Perinatal and Postpartum Anal Incontinence Clinical Trial
Official title:
Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
| Verified date | January 2016 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University Department of Obstetrics and Gynecology Clinic | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University |
United States,
Bø 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. Epub 2006 Nov 21. — View 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. — View Citation
Eason E, Labrecque M, Marcoux S, Mondor M. Anal incontinence after childbirth. CMAJ. 2002 Feb 5;166(3):326-30. — View 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. Erratum in: Am J Obstet Gynecol. 2007 Sep;197(3):333. — View 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. — View 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. Epub 2004 Dec 22. — View 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. — View Citation
Hay-Smith J, Mørkved 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. Review. Update in: Cochrane Database Syst Rev. 2012;10:CD007471. — View 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):169-78; discussion 178-9. doi: 10.1111/1471-0528.12039. Epub 2012 Nov 27. — View Citation
Mørkved S, Bø 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Stafne SN, Salvesen KÅ, Romundstad PR, Torjusen IH, Mørkved 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. — View Citation
Wesnes SL, Rortveit G, Bø K, Hunskaar S. Urinary incontinence during pregnancy. Obstet Gynecol. 2007 Apr;109(4):922-8. — View 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. — View Citation
* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of fecal and/or flatal incontinence | based on standardized questionnaires | 3 months (1st trimester) | No |
| Primary | Incidence of fecal and/or flatal incontinence | based on standardized questionnaires | 6 months (2nd trimester) | No |
| Primary | Incidence of fecal and/or flatal incontinence | based on standardized questionnaires | 9 months (3rd trimester) | No |
| Secondary | Exercise compliance | patient-reported pelvic floor exercise diary | 3 months (1st trimester) | No |
| Secondary | Exercise compliance | patient-reported pelvic floor exercise diary | 6 months (2nd trimester) | No |
| Secondary | Exercise compliance | patient-reported pelvic floor exercise diary | 9 months (3rd trimester) | No |