Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Condition: Perinatal and Postpartum Anal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

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.
    


Intervention name(s): Pelvic floor training
Intervention type(s): Other
Intervention description(s): Baseline muscle strength will be measured with the modified Oxford scale. The intervention group will undergo an in-person standardized pelvic strength training session by a trained nurse practitioner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: anal incontinence; pregnancy-associated pelvic floor disorders