Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Gastrointestinal, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | September 12, 2012 |
| End Date: | March 17, 2016 |
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
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
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
