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Sacral nerve modulation (SNM) is an established treatment for refractory lower urinary tract and bowel dysfunction (Spinelli 2008). Pudendal nerve stimulation (PNS) has been proposed for patients failing SNM treatment of urinary dysfunction (Spinelli 2005). In this study SNM and PNS are compared for the treatment of fecal incontinence. In a test phase, both treatments will be applied for one week each in a randomized and blinded order (cross-over design). After the test phase the more successful treatment will be determined and applied permanently. If both treatments are equally sufficient, PNS will be chosen for permanent stimulation, since preliminary data indicate that PNS has a lower power consumption than SNM. Lower power consumption results in a longer lifetime of the stimulator, thus requiring less replacement surgeries.
Primary Surgery:
Test phase:
Secondary surgery:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacral nerve modulation first | Experimental | Sacral nerve modulation is applied before the pudendal nerve stimulation. There is no "wash-out" period (pause) between the two treatments. |
|
| Pudendal nerve stimulation first | Experimental | Pudendal nerve stimulation is applied before the sacral nerve modulation. There is no "wash-out" period (pause) between the two treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacral nerve modulation | Procedure | For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Power consumption of stimulator | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wexner Score (Jorge 1993) | 7, 14 days, 3, 6 & 12 months | |
| Incidence of surgical complications (adverse events) graded according to Dindo (2004) | 30 days | |
| Quality of Life (FIQL (Rockwood 2000)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Marti, MD | Dep. of Surgery, Cantonal Hospital St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgey, Cantonal Hospital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18336992 | Background | Spinelli M, Sievert KD. Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Eur Urol. 2008 Dec;54(6):1287-96. doi: 10.1016/j.eururo.2008.01.076. Epub 2008 Feb 8. | |
| 15977260 | Background | Spinelli M, Malaguti S, Giardiello G, Lazzeri M, Tarantola J, Van Den Hombergh U. A new minimally invasive procedure for pudendal nerve stimulation to treat neurogenic bladder: description of the method and preliminary data. Neurourol Urodyn. 2005;24(4):305-9. doi: 10.1002/nau.20118. |
| Label | URL |
|---|---|
| Proctological consultations, Department of Surgery | 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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| Pudendal nerve stimulation | Procedure | For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient. |
|
|
| 14 days, 3, 6 & 12 months |
| 8416784 | Background | Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307. |
| 10813117 | Background | Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |