Prenatal Pelvic Floor Prevention (3PN)

Urinary Incontinence Clinical Trial

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

Status Completed

Clinical 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.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence
• Genital Prolapse
• Urinary Incontinence

• NCT number: NCT00551551
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de la Réunion
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Completion date: September 2011