Sphincter Ani IncontinenceNCT01672697
Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
A study testing Physical Therapy (PT) and Behavioral Therapy (BT) in people with Sphincter Ani Incontinence and Obstetric Trauma, run by TriHealth Inc. at 1 site in United States.
Trial summary
Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sphincter Ani Incontinence, Obstetric Trauma
- What is being tested?
- Physical Therapy (PT) and Behavioral Therapy (BT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2012to 17 Mar 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primiparous women aged 18 years of older
- Vaginal delivery, vacuum-assisted-vaginal-delivery (VAVD), or forceps-assisted-vaginal-delivery (FAVD) of a neonate of gestational age:
- 27 completed weeks
- Singleton or vaginal delivery of multiple gestation
- Able to read and speak the English language
Who cannot join
- Unable to comply with physical therapy or office visits
- Unreliable transportation
- Preexisting neurologic, musculoskeletal or neuromuscular disorder rendering them unable to perform physical therapy requirements
- Cesarean delivery
- History of prior surgery for anorectal incontinence (i.e. sphincteroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Therapy on Pelvic Floor Symptoms and Quality of Life in Postpartum Women Following Severe Perineal Trauma: a Randomized Controlled Trial
Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries
Read the detailed description
This is a prospective trial involving 65 woman who sustained a severe laceration or episiotomy during their first vaginal delivery to determine if postpartum intervention with physical/behavioral therapy improves their quality of life in regard to anal incontinence. The primary outcome measure is functional and based on a change in score of the Fecal Incontinence Quality of Life (FIQOL) validated questionnaire from baseline (2-weeks after delivery date) to study completion (12-weeks after delivery date). The secondary outcome measure is physiologic and reflects a change in anal sphincter resting tone from baseline to study completion.
After the screening questionnaires to determine eligibility in the study, each study subject will be consented for participation then undergo a baseline physical exam (including pelvic exam and rectal exam) at a range of 2- to 4- weeks after delivery date. In addition, after this initial exam, all women will be randomized immediately to receive (1) no further treatments, or (2) physical and behavioral therapy.
The investigators will study these two groups of women for 24 total weeks after the date of delivery. The intervention group will include patients randomized to receiving PT/BT for 4 weekly sessions after their vaginal delivery and laceration (episiotomy) repair. The control group (no intervention) will include patients randomized to receiving the standard of care (no physical or behavioral therapy) after their vaginal delivery and laceration (episiotomy) repair.
Each group will undergo the baseline testing: a pelvic exam (to measure the strength of your muscles) and anal-rectal manometry (i.e. rectal exam with insertion of a small sensor to measure the strength of your sphincter); and be asked to complete a series of brief questionnaires. These questionnaires will be administered again to both groups at 6-weeks, 12-weeks, and 24-weeks after their delivery date. Study completion physical exams including a repeat pelvic exam and repeat anal-rectal manometry will be conducted at 12-weeks after delivery date.
- Conditions
- Sphincter Ani Incontinence, Obstetric Trauma
- Being tested
- Physical Therapy (PT) and Behavioral Therapy (BT)
- Keywords
- anal incontinence, genital trauma, physical therapy, anal manometry
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy (PT) and Behavioral Therapy (BT)Behavioural
Also called Internal Pelvic Floor Physical Therapy
- Physical Therapy (PT) Protocol states that each participant in the treatment arm only will undergo a total of four 45-minute sessions with a certified pelvic floor (PF) physical therapist over the course of the 12 weeks. Routine monitoring of patient progress will be performed. Each session includes using the body core muscles and internal pelvic floor muscles, focusing on PF protection techniques, PF exercises, Core exercises, progression to full ADLs(activities of daily living), and an exercise routine.
- Behavioral Therapy (BT) Instructions are given only to participants in the treatment arm after randomization at week-2 visit; handout provides specific instructions about appropriate diet, hygiene and level of activity during the 12 weeks of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Physical & Behavioral Therapy Group | Experimental | Intervention Group: Randomized to Physical Therapy (PT)
1. 2-week visit which includes: Demographic Data, Physical Exam, ehavioral Therapy (BT) handouts Functional questionnaires administered Physiologic measurements obtained
2. Follow-up Evaluation-6-week visit PT session #1 Functional questionnaires administered
3. Follow-up Evaluation-8-week visit PT session #2
4. Follow-up Evaluation-10-week visit PT session #3
5. Study Completion Visit-12-week visit Functional questionnaires administered PT session #4 Physiologic measurements Physical Exam
6. Long-term Follow-up-24-weeks Functional questionnaires administered by mail Receives: Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT) |
| Control Group | No intervention | Control Group: 1. Baseline Data obtained at 2-week visit Demographic Data General Physical Exam findings Functional questionnaires administered in person (FIQOL, FISI, SF-12, FSFI, UDI-6, IIQ-7) Physiologic measurements obtained (Vaginal EMG, Anal-rectal manometry) 2. Follow-up Evaluation at 6-week visit Functional questionnaires administered in person at patient's previously scheduled postpartum office visit with primary Ob/Gyn or by mail 3. Study Completion Visit at 12-week visit Functional questionnaires administered Physiologic measurements obtained Physical Exam findings 4. Long-term Follow-up at 24-weeks - Functional questionnaires administered by mail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Incontinence Quality of Life (FIQOL)
The Fecal Incontinence Quality of Life Scale (FIQOL) is a 29-item instrument developed with the support of the American Society of Colon and Rectal Surgeons that measures the impact of anal incontinence over four domains: Lifestyle, Coping/behavior, Depression/self-perceptions, and Embarrassment. The FIQL has demonstrated validity and reliability.
Measured: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
Secondary outcomes (1)
Anal-rectal manometry (ARM)
Anal Rectal Manometry (ARM) will be completed by all participants at baseline (week 2 visit) and completion (week 12 visit); a small caliber soft flexible disposable air-filled catheter will be placed in the patient's rectum to a depth of 5cm in order to obtain the resting tone and squeezing pressure of the sphincter, per the protocol and patient preparatory instructions as provided by Laborie Medical Technologies (Mississauga, Ontario, Canada) for use with their Triton Aquarius Urodynamics® chair and compatible UDS120 software.
Measured: baseline (2 weeks post delivery) to completion (12 weeks post delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study start12 Sep 2012
- Primary completion17 Mar 2016
- Study completion17 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sphincter Ani 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Study director, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672697
- Sponsor's protocol ID
- 12005-TriHealth
- Status last verified
- Mar 2017
- First submitted
- 21 Aug 2012
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32378735Oakley SH, Ghodsi VC, Crisp CC, Estanol MV, Westermann LB, Novicki KM, Kleeman SD, Pauls RN. Impact of Pelvic Floor Physical Therapy on Quality of Life and Function After Obstetric Anal Sphincter Injury: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):205-13. doi: 10.1097/SPV.0000000000000255.
PubMed 26829343
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on Pelvic Floor Symptoms and Quality of Life in Postpartum Women Following Severe Perineal Trauma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01672697
- Acronym / sponsor ID
- 12005-TriHealth
- Conditions
- Sphincter Ani Incontinence, Obstetric Trauma
- Keywords
- anal incontinence, genital trauma, physical therapy, anal manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 12 Sep 2012 (actual)
- Primary completion
- 17 Mar 2016 (actual)
- Study completion
- 17 Mar 2016 (actual)
- First posted
- 27 Aug 2012 (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.
Our primary objective is to determine if physical therapy (PT) and behavioral therapy (BT) in the post-partum period after a vaginal delivery complicated by genital trauma help to improve a woman's quality of life, specifically in regard to anal incontinence. To be able to study this, the investigators need to know how well the muscles of a woman's pelvic floor function after a vaginal delivery and this requires measuring their strength during a pelvic exam. At present, there are no studies that have looked at whether the intervention of PT/BT improves a woman's anal incontinence quality of life after sustaining genital trauma during vaginal deliveries
Detailed description
This is a prospective trial involving 65 woman who sustained a severe laceration or episiotomy during their first vaginal delivery to determine if postpartum intervention with physical/behavioral therapy improves their quality of life in regard to anal incontinence. The primary outcome measure is functional and based on a change in score of the Fecal Incontinence Quality of Life (FIQOL) validated questionnaire from baseline (2-weeks after delivery date) to study completion (12-weeks after delivery date). The secondary outcome measure is physiologic and reflects a change in anal sphincter resting tone from baseline to study completion.
After the screening questionnaires to determine eligibility in the study, each study subject will be consented for participation then undergo a baseline physical exam (including pelvic exam and rectal exam) at a range of 2- to 4- weeks after delivery date. In addition, after this initial exam, all women will be randomized immediately to receive (1) no further treatments, or (2) physical and behavioral therapy.
The investigators will study these two groups of women for 24 total weeks after the date of delivery. The intervention group will include patients randomized to receiving PT/BT for 4 weekly sessions after their vaginal delivery and laceration (episiotomy) repair. The control group (no intervention) will include patients randomized to receiving the standard of care (no physical or behavioral therapy) after their vaginal delivery and laceration (episiotomy) repair.
Each group will undergo the baseline testing: a pelvic exam (to measure the strength of your muscles) and anal-rectal manometry (i.e. rectal exam with insertion of a small sensor to measure the strength of your sphincter); and be asked to complete a series of brief questionnaires. These questionnaires will be administered again to both groups at 6-weeks, 12-weeks, and 24-weeks after their delivery date. Study completion physical exams including a repeat pelvic exam and repeat anal-rectal manometry will be conducted at 12-weeks after delivery date.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical & Behavioral Therapy Group | Experimental | Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT)Intervention Group: Randomized to Physical Therapy (PT) 1. 2-week visit which includes: Demographic Data, Physical Exam, ehavioral Therapy (BT) handouts Functional questionnaires administered Physiologic measurements obtained 2. Follow-up Evaluation-6-week visit PT session #1 Functional questionnaires administered 3. Follow-up Evaluation-8-week visit PT session #2 4. Follow-up Evaluation-10-week visit PT session #3 5. Study Completion Visit-12-week visit Functional questionnaires administered PT session #4 Physiologic measurements Physical Exam 6. Long-term Follow-up-24-weeks Functional questionnaires administered by mail |
| Control Group | No intervention | –Control Group: 1. Baseline Data obtained at 2-week visit Demographic Data General Physical Exam findings Functional questionnaires administered in person (FIQOL, FISI, SF-12, FSFI, UDI-6, IIQ-7) Physiologic measurements obtained (Vaginal EMG, Anal-rectal manometry) 2. Follow-up Evaluation at 6-week visit Functional questionnaires administered in person at patient's previously scheduled postpartum office visit with primary Ob/Gyn or by mail 3. Study Completion Visit at 12-week visit Functional questionnaires administered Physiologic measurements obtained Physical Exam findings 4. Long-term Follow-up at 24-weeks - Functional questionnaires administered by mail |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primiparous women aged 18 years of older
- Vaginal delivery, vacuum-assisted-vaginal-delivery (VAVD), or forceps-assisted-vaginal-delivery (FAVD) of a neonate of gestational age:
- 27 completed weeks
- Singleton or vaginal delivery of multiple gestation
- Able to read and speak the English language
Key exclusion criteria (5 listed)
- Unable to comply with physical therapy or office visits
- Unreliable transportation
- Preexisting neurologic, musculoskeletal or neuromuscular disorder rendering them unable to perform physical therapy requirements
- Cesarean delivery
- History of prior surgery for anorectal incontinence (i.e. sphincteroplasty
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 |
|---|---|---|
| Physical Therapy (PT) and Behavioral Therapy (BT)Also: Internal Pelvic Floor Physical Therapy1. Physical Therapy (PT) Protocol states that each participant in the treatment arm only will undergo a total of four 45-minute sessions with a certified pelvic floor (PF) physical therapist over the course of the 12 weeks. Routine monitoring of patient progress will be performed. Each session includes using the body core muscles and internal pelvic floor muscles, focusing on PF protection techniques, PF exercises, Core exercises, progression to full ADLs(activities of daily living), and an exercise routine. 2. Behavioral Therapy (BT) Instructions are given only to participants in the treatment arm after randomization at week-2 visit; handout provides specific instructions about appropriate diet, hygiene and level of activity during the 12 weeks of enrollment. | Behavioural | Physical & Behavioral Therapy Group |
Primary outcome
Fecal Incontinence Quality of Life (FIQOL)
Time frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
The Fecal Incontinence Quality of Life Scale (FIQOL) is a 29-item instrument developed with the support of the American Society of Colon and Rectal Surgeons that measures the impact of anal incontinence over four domains: Lifestyle, Coping/behavior, Depression/self-perceptions, and Embarrassment. The FIQL has demonstrated validity and reliability.
1 secondary outcome
Anal-rectal manometry (ARM)
Time frame: baseline (2 weeks post delivery) to completion (12 weeks post delivery)
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 17 Jan 2019.
- Derived from this study: PubMed 32378735Woodley 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.
- Derived from this study: PubMed 26829343Oakley SH, Ghodsi VC, Crisp CC, Estanol MV, Westermann LB, Novicki KM, Kleeman SD, Pauls RN. Impact of Pelvic Floor Physical Therapy on Quality of Life and Function After Obstetric Anal Sphincter Injury: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):205-13. doi: 10.1097/SPV.0000000000000255.
- Individual participant dataSharing planned: Undecided
Related trials for Sphincter Ani Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
RecruitingObservational study
Patient Reported Outcomes Following Cancer of the Rectum
Sphincter Ani Incontinence, Rectal Cancer
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.
Rachel Pauls, MD study director
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy (PT) and Behavioral Therapy (BT) in people with Sphincter Ani Incontinence and Obstetric Trauma, run by TriHealth Inc. 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 5 inclusion and 5 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 17 Jan 2019. 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?
Fecal Incontinence Quality of Life (FIQOL) (time frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)). 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 NCT01672697, which also lists 2 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 17 Jan 2019.