Trial Outcomes & Findings for The Role of Biofeedback in Improving Continence After Anterior Resection (NCT NCT00515853)

NCT ID: NCT00515853

Last Updated: 2022-03-07

Results Overview

The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 121 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-03-07

Participant Flow

Participant milestones

Measure	Biofeedback Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises	No Biofeedback Did not received feedback
Overall Study STARTED	61	60
Overall Study COMPLETED	46	43
Overall Study NOT COMPLETED	15	17

Reasons for withdrawal

Measure	Biofeedback Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises	No Biofeedback Did not received feedback
Overall Study Lost to Follow-up	9	13
Overall Study Withdrawal by Subject	6	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Biofeedback n=61 Participants Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises	No Biofeedback n=60 Participants Did not received feedback	Total n=121 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 10 • n=61 Participants	66 years STANDARD_DEVIATION 9 • n=60 Participants	67 years STANDARD_DEVIATION 10 • n=121 Participants
Sex: Female, Male Female	23 Participants n=61 Participants	27 Participants n=60 Participants	50 Participants n=121 Participants
Sex: Female, Male Male	38 Participants n=61 Participants	33 Participants n=60 Participants	71 Participants n=121 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	61 participants n=61 Participants	60 participants n=60 Participants	121 participants n=121 Participants
Incontinence (CCI) score	4 scores on a scale STANDARD_DEVIATION 5 • n=61 Participants	4 scores on a scale STANDARD_DEVIATION 5 • n=60 Participants	4 scores on a scale STANDARD_DEVIATION 5 • n=121 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Analyzed participants, less than the randomized participants

The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.

Outcome measures

Measure	Biofeedback n=43 Participants Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises	No Biofeedback n=46 Participants Did not received feedback
Cleveland Clinic Incontinence (CCI) Score Adjusted CCI final	1.2 score on a scale Standard Deviation 6.0	-0.7 score on a scale Standard Deviation 5.5
Cleveland Clinic Incontinence (CCI) Score CCI final	4.2 score on a scale Standard Deviation 4.2	3.7 score on a scale Standard Deviation 3.5

Adverse Events

Biofeedback

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

No Biofeedback

Serious events: 7 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Biofeedback n=61 participants at risk Received feedback Biofeedback: Biofeedback sessions or biofeedback exercises	No Biofeedback n=60 participants at risk Did not received feedback
Surgical and medical procedures Abdominoperineal excision	3.3% 2/61 • Number of events 2 • 1 year	3.3% 2/60 • Number of events 2 • 1 year
Surgical and medical procedures Hartman procedures	4.9% 3/61 • Number of events 3 • 1 year	6.7% 4/60 • Number of events 4 • 1 year
Gastrointestinal disorders Rectovaginal fistula	0.00% 0/61 • 1 year	1.7% 1/60 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Sophie A. Pilkington

University of Southampton

Phone: +44 (0)23 8059 5058

Email: rgioinfo@soton.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place