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

Study Overview
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Brief Summary
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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.

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

Conditions
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Perinatal and Postpartum Anal Incontinence

Intervention / Treatment
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* Other: Pelvic floor training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic floor training<br>The intervention group will undergo an in-person standardized training session by a trained nurse practitioner. The intervention is the pelvic floor training session. They will then be asked to continue muscle training at home at regular intervals and asked to log their exercises on a standardized exercise diary that is provided to them. | Other: Pelvic floor training<br>* 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.<br>|
| No Intervention: Literature-only group<br>The literature-only group will receive a pamphlet with instructions for pelvic floor muscle exercises; however, no in-person training will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of fecal and/or flatal incontinence | based on standardized questionnaires | 3 months (1st trimester) | 
| Incidence of fecal and/or flatal incontinence | based on standardized questionnaires | 6 months (2nd trimester) | 
| Incidence of fecal and/or flatal incontinence | based on standardized questionnaires | 9 months (3rd trimester) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise compliance | patient-reported pelvic floor exercise diary | 3 months (1st trimester) | 
| Exercise compliance | patient-reported pelvic floor exercise diary | 6 months (2nd trimester) | 
| Exercise compliance | patient-reported pelvic floor exercise diary | 9 months (3rd trimester) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal incontinence, pregnancy-associated pelvic floor disorders