Prenatal Pelvic Floor Prevention (3PN)

Phase 3

Completed

• Conditions: Urinary Incontinence; Anal Incontinence; Genital Prolapse
• Interventions: Other: Pelvic floor muscle training with physiotherapist; Other: Written information about kegel exercises

• Registration Number: NCT00551551
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

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 Timeline

• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Study First Posted: 2007-10-31
• Study Start: 2007-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-25
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rééducation	Pelvic floor muscle training with physiotherapist	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
Rééducation	Written information about kegel exercises	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
Control	Written information about kegel exercises	Written instructions about personal (Kegel) pelvic floor exercises

Primary Outcome Measures

Name	Time	Method
Urinary incontinence score assessed with ICIQ-SF questionnaire	one year post partum

Secondary Outcome Measures

Name	Time	Method
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
pad-test	2 months post partum
need to medical care	12 months post partum

Trial Locations

Locations (5)

CHR Réunion, CH Félix-Guyon; 🇫🇷 Saint-Denis, Réunion, France

CHU Antoine-Béclère; 🇫🇷 Clamart, France

CHU Clermont; 🇫🇷 Clermont-Ferrand, France

CH Poissy-Saint-Germain; 🇫🇷 Saint-Germain, France

CHU Caremeau; 🇫🇷 Nimes, France