Perinatal and Postpartum Anal IncontinenceNCT02270008
Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
A study testing Pelvic floor training in people with Perinatal and Postpartum Anal Incontinence, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal and Postpartum Anal Incontinence
- What is being tested?
- Pelvic floor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- parous women
- ages 20-40year old
- a new Ob visit prior to 20 weeks gestation
- confirmed singleton live intrauterine pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Department of Obstetrics and Gynecology Clinic
Atlanta, Georgia, 30322
About this 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.
- Being tested
- Pelvic floor training
- Keywords
- anal incontinence, pregnancy-associated pelvic floor disorders
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor training | Active comparator | 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. Receives: Other: Pelvic floor training |
| Literature-only group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fecal and/or flatal incontinence
based on standardized questionnaires
Measured: 3 months (1st trimester)
Incidence of fecal and/or flatal incontinence
based on standardized questionnaires
Measured: 6 months (2nd trimester)
Incidence of fecal and/or flatal incontinence
based on standardized questionnaires
Measured: 9 months (3rd trimester)
Secondary outcomes (3)
Exercise compliance
patient-reported pelvic floor exercise diary
Measured: 3 months (1st trimester)
Exercise compliance
patient-reported pelvic floor exercise diary
Measured: 6 months (2nd trimester)
Exercise compliance
patient-reported pelvic floor exercise diary
Measured: 9 months (3rd trimester)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Perinatal and Postpartum Anal IncontinenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Karp, Emory University
- Investigators
- Deborah Karp, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270008
- Sponsor's protocol ID
- IRB00065572
- Status last verified
- Jan 2016
- First submitted
- 14 Jul 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17120174Brown 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.
PubMed 19834637Eason E, Labrecque M, Marcoux S, Mondor M. Anal incontinence after childbirth. CMAJ. 2002 Feb 5;166(3):326-30.
PubMed 11868640Fine 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.
PubMed 17618779Fynes 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.
PubMed 10378599Glazener 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.
PubMed 15615766Glazener 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.
PubMed 11557703Hay-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.
PubMed 18843750MacArthur 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.
PubMed 23190303Morkved 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.
PubMed 12576255Pollack 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.
PubMed 15572505Reilly 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.
PubMed 11845813Rortveit 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.
PubMed 12621134Signorello 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.
PubMed 10625261Stafne 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.
PubMed 22804796
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02270008
- Acronym / sponsor ID
- IRB00065572
- Keywords
- anal incontinence, pregnancy-associated pelvic floor disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor training | Active comparator | Other: Pelvic floor trainingThe 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. |
| Literature-only group | No intervention | –The literature-only group will receive a pamphlet with instructions for pelvic floor muscle exercises; however, no in-person training will be administered. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- parous women
- ages 20-40year old
- a new Ob visit prior to 20 weeks gestation
- confirmed singleton live intrauterine pregnancy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor trainingBaseline 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. | Other | Pelvic floor training |
Primary outcome
Incidence of fecal and/or flatal incontinence
Time frame: 3 months (1st trimester)
based on standardized questionnaires
Incidence of fecal and/or flatal incontinence
Time frame: 6 months (2nd trimester)
based on standardized questionnaires
Incidence of fecal and/or flatal incontinence
Time frame: 9 months (3rd trimester)
based on standardized questionnaires
3 secondary outcomes
Exercise compliance
Time frame: 3 months (1st trimester)
Exercise compliance
Time frame: 6 months (2nd trimester)
Exercise compliance
Time frame: 9 months (3rd trimester)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Background: PubMed 17120174Bo 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.
- Background: PubMed 19834637Brown 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.
- Background: PubMed 11868640Eason E, Labrecque M, Marcoux S, Mondor M. Anal incontinence after childbirth. CMAJ. 2002 Feb 5;166(3):326-30.
- Background: PubMed 17618779Fine 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.
- Background: PubMed 10378599Fynes 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.
- Background: PubMed 15615766Glazener 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.
- Background: PubMed 11557703Glazener 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.
- Background: PubMed 18843750Hay-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.
- Background: PubMed 23190303MacArthur 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.
- Background: PubMed 12576255Morkved 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.
- Background: PubMed 15572505Pollack 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.
- Background: PubMed 11845813Reilly 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Karp, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor training in people with Perinatal and Postpartum Anal Incontinence, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fecal and/or flatal incontinence (time frame: 3 months (1st trimester)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270008, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.