Fecal IncontinenceBOOSTNCT01166399
Behavioral Therapy Of Obstetric Sphincter Tears
An observational study of Fecal Incontinence, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
Trial summary
The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- How many people
- 362 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2010to Oct 2012
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects in this trial will be primiparous women who underwent anal sphincter repair at the time of a singleton vaginal delivery. Sphincter tears will be clinically characterized at the time of delivery as <50% tear through the anal sphincter (modified WHO 3a), >50% (modified WHO 3b), or complete tear through the anal sphincter (4th degree).
Who may be able to join
- Vaginal delivery >= 28 weeks singleton gestation
- Documented repair to the anal sphincter at delivery
- First vaginal delivery
- Ambulatory
- Able to give informed consent 6 Adult women >= 18 years of age
- Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
Show all 12Show fewer
- Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
- Pre-pregnancy FI (defined as the leakage of liquid/solid stool and mucus >= once per month for at least 12 weeks prior to this pregnancy)
- Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
- Presence of rectovaginal fistula
- Any participation in other pharmacologic or behavioral studies for FI
- Previous pregnancy >=28 weeks delivered vaginally or by Cesarean section
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
University of California San Diego
La Jolla, California, 92037
Loyola University
Maywood, Illinois, 60153
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study
The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will be enrolled.
Read the detailed description
The primary aim of the "BOOST Cohort Study" is to determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
Secondary aims of the cohort study are:
- To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
- To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
- To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
- To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence,, bowel incontinence,, pelvic floor disorder
- Medical subject headings
- Fecal Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primiparous women with an obstetric anal sphincter tear | Subjects in this trial will be primiparous women who underwent anal sphincter repair at the time of a singleton vaginal delivery. Sphincter tears will be clinically characterized at the time of delivery as <50% tear through the anal sphincter (modified WHO 3a), >50% (modified WHO 3b), or complete tear through the anal sphincter (4th degree). Subjects in this study will not have receive study interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of FI
The primary aim for this study is to determine the incidence of FI symptoms (based on the FISI)at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
Measured: 6 and 12 months postpartum
Secondary outcomes (2)
Incidence of FI
A secondary aim for this study is to determine the incidence of FI symptoms (based on the FISI) at 24 weeks postpartum in primiparous women sustaining an OASI.
Measured: 24 weeks postpartum
Fecal urgency
Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire
Measured: 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- Office of Research on Women's Health (ORWH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Holly E Richter, PhD, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166399
- Sponsor's protocol ID
- 20P01
- Acronym
- BOOST
- Status last verified
- Sep 2020
- First submitted
- 19 Jul 2010
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richter HE, Nager CW, Burgio KL, Whitworth R, Weidner AC, Schaffer J, Zyczynski HM, Norton P, Jelovsek JE, Meikle SF, Spino C, Gantz M, Graziano S, Brubaker L; NICHD Pelvic Floor Disorders Network. Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg. 2015 Jul-Aug;21(4):182-9. doi: 10.1097/SPV.0000000000000160.
PubMed 25679358
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study
- ClinicalTrials.gov ID
- NCT01166399
- Acronym / sponsor ID
- BOOST / 20P01
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence,, bowel incontinence,, pelvic floor disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- Office of Research on Women's Health (ORWH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Jul 2010 (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.
The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will be enrolled.
Detailed description
The primary aim of the "BOOST Cohort Study" is to determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
Secondary aims of the cohort study are:
- To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
- To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
- To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
- To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primiparous women with an obstetric anal sphincter tear | – | –Subjects in this trial will be primiparous women who underwent anal sphincter repair at the time of a singleton vaginal delivery. Sphincter tears will be clinically characterized at the time of delivery as <50% tear through the anal sphincter (modified WHO 3a), >50% (modified WHO 3b), or complete tear through the anal sphincter (4th degree). Subjects in this study will not have receive study interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in this trial will be primiparous women who underwent anal sphincter repair at the time of a singleton vaginal delivery. Sphincter tears will be clinically characterized at the time of delivery as <50% tear through the anal sphincter (modified WHO 3a), >50% (modified WHO 3b), or complete tear through the anal sphincter (4th degree).
Key inclusion criteria (12 listed)
- Vaginal delivery >= 28 weeks singleton gestation
- Documented repair to the anal sphincter at delivery
- First vaginal delivery
- Ambulatory
- Able to give informed consent 6 Adult women >= 18 years of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of FI
Time frame: 6 and 12 months postpartum
The primary aim for this study is to determine the incidence of FI symptoms (based on the FISI)at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
2 secondary outcomes
Incidence of FI
Time frame: 24 weeks postpartum
Fecal urgency
Time frame: 24 weeks postpartum
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 10 Sep 2020.
- Derived from this study: PubMed 25679358Richter HE, Nager CW, Burgio KL, Whitworth R, Weidner AC, Schaffer J, Zyczynski HM, Norton P, Jelovsek JE, Meikle SF, Spino C, Gantz M, Graziano S, Brubaker L; NICHD Pelvic Floor Disorders Network. Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg. 2015 Jul-Aug;21(4):182-9. doi: 10.1097/SPV.0000000000000160.
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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.
Holly E Richter, PhD, MD study chair
University of Alabama at Birmingham
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence, run by NICHD Pelvic Floor Disorders Network at 8 sites 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 12 inclusion and 0 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 FI (time frame: 6 and 12 months postpartum). 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 NCT01166399, which also lists 1 linked publication.
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 10 Sep 2020.