Trials / Completed
CompletedNCT02989545
The Use of an "Anal-Tape" in Patients With Fecal Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Shaare Zedek Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Anal Tape |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2016-12-12
- Last updated
- 2020-04-02
- Results posted
- 2020-04-02
Source: ClinicalTrials.gov record NCT02989545. Inclusion in this directory is not an endorsement.