Skip to content

Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study

Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02270008
Enrollment
15
Registered
2014-10-21
Start date
2014-10-31
Completion date
2015-06-30
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal and Postpartum Anal Incontinence

Keywords

anal incontinence, pregnancy-associated pelvic floor disorders

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.

Interventions

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.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of fecal and/or flatal incontinence3 months (1st trimester)based on standardized questionnaires

Secondary

MeasureTime frameDescription
Exercise compliance3 months (1st trimester)patient-reported pelvic floor exercise diary

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026