Trial record 3 of 421 for:    wounds and injuries AND (woman OR women OR female)

Physical Therapy for Women With Obstetric Trauma and Anal Incontinence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TriHealth Medical Education Research Fund (MERF)
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01672697
First received: August 21, 2012
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Anal Incontinence
Obstetric Trauma
Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Fecal Incontinence Quality of Life (FIQOL) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    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:
  • Anal-rectal manometry (ARM) [ Time Frame: baseline (2 weeks post delivery) to completion (12 weeks post delivery) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Fecal Incontinence Severity Index (FISI) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    The Fecal Incontinence Severity Index (FISI) is a frequency matrix developed with support of the American Society of Colon and Rectal Surgeons that assigns patient-weighted values to various frequencies and types of incontinence. The FISI has demonstrated correlation with the FIQL.

  • Short Form-12 (SF-12) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    The Short Form-12 (SF-12) is a brief 12-item questionnaire to assess a subject's current general health.

  • Female Sexual Function Index (FSFI) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    The Female Sexual Function Index (FSFI) is a 19-item questionnaire that can be administered in any age group and focuses on individual function via six domains: desire, arousal, lubrication, orgasm, satisfaction and pain.

  • Urogenital Distress Inventory (UDI-6) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    The Urogenital Distress Inventory-6 (UDI-6) is a 6-question instrument about lower urinary tract symptoms separated into 3 scales: irritative symptoms, obstructive/discomfort symptoms and stress symptoms. Respondents rate the degree to which each is bothersome on a 4-point scale.

  • Incontinence Impact Questionnaire-7 (IIQ-7) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    The Incontinence Impact Questionnaire-7 (IIQ-7) is a 7 item companion to the UDI-6 with condition-specific quality of life questions assessing the degree to which lower urinary tract symptoms affect daily activities via 4 scales: travel, social, emotional and physical.

  • Vaginal Electromyography (EMG) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ] [ Designated as safety issue: No ]
    Vaginal EMG readings will be completed by all participants at baseline (week 2 visit) and completion (week 12 visit); these electrodes are inserted vaginally and readings are recorded in μV to determine pelvic floor tone for correlation with ARM in order to determine if differences in primary and secondary outcomes for both groups are due to the BT/PT intervention.


Estimated Enrollment: 65
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physical Therapy (PT) and Behavioral Therapy (BT) Group

Intervention Group:

  1. Baseline Data obtained at 2-week visit

    • Demographic Data recorded
    • General Physical Exam findings recorded
    • Behavioral Therapy (BT) handouts given
    • Functional questionnaires administered in person (FIQOL, FISI, SF-12, FSFI, UDI-6, IIQ-7)
    • Physiologic measurements obtained (Vaginal EMG, Anal-rectal manometry)
    • Randomized to Physical Therapy (PT)
  2. Follow-up Evaluation at 6-week visit

    • PT session #1
    • Functional questionnaires administered in person
  3. Follow-up Evaluation at 8-week visit

    - PT session #2

  4. Follow-up Evaluation at 10-week visit

    - PT session #3

  5. Study Completion Visit at 12-week visit

    • Functional questionnaires administered in person
    • Final PT session #4
    • Final physiologic measurements obtained
    • Final Physical Exam findings recorded
  6. Long-term Follow-up at 24-weeks - Functional questionnaires administered by mail
Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT)
  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.
Other Name: Internal Pelvic Floor Physical Therapy
No Intervention: Control Group

Control Group:

  1. Baseline Data obtained at 2-week visit

    • Demographic Data recorded
    • General Physical Exam findings recorded
    • 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 and/or by mail

  3. Study Completion Visit at 12-week visit

    • Functional questionnaires administered in person
    • Final physiologic measurements obtained
    • Final Physical Exam findings recorded
  4. Long-term Follow-up at 24-weeks - Functional questionnaires administered by mail

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672697

Locations
United States, Ohio
TriHealth Hospitals
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
TriHealth Medical Education Research Fund (MERF)
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01672697     History of Changes
Other Study ID Numbers: 12005-TriHealth
Study First Received: August 21, 2012
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
anal incontinence
genital trauma
physical therapy
anal manometry

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014