Clinical trial NCT01672697: Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sphincter Ani Incontinence
Obstetric Trauma
Keywords: anal incontinence
genital trauma
physical therapy
anal manometry
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal Incontinence Quality of Life (FIQOL)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
Secondary outcomes:
measure: Anal-rectal manometry (ARM)
timeFrame: baseline (2 weeks post delivery) to completion (12 weeks post delivery)
Other outcomes:
measure: Fecal Incontinence Severity Index (FISI)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
measure: Short Form-12 (SF-12)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
measure: Female Sexual Function Index (FSFI)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
measure: Urogenital Distress Inventory (UDI-6)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
measure: Incontinence Impact Questionnaire-7 (IIQ-7)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
measure: Vaginal Electromyography (EMG)
timeFrame: baseline (2-weeks post delivery) to completion (12-weeks post delivery)
Locations:
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Rachel Pauls, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Oakley 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.