Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: Percutaneous tibial nerve stimulation (pTNS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pTNS treatment<br> | Procedure: Percutaneous tibial nerve stimulation (pTNS)<br>* A 34 gauge needle in placed close to the tibial nerve about 2-3 cm above the ankle. A self-adhesive surface electrode is placed on the skin. Needle and surface electrode are connected to an electric stimulator and the stimulating current (0 - 10 mA) is increased in 20 steps. When the patient feels a tingling sensation in the foot, stimulating current is set back for one step and the treatment is started (30 min stimulation).<br>* Other names: peripheral neuromodulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Incontinence | 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 | 6 weeks | 
| Fecal Incontinence | 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 | 12 weeks | 
| Fecal Incontinence | 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 | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Incontinence | Vaizey Score (Gut (1999) 44:77) Fecal incontinence score similar to Wexner Score | before treatment, 6, 12, 32 wks after initial treatment | 
| Anorectal manometric measurements | compared to pre-treatment values | 12 weeks | 
| Quality of Life | 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 | before treatment, 6, 32 wks after initial treatment | 
| Cost | total cost of treatment will be evaluated (material, work hours etc) | at the end of the treatment | 
| Adverse Events | adverse events between treatments: pain, bleeding, neurological sensation, other AE Adverse events during percutaneous nerve stimulation: pain, bleeding and discomfort | for each treatment interval | 
| Urinary incontinence | Hanley Score (BMJ (2001) 322:1096) Urinary incontinence score | before treatment, 6, 12, 32 wks after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Incontinence, Fecal Urge Incontinence, Percutaneous tibial nerve stimulation