Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
- Enrollment
- 280
- Locations
- 5
- Primary Endpoint
- Urinary incontinence score assessed with ICIQ-SF questionnaire
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Urinary incontinence score assessed with ICIQ-SF questionnaire
Time Frame: one year post partum
Secondary Outcomes
- 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)