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Completed

NCT Number: NCT02270008

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Department of Obstetrics and Gynecology Clinic

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor training

Other

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.

Primary outcomes

  1. Incidence of fecal and/or flatal incontinence

    Time frame: 3 months (1st trimester)

    based on standardized questionnaires

  2. Incidence of fecal and/or flatal incontinence

    Time frame: 6 months (2nd trimester)

    based on standardized questionnaires

  3. Incidence of fecal and/or flatal incontinence

    Time frame: 9 months (3rd trimester)

    based on standardized questionnaires

Secondary outcomes

  1. Exercise compliance

    Time frame: 3 months (1st trimester)

    patient-reported pelvic floor exercise diary

  2. Exercise compliance

    Time frame: 6 months (2nd trimester)

    patient-reported pelvic floor exercise diary

  3. Exercise compliance

    Time frame: 9 months (3rd trimester)

    patient-reported pelvic floor exercise diary

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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