Trial Outcomes & Findings for Treatment of Patients With Fecal Incontinence (NCT NCT00292318)
NCT ID: NCT00292318
Last Updated: 2015-08-19
Results Overview
Only reporting the results of participants who reported adequate relief.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.
Results posted on
2015-08-19
Participant Flow
Participant milestones
| Measure |
Control
Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises.
|
Study Grp/Biofeedback
Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Control
Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises.
|
Study Grp/Biofeedback
Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
|
|---|---|---|
|
Overall Study
Study terminated by officials
|
2
|
1
|
Baseline Characteristics
Treatment of Patients With Fecal Incontinence
Baseline characteristics by cohort
| Measure |
Control
n=4 Participants
Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises.
|
Study Grp/Biofeedback
n=3 Participants
Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.Population: Only participants that completed the full number of study visits were analyzed.
Only reporting the results of participants who reported adequate relief.
Outcome measures
| Measure |
Control
n=2 Participants
Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
control group: Medical counseling and ano-sphinctal exercises.
|
Study Grp/Biofeedback
n=2 Participants
Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
|
|---|---|---|
|
Patient Report of "Adequate Relief" From FI Symptoms With a "Yes" Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A "Responder" Will be Defined as One Who Provides a "Yes" Answer.
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.Population: Data were not collected due medical instruments to measure this outcome were removed by VA staff causing the study to be terminated.
Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Grp/Biofeedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Felix W. Leung, MD
Greater Los Angeles VA Medical Center
Phone: 818-891-7711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place