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Urinary IncontinencePhase 3NCT00551551

Prenatal Pelvic Floor Prevention (3PN)

A Phase 3 study testing Pelvic floor muscle training with physiotherapist and Written information about kegel exercises in people with Urinary Incontinence and Anal Incontinence, run by Centre Hospitalier Universitaire de la Réunion at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pelvic floor muscle training with physiotherapist and Written information about kegel exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
5 sitesFrance
Study dates
Nov 2007to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • CHU Antoine-Béclère

    Clamart, 92141

  • CHU Clermont

    Clermont-Ferrand, 63058

  • CHU Caremeau

    Nîmes, 30900

  • CHR Réunion, CH Félix-Guyon

    Saint-Denis, Réunion, 97405

  • CH Poissy-Saint-Germain

    Saint-Germain, 78105

Other trials in France

About this study

Official title: 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.

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.
Being tested
Pelvic floor muscle training with physiotherapist, Written information about kegel exercises
Keywords
Pelvic floor, Kegel exercises, Quality of Life, Pelvic Pain
Medical subject headings
Urinary Incontinence, Encopresis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic floor muscle training with physiotherapistOther

    Also called pelvic floor exercises, Pelvic Floor Muscle Training, pelvic floor physiotherapy

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

  • Written information about kegel exercisesOther

    Also called kegel exercises

    Information about pelvic floor disorders prevention with personal pelvic floor exercises

Study groups in NCT00551551
Study groupRoleWhat they receive
RééducationExperimentalStandardized 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
Receives: Other: Pelvic floor muscle training with physiotherapist; Other: Written information about kegel exercises
ControlActive comparatorWritten instructions about personal (Kegel) pelvic floor exercises
Receives: Other: Written information about kegel exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary incontinence score assessed with ICIQ-SF questionnaire

    Measured: one year post partum

Secondary outcomes (7)

  1. Urinary incontinence prevalence

    Measured: pregnancy end, 2 and 12 months post partum

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

    Measured: pregnancy end, 2 and 12 months post partum

  3. Genital prolapse assessed by POP-Q

    Measured: 2 months post-partum

  4. Pelvic floor strength

    Measured: 2 months post partum

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

    Measured: at delivery, 2 and 12 months post partum

  6. pad-test

    Measured: 2 months post partum

  7. need to medical care

    Measured: 12 months post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00551551
Sponsor's protocol ID
3PN
Other IDs
AFSSAPS-2007-A00641-52
Status last verified
Jul 2013
First submitted
30 Oct 2007
Last updated
26 Jul 2013
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pelvic floor muscle training with physiotherapist and Written information about kegel exercises in people with Urinary Incontinence and Anal Incontinence, run by Centre Hospitalier Universitaire de la Réunion at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary incontinence score assessed with ICIQ-SF questionnaire (time frame: one year post partum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00551551, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.

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