Fecal Incontinence
Conditions
Brief summary
Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated. The prevalence of FI is probably underestimated in most studies. Currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy. The investigators developed an anal tape using a commercially available elastic band with a special adhesive that is approved for use in the skin. A special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter. This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with FI. The primary endpoint will be improvement in quality of life.
Interventions
DEVICEAnal Tape
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old * Fecal incontinence for more than 6 months * Willing to participate * Understand the study procedures * Is able to apply and remove the anal tape without significant assistance of others. * Have done sigmoidsocopy or colonoscopy and anal manometry within five year of screening visit
Exclusion criteria
* Advanced full thickness rectal prolapse. * Injured, inflamed or any significant disease in the peri-anal skin. * Allergy to any component of the device, either known or developed during testing in the screening visit. * Moderate to severe proctitis of any etiology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | 2 weeks | The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 excellent to 5 poor and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 extremely so to 6 not at all. The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A 50% Reduction in the Number of Episodes of FI Per Week | 4 weeks | Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study |
| Mean Wexner Score | 2 weeks | The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince. |
| Mean Redction in Wexner Scale Compared to Baseline | 2 weeks | The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince. |
| General Satisfaction | 2 weeks | General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction. |
| Willingness of the Patient to Continue Using the Anal Tape After the Study. | 4 weeks | Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients 2 week period without intervention then 2 week period with anal tape intervention | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 64 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 excellent to 5 poor and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 extremely so to 6 not at all. The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Off Treatment | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Lifestyle | 2.8 score on a scale | Standard Deviation 0.69 |
| Off Treatment | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Coping/Behaivoir | 1.9 score on a scale | Standard Deviation 0.64 |
| Off Treatment | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Depression/Self-Perception | 3.1 score on a scale | Standard Deviation 0.75 |
| Off Treatment | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Embarrassment | 2.13 score on a scale | Standard Deviation 0.67 |
| Treatment Period | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Embarrassment | 2.65 score on a scale | Standard Deviation 0.76 |
| Treatment Period | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Lifestyle | 3.3 score on a scale | Standard Deviation 0.68 |
| Treatment Period | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Depression/Self-Perception | 3.5 score on a scale | Standard Deviation 0.74 |
| Treatment Period | Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) | Coping/Behaivoir | 2.5 score on a scale | Standard Deviation 0.73 |
Secondary
A 50% Reduction in the Number of Episodes of FI Per Week
Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study
Time frame: 4 weeks
Population: Note that this outcome was obtained by free text stool diaries that patients had to keep at home. Only 15 patient out of 20 provided full diaries, therefore the analysis is limited to 15 instead of all 20.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Off Treatment | A 50% Reduction in the Number of Episodes of FI Per Week | 0 Participants |
| Treatment Period | A 50% Reduction in the Number of Episodes of FI Per Week | 5 Participants |
Secondary
General Satisfaction
General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.
Time frame: 2 weeks
Population: Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Off Treatment | General Satisfaction | 80 mm in VAS scale |
Secondary
Mean Redction in Wexner Scale Compared to Baseline
The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off Treatment | Mean Redction in Wexner Scale Compared to Baseline | 0.6 score on a scale | Standard Deviation 1.7 |
| Treatment Period | Mean Redction in Wexner Scale Compared to Baseline | 1.95 score on a scale | Standard Deviation 4.2 |
Secondary
Mean Wexner Score
The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off Treatment | Mean Wexner Score | 11.9 score on a scale | Standard Deviation 3.5 |
| Treatment Period | Mean Wexner Score | 10.3 score on a scale | Standard Deviation 4.8 |
Secondary
Willingness of the Patient to Continue Using the Anal Tape After the Study.
Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.
Time frame: 4 weeks
Population: Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Off Treatment | Willingness of the Patient to Continue Using the Anal Tape After the Study. | 90 mm in VAS scale |