint-Germain, 78105, France
08

References and documents

Publications

  • 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. PubMed 32378735 ↗
  • 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. PubMed 26241428 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2007
First posted
Oct 31, 2007
Start
Nov 2007
Primary completionActual
Sep 2011
CompletionActual
Sep 2011
Last update
Jul 26, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00551551
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
CIC-EC Réunion, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Oct 31, 2007
Start date
Nov 2007
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 26, 2013

Study contacts

Xavier FRITEL, MD, PhD
principal investigator · CHR Réunion, CH Félix Guyon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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