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| ID | Type | Description | Link |
|---|---|---|---|
| AFSSAPS-2007-A00641-52 |
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| Name | Class |
|---|---|
| CIC-EC Réunion | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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:
Secondary criteria:
Progress:
Study length:
Number of subjects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rééducation | Experimental | 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 | Active Comparator | Written instructions about personal (Kegel) pelvic floor exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle training with physiotherapist | Other | 8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence score assessed with ICIQ-SF questionnaire | one year post partum |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier FRITEL, MD, PhD | CHR Réunion, CH Félix Guyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Réunion, CH Félix-Guyon | Saint-Denis | Réunion | 97405 | France | ||
| CHU Antoine-Béclère |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32378735 | Derived | Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4. | |
| 26241428 | Derived |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D004688 | Encopresis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059825 | Physical Therapists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Written information about kegel exercises | Other | Information about pelvic floor disorders prevention with personal pelvic floor exercises |
|
|
| 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 |
| Clamart |
| 92141 |
| France |
| CHU Clermont | Clermont-Ferrand | 63058 | France |
| CHU Caremeau | Nîmes | 30900 | France |
| CH Poissy-Saint-Germain | Saint-Germain | 78105 | France |
| Fritel X, de Tayrac R, Bader G, Savary D, Gueye A, Deffieux X, Fernandez H, Richet C, Guilhot J, Fauconnier A. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):370-377. doi: 10.1097/AOG.0000000000000972. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |