Fecal IncontinenceNCT02989545
The Use of an "Anal-Tape" in Patients With Fecal Incontinence
A study testing Anal Tape in people with Fecal Incontinence, run by Shaare Zedek Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Anal Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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.
About this study
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.
- Conditions
- Fecal Incontinence
- Being tested
- Anal Tape
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal TapeDevice
| Study group | Role | What they receive |
|---|---|---|
| Off treatment | No intervention | 2 week period without intervention |
| Treatment period | Experimental | 2 week period with intervention Receives: Device: Anal Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (5)
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
Measured: 4 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Livovsky, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989545
- Sponsor's protocol ID
- Shaare Zedek Medical Center FI
- Status last verified
- Apr 2020
- First submitted
- 7 Dec 2016
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Livovsky DM, Koslowsky B, Goldin E, Lysy J. External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study. Int Urogynecol J. 2022 Oct;33(10):2859-2868. doi: 10.1007/s00192-021-05050-z. Epub 2022 Jan 18.
PubMed 35039916
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an "Anal-Tape" in Patients With Fecal Incontinence
- ClinicalTrials.gov ID
- NCT02989545
- Acronym / sponsor ID
- Shaare Zedek Medical Center FI
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off treatment | No intervention | –2 week period without intervention |
| Treatment period | Experimental | Device: Anal Tape2 week period with intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal Tape | Device | Treatment period |
Primary outcome
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
Time frame: 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.
5 secondary outcomes
A 50% Reduction in the Number of Episodes of FI Per Week
Time frame: 4 weeks
Mean Wexner Score
Time frame: 2 weeks
Mean Redction in Wexner Scale Compared to Baseline
Time frame: 2 weeks
General Satisfaction
Time frame: 2 weeks
Willingness of the Patient to Continue Using the Anal Tape After the Study.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35039916Livovsky DM, Koslowsky B, Goldin E, Lysy J. External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study. Int Urogynecol J. 2022 Oct;33(10):2859-2868. doi: 10.1007/s00192-021-05050-z. Epub 2022 Jan 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Anal Tape in people with Fecal Incontinence, run by Shaare Zedek Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.