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21 March 2013
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| [ Print-friendly version ] |
| Sacral nerve stimulation or anal bulking therapy for faecal incontinence - a comparative study |
| ISRCTN | ISRCTN00247992 |
| DOI | 10.1186/ISRCTN00247992 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Sacral nerve stimulation or anal bulking therapy for faecal incontinence - a comparative study |
| Scientific title | Sacral nerve stimulation vs anal bulking for faecal incontinence - a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | There is a difference in efficency between the treatments. |
| Lay summary |
Background and study aims
Faecal incontinence is a common disease with considerable reduction of quality of life. Sacral nerve stimulation (SNS) and anal bulking therapy (ABT) are two treatments that have been developed during the last 10 years and are now frequently used. No proper comparison has been made between the two. The aim of this study is to compares the two treatments. Who can participate? Adult persons with faecal incontinence. The person fills out an incontinence diary during 3 weeks. A minimum of two episodes of faecal incontinence per week is required for participation. People with specific concurrent diseases ( eg previous rectal resection, inflammatory bowel disease) cannot participate. What does the study involve? Participants are randomly allocated to one of two treatments (SNS or ABT). After the treatment (surgery) the patients are followed for one year. During this time they fill out incontinence diaries and a questionnaire that evaluates Quality of Life. Minor or major adverse events are recorded. What are the possible benefits and risks of participating? Both treatments are part of regular health care and the risks are minor. The aim of the study is just the comparison of two treatment. There is no actual benefit for the patient. He/she gets a treatment for faecal incontinence. Where is the study run from? Gothenburg and Uppsala, Sweden. Hopefully one or two additional centres in Sweden and/or Norway will take part. When is the study starting and how long is it expected to run for? The study will start during Spring 2013 and is scheduled to end in 2 to 3 years. Who is funding the study? HTA-center, Gothenburg and Sahgrenska University Hospital (Sweden) Who is the main contact? Dr Lars Börjesson lars.g.borjesson@vgregion.se |
| Ethics approval | Gothenburg University Research Ethics Committee, 04 December 2011, ref: 858-11 |
| Study design | Multicenter interventional randomised controlled trial |
| Countries of recruitment | Sweden |
| Disease/condition/study domain | Faecal incontinence in adults |
| Participants - inclusion criteria |
1. Patients with fecal incontinence with > or = 2 episodes of fecal incontinence/week.
2. > 18 years 3. Insufficient effect of conservative treatment (physiotherphy, diet, drugs). 4. At least one year duration of symptoms 5. At least one year after vaginal delivery 6. Ability to confirm informed consent |
| Participants - exclusion criteria |
1. Complete external sphincter defect (at least 90 degrees, whole length of the anal canal evaluated by physical examination of ultrasound).
2. Ongoing anorectal infection 3. Active inflammatory bowel disease 4. Anorectal implant. 5. Anorectal surgery within the last 12 months. 6. Mucosal prolaps (gr 3-4) 7. Rectal prolaps 8. Ongoing malignant disease 9. Ongoing immunosuppressive treatment 10. Treatment with warfarin 11. Rectal anastomosis 12. Neurologic disease (MS, ALS, Myelomeningocele etc.) 13. Previous pelvic radiotherphy 14. Ongoing anorectal pain 15. Included in other RCT 16. Pregnancy 17. Previously treated with any of the two alternatives in the study 18. Concurrent condition or disease that makes the person unsutable for the study according clinical jugement of the investigator (eg not likely to follow the study protocol). |
| Anticipated start date | 01/03/2013 |
| Anticipated end date | 01/03/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet [Swedish] |
| Target number of participants | 100 |
| Interventions |
Two interventional arms:
1. Sacral nerve stimulation 2. Anal bulking therapy |
| Primary outcome measure(s) | Responding (> 50% reduction of the number of fecal incontinence episodes compared to baseline) proportion after one year after randomisation. |
| Secondary outcome measure(s) |
1. Change in number of faecal incontinence episodes
2. Change in deferring time 3. Change in incontinence score 4. Change in Quality of Life 5. Adverse events |
| Sources of funding | Sahgrenska University Hospital (Sweden) |
| Trial website | |
| Publications | |
| Contact name | Dr Lars Börjesson |
| Address |
Sahlgrenska University Hospital
Department of Surgery |
| City/town | Gothenburg |
| Zip/Postcode | 416 85 |
| Country | Sweden |
| Sponsor | Sahlgrenska University Hospital (Sweden) |
| Address | Health Technology Assessment Center |
| City/town | Gothenburg |
| Zip/Postcode | 413 45 |
| Country | Sweden |
| hta-centrum@vgregion.se | |
| Sponsor website: | http://www.sahlgrenska.se/hta-centrum |
| Date applied | 05/12/2012 |
| Last edited | 10/01/2013 |
| Date ISRCTN assigned | 10/01/2013 |
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