Physical Therapy for Women With Obstetric Trauma and Anal Incontinence

NCT01672697 | Completed

• 1 other identifier: 12005-TriHealth
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Sphincter Ani Incontinence; Obstetric Trauma

Keywords

anal incontinence; genital trauma; physical therapy; anal manometry

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline (2-weeks post delivery) to completion (12-weeks post delivery)

Secondary Outcomes (1)

• Anal-rectal manometry (ARM)

  baseline (2 weeks post delivery) to completion (12 weeks post delivery)

Other Outcomes (6)

• Fecal Incontinence Severity Index (FISI)

  baseline (2-weeks post delivery) to completion (12-weeks post delivery)

• Short Form-12 (SF-12)

  baseline (2-weeks post delivery) to completion (12-weeks post delivery)

• Female Sexual Function Index (FSFI)

  baseline (2-weeks post delivery) to completion (12-weeks post delivery)

Study Arms (2)

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

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

Interventions

Physical Therapy (PT) and Behavioral Therapy (BT) BEHAVIORAL

1. 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.

Also known as: Internal Pelvic Floor Physical Therapy

Physical & Behavioral Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• completed weeks
• Singleton or vaginal delivery of multiple gestation
• Able to read and speak the English language

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45220, United States

Location

Related Publications (2)

• 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.

  PMID: 32378735 DERIVED

• 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.

  PMID: 26829343 DERIVED

MeSH Terms

Conditions

Encopresis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Rachel Pauls, MD

  TriHealth Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 27, 2012
• Study Start: September 12, 2012
• Primary Completion: March 17, 2016
• Study Completion: March 17, 2016
• Last Updated: January 17, 2019

Record last verified: 2017-03

Locations

US (1)