search
Back to results

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

Primary Purpose

Perinatal and Postpartum Anal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic floor training
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal and Postpartum Anal Incontinence focused on measuring anal incontinence, pregnancy-associated pelvic floor disorders

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Emory University Department of Obstetrics and Gynecology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pelvic floor training

Literature-only group

Arm Description

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.

The literature-only group will receive a pamphlet with instructions for pelvic floor muscle exercises; however, no in-person training will be administered.

Outcomes

Primary Outcome Measures

Incidence of fecal and/or flatal incontinence
based on standardized questionnaires
Incidence of fecal and/or flatal incontinence
based on standardized questionnaires
Incidence of fecal and/or flatal incontinence
based on standardized questionnaires

Secondary Outcome Measures

Exercise compliance
patient-reported pelvic floor exercise diary
Exercise compliance
patient-reported pelvic floor exercise diary
Exercise compliance
patient-reported pelvic floor exercise diary

Full Information

First Posted
July 14, 2014
Last Updated
January 27, 2016
Sponsor
Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT02270008
Brief Title
Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Official Title
Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal and Postpartum Anal Incontinence
Keywords
anal incontinence, pregnancy-associated pelvic floor disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Literature-only group
Arm Type
No Intervention
Arm Description
The literature-only group will receive a pamphlet with instructions for pelvic floor muscle exercises; however, no in-person training will be administered.
Intervention Type
Other
Intervention Name(s)
Pelvic floor training
Intervention Description
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 Outcome Measure Information:
Title
Incidence of fecal and/or flatal incontinence
Description
based on standardized questionnaires
Time Frame
3 months (1st trimester)
Title
Incidence of fecal and/or flatal incontinence
Description
based on standardized questionnaires
Time Frame
6 months (2nd trimester)
Title
Incidence of fecal and/or flatal incontinence
Description
based on standardized questionnaires
Time Frame
9 months (3rd trimester)
Secondary Outcome Measure Information:
Title
Exercise compliance
Description
patient-reported pelvic floor exercise diary
Time Frame
3 months (1st trimester)
Title
Exercise compliance
Description
patient-reported pelvic floor exercise diary
Time Frame
6 months (2nd trimester)
Title
Exercise compliance
Description
patient-reported pelvic floor exercise diary
Time Frame
9 months (3rd trimester)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Karp, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Department of Obstetrics and Gynecology Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17120174
Citation
Bo K, A H Haakstad L, Voldner N. Do pregnant women exercise their pelvic floor muscles? Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jul;18(7):733-6. doi: 10.1007/s00192-006-0235-2. Epub 2006 Nov 21.
Results Reference
background
PubMed Identifier
19834637
Citation
Brown SJ, Donath S, MacArthur C, McDonald EA, Krastev AH. Urinary incontinence in nulliparous women before and during pregnancy: prevalence, incidence, and associated risk factors. Int Urogynecol J. 2010 Feb;21(2):193-202. doi: 10.1007/s00192-009-1011-x. Epub 2009 Oct 16.
Results Reference
background
PubMed Identifier
11868640
Citation
Eason E, Labrecque M, Marcoux S, Mondor M. Anal incontinence after childbirth. CMAJ. 2002 Feb 5;166(3):326-30.
Results Reference
background
PubMed Identifier
17618779
Citation
Fine P, Burgio K, Borello-France D, Richter H, Whitehead W, Weber A, Brown M; Pelvic Floor Disorders Network. Teaching and practicing of pelvic floor muscle exercises in primiparous women during pregnancy and the postpartum period. Am J Obstet Gynecol. 2007 Jul;197(1):107.e1-5. doi: 10.1016/j.ajog.2007.02.052. Erratum In: Am J Obstet Gynecol. 2007 Sep;197(3):333.
Results Reference
background
PubMed Identifier
10378599
Citation
Fynes MM, Marshall K, Cassidy M, Behan M, Walsh D, O'Connell PR, O'Herlihy C. A prospective, randomized study comparing the effect of augmented biofeedback with sensory biofeedback alone on fecal incontinence after obstetric trauma. Dis Colon Rectum. 1999 Jun;42(6):753-8; discussion 758-61. doi: 10.1007/BF02236930.
Results Reference
background
PubMed Identifier
15615766
Citation
Glazener CM, Herbison GP, MacArthur C, Grant A, Wilson PD. Randomised controlled trial of conservative management of postnatal urinary and faecal incontinence: six year follow up. BMJ. 2005 Feb 12;330(7487):337. doi: 10.1136/bmj.38320.613461.82. Epub 2004 Dec 22.
Results Reference
background
PubMed Identifier
11557703
Citation
Glazener CM, Herbison GP, Wilson PD, MacArthur C, Lang GD, Gee H, Grant AM. Conservative management of persistent postnatal urinary and faecal incontinence: randomised controlled trial. BMJ. 2001 Sep 15;323(7313):593-6. doi: 10.1136/bmj.323.7313.593.
Results Reference
background
PubMed Identifier
18843750
Citation
Hay-Smith J, Morkved S, Fairbrother KA, Herbison GP. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD007471. doi: 10.1002/14651858.CD007471.
Results Reference
background
PubMed Identifier
23190303
Citation
MacArthur C, Wilson D, Herbison P, Lancashire RJ, Hagen S, Toozs-Hobson P, Dean N, Glazener C; ProLong study group. Faecal incontinence persisting after childbirth: a 12 year longitudinal study. BJOG. 2013 Jan;120(2):169-179. doi: 10.1111/1471-0528.12039. Epub 2012 Nov 27.
Results Reference
background
PubMed Identifier
12576255
Citation
Morkved S, Bo K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. doi: 10.1016/s0029-7844(02)02711-4.
Results Reference
background
PubMed Identifier
15572505
Citation
Pollack J, Nordenstam J, Brismar S, Lopez A, Altman D, Zetterstrom J. Anal incontinence after vaginal delivery: a five-year prospective cohort study. Obstet Gynecol. 2004 Dec;104(6):1397-402. doi: 10.1097/01.AOG.0000147597.45349.e8.
Results Reference
background
PubMed Identifier
11845813
Citation
Reilly ET, Freeman RM, Waterfield MR, Waterfield AE, Steggles P, Pedlar F. Prevention of postpartum stress incontinence in primigravidae with increased bladder neck mobility: a randomised controlled trial of antenatal pelvic floor exercises. BJOG. 2002 Jan;109(1):68-76. doi: 10.1111/j.1471-0528.2002.t01-1-01116.x.
Results Reference
background
PubMed Identifier
12621134
Citation
Rortveit G, Daltveit AK, Hannestad YS, Hunskaar S; Norwegian EPINCONT Study. Urinary incontinence after vaginal delivery or cesarean section. N Engl J Med. 2003 Mar 6;348(10):900-7. doi: 10.1056/NEJMoa021788.
Results Reference
background
PubMed Identifier
10625261
Citation
Signorello LB, Harlow BL, Chekos AK, Repke JT. Midline episiotomy and anal incontinence: retrospective cohort study. BMJ. 2000 Jan 8;320(7227):86-90. doi: 10.1136/bmj.320.7227.86.
Results Reference
background
PubMed Identifier
22804796
Citation
Stafne SN, Salvesen KA, Romundstad PR, Torjusen IH, Morkved S. Does regular exercise including pelvic floor muscle training prevent urinary and anal incontinence during pregnancy? A randomised controlled trial. BJOG. 2012 Sep;119(10):1270-80. doi: 10.1111/j.1471-0528.2012.03426.x. Epub 2012 Jul 17.
Results Reference
background
PubMed Identifier
17400855
Citation
Wesnes SL, Rortveit G, Bo K, Hunskaar S. Urinary incontinence during pregnancy. Obstet Gynecol. 2007 Apr;109(4):922-8. doi: 10.1097/01.AOG.0000257120.23260.00.
Results Reference
background
PubMed Identifier
21988063
Citation
Whitford HM, Jones M. An exploration of the motivation of pregnant women to perform pelvic floor exercises using the revised theory of planned behaviour. Br J Health Psychol. 2011 Nov;16(4):761-78. doi: 10.1111/j.2044-8287.2010.02013.x. Epub 2011 Jan 13.
Results Reference
background
PubMed Identifier
32378735
Citation
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs