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Treatment of Anal Incontinence With Intersphincteric Implants

Primary Purpose

Anal Incontinence, Fecal Incontinence

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sphinkeeper
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Incontinence focused on measuring Sphinkeeper, Intersphincteric implants, Gatekeeper

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intersphincteric implants

Arm Description

Treatment with intersphincteric implants in the anal sphincter using Sphinkeeper

Outcomes

Primary Outcome Measures

Severity of anal incontinence
Reduction in St Marks score

Secondary Outcome Measures

Postoperative infection
Rate of infection i.e. formation of abcess within the first year of treatment.
Change from baseline in pain scores on the VAS at 3 and 12 months.
VAS (Visual Analog Scale)

Full Information

First Posted
March 6, 2017
Last Updated
January 17, 2022
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT03080753
Brief Title
Treatment of Anal Incontinence With Intersphincteric Implants
Official Title
Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Study halted due to lower success rates than expected, under evaluation, will potentially resume at a later date.
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Incontinence, Fecal Incontinence
Keywords
Sphinkeeper, Intersphincteric implants, Gatekeeper

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intersphincteric implants
Arm Type
Experimental
Arm Description
Treatment with intersphincteric implants in the anal sphincter using Sphinkeeper
Intervention Type
Device
Intervention Name(s)
Sphinkeeper
Other Intervention Name(s)
Gatekeeper, Intersphincteric implants
Intervention Description
Intersphincteric implants in the anal sphincter
Primary Outcome Measure Information:
Title
Severity of anal incontinence
Description
Reduction in St Marks score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Postoperative infection
Description
Rate of infection i.e. formation of abcess within the first year of treatment.
Time Frame
12 months
Title
Change from baseline in pain scores on the VAS at 3 and 12 months.
Description
VAS (Visual Analog Scale)
Time Frame
Baseline, 3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Subject must be at least 18 years of age Subject must have a St Marks score of at least 11 Subject must be able to comply with study and study follow-up requirements. Exclusion Criteria: Subjects with Crohn's disease or Ulcerative colitis Subject has (a history of) malignancy in the rectum or anal canal Subject has an ongoing treatment with chemotherapy (all indications) Subject has verified active anal fistula(e) Subject is unable or unwilling to provide informed consent.
Facility Information:
Facility Name
Skåne University Hospital
City
Malmo
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21928378
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.
Results Reference
background
PubMed Identifier
26621029
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.
Results Reference
background
PubMed Identifier
26658726
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.
Results Reference
background
PubMed Identifier
25460440
Citation
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.
Results Reference
background
PubMed Identifier
27050607
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.
Results Reference
background
PubMed Identifier
26299888
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.
Results Reference
background
PubMed Identifier
23450581
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.
Results Reference
background
PubMed Identifier
22786479
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.
Results Reference
background
PubMed Identifier
26365115
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.
Results Reference
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Treatment of Anal Incontinence With Intersphincteric Implants

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