Treatment of Anal Incontinence With Intersphincteric Implants

Fecal Incontinence Clinical Trial

Official title:

Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03080753
• Other study ID #: Sphinkeeper 2017
• Status: Terminated
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Treatment of anal incontinence (AI) remains a challenge - although conservative treatment can reduce the severity of many patients' AI, many continue to experience symptoms that severly affect their quality of life and ability to function properly both socially and professionally.

The level of AI is measured with the St Marks score (ranging from 0-24 where zero is complete continence).

Some patients with AI are shown to have defects in the anal sphincters (i.e. traumatic lesions post partum) and can be helped with reconstructive surgery. These procedures are effective but carry substantial risk for postoperative infection, and the healing process is painful.

One of the main treatment options for anal incontinence today is Sacral Nerve Stimulation (SNS), which is an effective but invasive and expensive treatment with a rather high level of infection. It is normally performed in two separate sessions and require life-long follow up and new surgical procedures every 6-7 years.

Historically artificial anal sphincters have been studied and shown to be effective but with high rates of infections leading to removal of the device. In more recent years studies have instead focused on "bulking agents" (injection of i.e. silicone in the submucosal space with the aim to increase the resting pressure of the anal canal), but the effect seems to be limited and the agents injected are rapidly resorbed by the body.

Treatment with intersphincteric implants is a novel treatment option for these patients. Available studies have shown good results regarding effect and a low frequence of postoperative infections. The implants rarely dislocate and are not resorbed by the body, which contributes to their long-term effectiveness. The operation is performed under a short general anaesthesia and in available studies the postoperative symptoms are few. The first technique described was called Gatekeeper (six implants), and this has since been completed by the Sphinkeeper (ten implants), which is the focus of the present study.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

Device:
• Sphinkeeper
Intersphincteric implants in the anal sphincter

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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

Outcome

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