Transdermal endoscopic sacral nerve stimulation - endoscopic parasacral nerve stimulation as treatment for fecal incontinence

Not Applicable

• Conditions: R15; Faecal incontinence

• Registration Number: DRKS00000238
• Lead Sponsor: niversitätsklinikum FreiburgAbteilung für Allgemein- und Viszeralchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

>18 years
-neurogenic fecal incontinence
-muscular fecal incontinence: only small lesion of the sphincter (max. 1/4 of circumference
-Anatomy of the os sacrum, that complicates or prohibits standard-SNS
-signed informed consent

Exclusion Criteria

-<18 years
-primary neurologic degenerative reason for fecal incontinence
-coagulopathy
-infectons like pneumonia, infection of the urinary tract, infection of soft tissue with danger of bacteriemia
-rectal surgery via abdominal access
-pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-positive peripheral nerve evaluation via electromyogram || -number of indications for permanent SNS || -clinical response to tSNS (temporare SNS): clinical and a significant subjective improvement for the patient (stool diary-score and Wexner-score)

Secondary Outcome Measures

Name	Time	Method
-number of complications || -duration of intervention || -improvement of anal compression (anal manometry) || -improvement of concomitant urinary incontinence