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Prenatal Pelvic Floor Prevention (3PN)

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00551551
Enrollment
280
Registered
2007-10-31
Start date
2007-11-30
Completion date
2011-09-30
Last updated
2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Incontinence, Genital Prolapse, Urinary Incontinence

Keywords

Pelvic floor, Kegel exercises, Quality of Life, Pelvic Pain

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.

Interventions

OTHERPelvic floor muscle training with physiotherapist

8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife

OTHERWritten information about kegel exercises

Information about pelvic floor disorders prevention with personal pelvic floor exercises

Sponsors

CIC-EC Réunion
CollaboratorUNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Urinary incontinence score assessed with ICIQ-SF questionnaireone year post partum

Secondary

MeasureTime frame
Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)pregnancy end, 2 and 12 months post partum
Genital prolapse assessed by POP-Q2 months post-partum
Pelvic floor strength2 months post partum
Urinary incontinence prevalencepregnancy end, 2 and 12 months post partum
pad-test2 months post partum
need to medical care12 months post partum
Quality of life (Euroquol 5D, Contilife)at delivery, 2 and 12 months post partum

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026