Prenatal Pelvic Floor Prevention (3PN)

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551551
• Other study ID #: 3PN
• Secondary ID: AFSSAPS-2007-A00
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2007
• Last updated: July 25, 2013
• Start date: November 2007
• Est. completion date: September 2011

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Ministry of HealthFrance: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence
• Genital Prolapse
• Urinary Incontinence

Intervention

Other:
• Pelvic floor muscle training with physiotherapist
8 sessions of 20-30 minutes each between 24 and 36 weeks of gestation with a physiotherapist or midwife
• Written information about kegel exercises
Information about pelvic floor disorders prevention with personal pelvic floor exercises

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	CIC-EC Réunion, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

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