NCT05222217

Gatekeeper for Soiling and Gas Incontinence

Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Hospital Mutua de Terrassa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Faecal incontinence has a broad spectrum of symptoms. Some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. Although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined. The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before. Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses

Conditions

• Gas Incontinence
• Soilings, Fecal

Interventions

Type	Name	Description
DEVICE	Gatekeeper	Six polyacrylonitrile prostheses (THD Gatekeeper™ Delivery System, THD SpA, Correggio, Italy) were implanted under 3D-EUS control through a 5mm perianal incision at 1, 3, 5, 7, 9 and 11 o'clock in lithotomy position, and located in the upper-middle intersphincteric space of the anal canal, using a specifically designed system.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2022-02-03
• Last updated: 2022-02-03