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

NCT02989545 | Completed Results

• 1 other identifier: Shaare Zedek Medical Center FI
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (5)

• A 50% Reduction in the Number of Episodes of FI Per Week

  4 weeks

• Mean Wexner Score

  2 weeks

• Mean Redction in Wexner Scale Compared to Baseline

  2 weeks

• General Satisfaction

  2 weeks

• Willingness of the Patient to Continue Using the Anal Tape After the Study.

  4 weeks

Study Arms (2)

Off treatment

NO INTERVENTION

2 week period without intervention

Treatment period

EXPERIMENTAL

2 week period with intervention

Device: Anal Tape

Interventions

Anal Tape DEVICE

Treatment period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Related Publications (1)

• 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.

  PMID: 35039916 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Short term, single center, open label

Results Point of Contact

• Title: Dr. Dan Livovsky
• Organization: Shaare Zedek Medical Center

danlivo@szmc.org.il

+972525622398

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dan M. Livovsky and Dr. Joseph Lysy

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 12, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 2, 2020
• Results First Posted: April 2, 2020

Record last verified: 2020-04