Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
- Conditions
- Obstetric TraumaSphincter Ani Incontinence
- Interventions
- Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT)
- Registration Number
- NCT01672697
- Lead Sponsor
- TriHealth Inc.
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical & Behavioral Therapy Group 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
- Primary Outcome Measures
Name Time Method Fecal Incontinence Quality of Life (FIQOL) 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.
- Secondary Outcome Measures
Name Time Method Anal-rectal manometry (ARM) baseline (2 weeks post delivery) to completion (12 weeks post delivery) 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.
Trial Locations
- Locations (1)
TriHealth
🇺🇸Cincinnati, Ohio, United States