Do Prostheses of SphinkeeperTM Migrate After Operation?

Status Completed

Clinical Trial Summary

32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.

Clinical Trial Description

The SphinkeeperTM is a new surgical procedure in order to treat refractory fecal incontinence, which includes up to ten self-expandable prostheses. These get implanted into the intersphincteric space and due to constriction of the anal canal and better contractibility continence should be improved. Because this is a new technique, there is only limited data about its clinical efficacy. In this study, patients, aged 18-90 years, who met the inclusion criteria and have received a SphinkeeperTM operation, were enrolled. Functional outcomes and quality of life got measured by standard questionnaires before surgery and 1, 2, 3 and 6 months after surgery. Furthermore, in routine check ups patients received endoanal anorectal manometry for pressure measurement and endoanal ultrasound to determine the position of the prostheses. ;

Study Design

Related Conditions & MeSH terms

Fecal Incontinence

Clinical Trial Details

NCT number	NCT04992429
Study type	Observational
Source	Medical University of Vienna
Contact
Status	Completed
Phase
Start date	June 1, 2020
Completion date	June 18, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03825575` - Sacral Neuromodulation as Treatment for Fecal Incontinence	N/A
Completed	`NCT00605826` - A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence	N/A
Withdrawn	`NCT02208258` - Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.	N/A
Completed	`NCT01957969` - French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence	N/A
Completed	`NCT01939821` - A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Recruiting	`NCT00530933` - Tibial Nerve Stimulation for Faecal Incontinence	N/A
Completed	`NCT00565136` - Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms	Phase 1/Phase 2
Withdrawn	`NCT00522691` - Efficacy of Sacral Nerve Stimulation Before Definitive Implantation	N/A
Completed	`NCT00677508` - Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Completed	`NCT05032534` - Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence	N/A
Completed	`NCT05058326` - Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Completed	`NCT03746834` - NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation	Phase 4
Completed	`NCT00124904` - Biofeedback for Fecal Incontinence	N/A
Completed	`NCT03028636` - LIBERATE - PRO: Eclipse™ System Registry
Completed	`NCT04097288` - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	Phase 1
Completed	`NCT05621629` - Management of FI After Surgery of ARM
Withdrawn	`NCT04138602` - BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence	N/A
Completed	`NCT04478799` - Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience	N/A
Completed	`NCT03252951` - Physical Therapy for Anal Incontinence	N/A