Physical Therapy for Women With Obstetric Trauma and Anal Incontinence
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|ClinicalTrials.gov Identifier: NCT01672697|
Recruitment Status : Active, not recruiting
First Posted : August 27, 2012
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sphincter Ani Incontinence Obstetric Trauma||Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: Physical & Behavioral Therapy Group
Intervention Group: Randomized to Physical Therapy (PT)
Behavioral: Physical Therapy (PT) and Behavioral Therapy (BT)
Other Name: Internal Pelvic Floor Physical Therapy
No Intervention: Control Group
- Fecal Incontinence Quality of Life (FIQOL) [ Time Frame: 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.
- Anal-rectal manometry (ARM) [ Time Frame: 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.
- Fecal Incontinence Severity Index (FISI) [ Time Frame: baseline (2-weeks post delivery) to completion (12-weeks post delivery) ]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) ]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) ]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) ]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) ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672697
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|Study Director:||Rachel Pauls, MD||TriHealth Inc.|