Fecal Incontinence
Conditions
Keywords
Fecal Incontinence, Fecal Urge Incontinence, Percutaneous tibial nerve stimulation
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.
Interventions
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).
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Incontinence | 6 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fecal Incontinence | before treatment, 6, 12, 32 wks after initial treatment | Vaizey Score (Gut (1999) 44:77) * Fecal incontinence score similar to Wexner Score |
| 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) |
Countries
Switzerland
Outcome results
None listed