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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pTNS treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous tibial nerve stimulation (pTNS) | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Incontinence | Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment
| 6 weeks |
| Fecal Incontinence | Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment
| 12 weeks |
| Fecal Incontinence | Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment
| 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal Incontinence | Vaizey Score (Gut (1999) 44:77)
| before treatment, 6, 12, 32 wks after initial treatment |
| Anorectal manometric measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas T Marti, Dr. med. | Department of Surgery, Cantonal Hospital St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Cantonal Hospital St. Gallen | Sankt Gallen | 9007 | Switzerland |
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| Label | URL |
|---|---|
| Website of the Department of Surgery, Cantonal Hospital of St. Gallen (German only) | View source |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
|
compared to pre-treatment values
| 12 weeks |
| Quality of Life | 2 scores for quality of life are measured:
| 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:
Adverse events during percutaneous nerve stimulation:
| for each treatment interval |
| Urinary incontinence | Hanley Score (BMJ (2001) 322:1096)
| before treatment, 6, 12, 32 wks after initial treatment |