Urinary Incontinence Clinical Trial
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | CHU Antoine-Béclère | Clamart | |
France | CHU Clermont | Clermont-Ferrand | |
France | CHU Caremeau | Nimes | |
France | CHR Réunion, CH Félix-Guyon | Saint-Denis | Réunion |
France | CH Poissy-Saint-Germain | Saint-Germain |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de la Réunion | CIC-EC Réunion, Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary incontinence score assessed with ICIQ-SF questionnaire | one year post partum | No | |
Secondary | Urinary incontinence prevalence | pregnancy end, 2 and 12 months post partum | No | |
Secondary | Other pelvic floor symptoms (anal incontinence, pain, sexual troubles) | pregnancy end, 2 and 12 months post partum | No | |
Secondary | Genital prolapse assessed by POP-Q | 2 months post-partum | No | |
Secondary | Pelvic floor strength | 2 months post partum | No | |
Secondary | Quality of life (Euroquol 5D, Contilife) | at delivery, 2 and 12 months post partum | No | |
Secondary | pad-test | 2 months post partum | No | |
Secondary | need to medical care | 12 months post partum | No |
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