NCT03080753

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

March 6, 2017

Last Update Submit

February 29, 2024

Conditions

Anal IncontinenceFecal Incontinence

Keywords

SphinkeeperIntersphincteric implantsGatekeeper

Outcome Measures

Primary Outcomes (1)

  • Severity of anal incontinence

    Reduction in St Marks score

    12 months

Secondary Outcomes (2)

  • Postoperative infection

    12 months

  • Change from baseline in pain scores on the VAS at 3 and 12 months.

    Baseline, 3 months and 12 months

Study Arms (1)

Intersphincteric implants

EXPERIMENTAL

Treatment with intersphincteric implants in the anal sphincter using Sphinkeeper

Device: Sphinkeeper

Interventions

SphinkeeperDEVICE

Intersphincteric implants in the anal sphincter

Also known as: Gatekeeper, Intersphincteric implants
Intersphincteric implants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

Location

Related Publications (9)

  • 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.

    PMID: 21928378BACKGROUND

  • 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.

    PMID: 26621029BACKGROUND

  • 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.

    PMID: 26658726BACKGROUND

  • 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.

    PMID: 25460440BACKGROUND

  • 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.

    PMID: 27050607BACKGROUND

  • 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.

    PMID: 26299888BACKGROUND

  • Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD007959. doi: 10.1002/14651858.CD007959.pub3.

    PMID: 23450581BACKGROUND

  • Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD002111. doi: 10.1002/14651858.CD002111.pub3.

    PMID: 22786479BACKGROUND

  • 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.

    PMID: 26365115BACKGROUND

MeSH Terms

Conditions

EncopresisFecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental DisordersRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 15, 2017

Study Start

October 11, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)