Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Not Applicable

Completed

• Conditions: Fecal Incontinence
• Interventions: Procedure: Percutaneous tibial nerve stimulation (pTNS)

• Registration Number: NCT01162525
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und adverse events will be monitored in this observational study.

Detailed Description

Before treatment patients will have a proctological exam, a proctoscopy, endosonography and anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores (FIQL, VAS) will be recorded.

Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve stimulations (pTNS).

During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks incontinence scores are recorded. Additionally after the end of phase 1 quality of life is measured and an anorectal manometry is preformed.

Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with stimulations every 3 weeks Phase 4 consists of one stimulation in one month.

After phase 4 incontinence scores und quality of life are measured.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• fecal urge incontinence
• conservative treatment has been performed without success

Exclusion Criteria

• current anticoagulation treatment
• sphincter defects larger than 120°
• pregnancy
• pace maker
• implanted defibrillators
• severe heart disease
• existing neurological damages
• disposition for strong bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pTNS treatment	Percutaneous tibial nerve stimulation (pTNS)	-

Primary Outcome Measures

Name	Time	Method
Fecal Incontinence	32 weeks	Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment; * Score for fecal incontinence, with 5 items and score range of 0 - 20

Secondary Outcome Measures

Name	Time	Method
Adverse Events	for each treatment interval	adverse events between treatments: * pain, bleeding, neurological sensation, other AE; Adverse events during percutaneous nerve stimulation: * pain, bleeding and discomfort
Urinary incontinence	before treatment, 6, 12, 32 wks after initial treatment	Hanley Score (BMJ (2001) 322:1096); * Urinary incontinence score
Cost	at the end of the treatment	total cost of treatment will be evaluated (material, work hours etc)
Fecal Incontinence	before treatment, 6, 12, 32 wks after initial treatment	Vaizey Score (Gut (1999) 44:77); * Fecal incontinence score similar to Wexner Score
Anorectal manometric measurements	12 weeks	compared to pre-treatment values
Quality of Life	before treatment, 6, 32 wks after initial treatment	2 scores for quality of life are measured: * Fecal Incontinence Quality of Life (FIQL) (Dis Colon Rectum (2000) 43:9); * Visual Analogue Score Patients are asked to score their well-being in respect to the incontinence by marking a horizontal 10 cm line labelled "extremely bad" and "excellent" at both ends

Trial Locations

Locations (1)

Department of Surgery, Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, Switzerland