Prenatal Pelvic Floor Prevention (3PN)

Centre Hospitalier Universitaire de la Réunion

Status and phase: Completed; Phase 3

Conditions: Anal Incontinence; Genital Prolapse; Urinary Incontinence

Treatments: Other: Pelvic floor muscle training with physiotherapist; Other: Written information about kegel exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT00551551

3PN

AFSSAPS-2007-A00641-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Rééducation

Experimental group

Description:

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

Treatment:

Other: Written information about kegel exercises

Other: Pelvic floor muscle training with physiotherapist

Control

Active Comparator group

Description:

Written instructions about personal (Kegel) pelvic floor exercises

Treatment:

Other: Written information about kegel exercises