Perinatal and Postpartum Anal Incontinence Clinical Trial
Official title:
Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention