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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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).
Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, Switzerland
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
Time frame: 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
Time frame: 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
Time frame: 32 weeks
Fecal Incontinence
Vaizey Score (Gut (1999) 44:77) * Fecal incontinence score similar to Wexner Score
Time frame: before treatment, 6, 12, 32 wks after initial treatment
Anorectal manometric measurements
compared to pre-treatment values
Time frame: 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
Time frame: before treatment, 6, 32 wks after initial treatment
Cost
total cost of treatment will be evaluated (material, work hours etc)
Time frame: at the end of the treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adverse Events
adverse events between treatments: * pain, bleeding, neurological sensation, other AE Adverse events during percutaneous nerve stimulation: * pain, bleeding and discomfort
Time frame: for each treatment interval
Urinary incontinence
Hanley Score (BMJ (2001) 322:1096) * Urinary incontinence score
Time frame: before treatment, 6, 12, 32 wks after initial treatment