Prenatal Pelvic Floor Prevention(3PN) - Full Text View

Sponsors and Collaborators:	Centre Hospitalier Departemental Felix Guyon CIC-EC Réunion French Institute for Health and Medical Research
Information provided by:	Centre Hospitalier Departemental Felix Guyon
ClinicalTrials.gov Identifier:	NCT00551551

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence Anal Incontinence Genital Prolapse	Other: Pelvic floor muscle training with physiotherapist Other: Written information about kegel exercises	Phase III

MedlinePlus related topics: Exercise and Physical Fitness Pelvic Support Problems Prenatal Care Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial

Further study details as provided by Centre Hospitalier Departemental Felix Guyon:

Primary Outcome Measures:

Urinary incontinence score assessed with ICIQ-SF questionnaire [ Time Frame: one year post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Urinary incontinence prevalence [ Time Frame: pregnancy end, 2 and 12 months post partum ] [ Designated as safety issue: No ]
Other pelvic floor symptoms (anal incontinence, pain, sexual troubles) [ Time Frame: pregnancy end, 2 and 12 months post partum ] [ Designated as safety issue: No ]
Genital prolapse assessed by POP-Q [ Time Frame: 2 months post-partum ] [ Designated as safety issue: No ]
Pelvic floor strength [ Time Frame: 2 months post partum ] [ Designated as safety issue: No ]
Quality of life (Euroquol 5D, Contilife) [ Time Frame: at delivery, 2 and 12 months post partum ] [ Designated as safety issue: No ]
pad-test [ Time Frame: 2 months post partum ] [ Designated as safety issue: No ]
need to medical care [ Time Frame: 12 months post partum ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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 Other: Written information about kegel exercises Information about pelvic floor disorders prevention with personal pelvic floor exercises
Control: Active Comparator Written instructions about personal (Kegel) pelvic floor exercises	Other: Written information about kegel exercises Information about pelvic floor disorders prevention with personal pelvic floor exercises

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551551

Contacts

Contact: Liliane COTTE	+262.262.906.922	l-cotte@chd-fguyon.fr
Contact: Xavier FRITEL, MD	+262.262.905.541	fritel.xavier@orange.fr

Locations

France
CHU Antoine-Béclère	Recruiting
Clamart, France, 92141
Contact: Ramdane Meftali ramdane.meftali@abc.aphp.fr
Principal Investigator: Hervé FERNANDEZ, MD
Sub-Investigator: Xavier DEFFIEUX, MD
Sub-Investigator: Anne-Claire Donnadieu, MD
CH Poissy-Saint-Germain	Recruiting
Saint-Germain, France, 78105
Contact: Fabienne Boirot, MW fabboirot@yahoo.fr
Contact: Isabelle Carré +33.139.275.455
Principal Investigator: Arnaud Fauconnier, MD, PhD
Sub-Investigator: Georges BADER, MD
CHU Caremeau	Recruiting
Nimes, France, 30900
Contact: Sandrine de Tayrac, MW +33.612.536.754 renaud.detayrac@wanadoo.fr
Contact: Clement drc@chu-nimes.fr
Principal Investigator: Renaud de Tayrac, MD, PhD
Sub-Investigator: Pierre Mares, MD
Sub-Investigator: Grégory TRIOPON, MD
CHU Clermont	Recruiting
Clermont-Ferrand, France, 63058
Contact: Annick Viallon aviallon@chu-clermontferrand.fr
Principal Investigator: Joel Amblard, MD
Sub-Investigator: Brigitte Fatton, MD
France, Réunion
CHD Félix Guyon	Recruiting
Saint-Denis, Réunion, France, 97405
Contact: Joelle VASSEUR 262.262.905.004 j-vasseur@chd-fguyon.fr
Contact: Sandrine TERRENTROY 262.262.906.283 3pn@chd-fguyon.fr
Principal Investigator: Xavier FRITEL, MD
Sub-Investigator: Fabrice CUILLER, MD
Sub-Investigator: Ameth Gueye, MD
Sub-Investigator: Magali Hilmi-Leroux, MD

Sponsors and Collaborators

Centre Hospitalier Departemental Felix Guyon

CIC-EC Réunion

French Institute for Health and Medical Research

Investigators

Principal Investigator:

Xavier FRITEL, MD

CHR Réunion, CH Félix Guyon

More Information

Responsible Party:	CHR Réunion, Centre Hospitalier Felix Guyon ( Joelle VASSEUR )
Study ID Numbers:	3PN, AFSSAPS-2007-A00641-52
Study First Received:	October 30, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00551551
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Ministry of Health; France: French Data Protection Authority; France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Departemental Felix Guyon:

Pelvic floor
Kegel exercises
Quality of Life
Pelvic Pain

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Signs and Symptoms
Pelvic Pain
Urologic Diseases
Urination Disorders

Quality of Life
Urinary Incontinence
Pain
Prolapse

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 15, 2009