Fecal Incontinence Clinical Trial
Official title:
Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)
Verified date | February 2024 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether treatment with intersphincteric implants is an effective and safe treatment option for patients with anal incontinence
Status | Terminated |
Enrollment | 10 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. 2. Subject must be at least 18 years of age 3. Subject must have a St Marks score of at least 11 4. Subject must be able to comply with study and study follow-up requirements. Exclusion Criteria: 1. Subjects with Crohn's disease or Ulcerative colitis 2. Subject has (a history of) malignancy in the rectum or anal canal 3. Subject has an ongoing treatment with chemotherapy (all indications) 4. Subject has verified active anal fistula(e) 5. Subject is unable or unwilling to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Sweden | Skåne University Hospital | Malmo |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Al-Ozaibi L, Kazim Y, Hazim W, Al-Mazroui A, Al-Badri F. The Gatekeeper for fecal incontinence: Another trial and error. Int J Surg Case Rep. 2014;5(12):936-8. doi: 10.1016/j.ijscr.2014.08.002. Epub 2014 Oct 12. — View Citation
Forte ML, Andrade KE, Lowry AC, Butler M, Bliss DZ, Kane RL. Systematic Review of Surgical Treatments for Fecal Incontinence. Dis Colon Rectum. 2016 May;59(5):443-69. doi: 10.1097/DCR.0000000000000594. — View Citation
Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD007959. doi: 10.1002/14651858.CD007959.pub3. — View Citation
Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD002111. doi: 10.1002/14651858.CD002111.pub3. — View Citation
Ratto C, Buntzen S, Aigner F, Altomare DF, Heydari A, Donisi L, Lundby L, Parello A. Multicentre observational study of the Gatekeeper for faecal incontinence. Br J Surg. 2016 Feb;103(3):290-9. doi: 10.1002/bjs.10050. Epub 2015 Dec 1. — View Citation
Ratto C, Donisi L, Litta F, Campenni P, Parello A. Implantation of SphinKeeper(TM): a new artificial anal sphincter. Tech Coloproctol. 2016 Jan;20(1):59-66. doi: 10.1007/s10151-015-1396-0. Epub 2015 Dec 12. — View Citation
Ratto C, Parello A, Donisi L, Litta F, De Simone V, Spazzafumo L, Giordano P. Novel bulking agent for faecal incontinence. Br J Surg. 2011 Nov;98(11):1644-52. doi: 10.1002/bjs.7699. Epub 2011 Sep 16. — View Citation
Thaha MA, Abukar AA, Thin NN, Ramsanahie A, Knowles CH. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. 2015 Aug 24;2015(8):CD004464. doi: 10.1002/14651858.CD004464.pub3. — View Citation
Wang MH, Zhou Y, Zhao S, Luo Y. Challenges faced in the clinical application of artificial anal sphincters. J Zhejiang Univ Sci B. 2015 Sep;16(9):733-42. doi: 10.1631/jzus.B1400242. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of anal incontinence | Reduction in St Marks score | 12 months | |
Secondary | Postoperative infection | Rate of infection i.e. formation of abcess within the first year of treatment. | 12 months | |
Secondary | Change from baseline in pain scores on the VAS at 3 and 12 months. | VAS (Visual Analog Scale) | Baseline, 3 months and 12 months |
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