Clinical trial NCT00551551: Prenatal Pelvic Floor Prevention (3PN)
Official title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Anal Incontinence
Genital Prolapse
Keywords: Pelvic floor
Kegel exercises
Quality of Life
Pelvic Pain
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: CIC-EC Réunion
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2007-10-31
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Urinary incontinence score assessed with ICIQ-SF questionnaire
timeFrame: one year post partum
Secondary outcomes:
measure: Urinary incontinence prevalence
timeFrame: pregnancy end, 2 and 12 months post partum
measure: Other pelvic floor symptoms (anal incontinence, pain, sexual troubles)
timeFrame: pregnancy end, 2 and 12 months post partum
measure: Genital prolapse assessed by POP-Q
timeFrame: 2 months post-partum
measure: Pelvic floor strength
timeFrame: 2 months post partum
measure: Quality of life (Euroquol 5D, Contilife)
timeFrame: at delivery, 2 and 12 months post partum
measure: pad-test
timeFrame: 2 months post partum
measure: need to medical care
timeFrame: 12 months post partum
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: CHR Réunion, CH Félix-Guyon
state: Réunion
city: Clamart
country: France
facility: CHU Antoine-Béclère
city: Clermont-Ferrand
country: France
facility: CHU Clermont
city: Nimes
country: France
facility: CHU Caremeau
city: Saint-Germain
country: France
facility: CH Poissy-Saint-Germain
Study officials:
affiliation: CHR Réunion, CH Félix Guyon
name: Xavier FRITEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.