Clinical trial NCT02270008: Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Official title: Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal and Postpartum Anal Incontinence
Keywords: anal incontinence
pregnancy-associated pelvic floor disorders
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy. It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene and increased risk for genitourinary tract infection. These women suffer from a combination of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses. Though anal incontinence may subside in the postpartum period, a subset of women will have continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or as they age. As of December 2012, only one study has explored the effects of pelvic floor muscle training (PFMT) on reducing the development of this condition in the pregnant population. However, that study took place in Scandinavia with little demographic correlation to a US population and lacked postpartum followup. Although their results showed little effect of PFMT on anal incontinence, they recommended further research to be performed prior to making definitive conclusions.

Multiple studies have explored the effects of PFMT on urinary incontinence, and the general consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as an initial test to explore whether such a positive relationship holds for anal incontinence throughout pregnancy and postpartum period for a diverse population. The format will be a prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle training course at the first prenatal visit with at home instructions for continued exercise. This group will be compared to a control group which receives a hand-out regarding PFMT but no personalized instruction. The progress of the participants and their symptoms of incontinence will be monitored during pregnancy and at the postpartum visit using standardized validated pelvic floor questionnaires, based on previously designed surveys. A sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and "control or standard therapy" group. The investigators' hypothesis is that the intervention group will show a 50% risk reduction, similar to the urinary incontinence studies. The results of this study will then allow us to design a broader intervention study for which to study the effects of PFMT and anal incontinence during pregnancy and the postpartum period.


Eligibility criteria: Inclusion Criteria:

* parous women
* ages 20-40year old
* a new Ob visit prior to 20 weeks gestation
* confirmed singleton live intrauterine pregnancy

Exclusion Criteria:

* prior history of anal incontinence or prolapse
* history of surgery or procedures for urinary or anal incontinence or pelvic organ prolapse
* tobacco use
* diabetes mellitus
* history of sexual trauma
* chronic cough
* chronic constipation based on Rome criteria
* known connective tissue disorder

Primary outcomes:
measure: Incidence of fecal and/or flatal incontinence
timeFrame: 3 months (1st trimester)
measure: Incidence of fecal and/or flatal incontinence
timeFrame: 6 months (2nd trimester)
measure: Incidence of fecal and/or flatal incontinence
timeFrame: 9 months (3rd trimester)
Secondary outcomes:
measure: Exercise compliance
timeFrame: 3 months (1st trimester)
measure: Exercise compliance
timeFrame: 6 months (2nd trimester)
measure: Exercise compliance
timeFrame: 9 months (3rd trimester)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Department of Obstetrics and Gynecology Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Deborah Karp, MD
role: PRINCIPAL_INVESTIGATOR
References:
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