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The Use of an "Anal-Tape" in Patients With Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT02989545
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dan Livovsky, Shaare Zedek Medical Center

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.


Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: Anal Tape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
No Intervention: Off treatment
2 week period without intervention
Experimental: Treatment period
2 week period with intervention
Device: Anal Tape



Primary Outcome Measures :
  1. Improvement of at least 5 point in the in the quality of life questionnaire [ Time Frame: 4 weeks ]
  2. A 50% reduction in the number of episodes of FI or days per week, evaluated with the bowel diary and the weekly Wexner questionnaire. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Any improvement in Wexner score, both total score and any of its components. [ Time Frame: 4 weeks ]
  2. Any improvement in quality of life score, and in any of its component [ Time Frame: 4 weeks ]
  3. Usability score [ Time Frame: 4 weeks ]
  4. General satisfaction using a VAS score. [ Time Frame: 4 weeks ]
  5. Willingness of the patient to continue using the anal tape after the study. [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Dan Livovsky, Dr. Dan M. Livovsky and Dr. Joseph Lysy, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02989545     History of Changes
Other Study ID Numbers: Shaare Zedek Medical Center FI
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases