Anal IncontinenceNCT03080753
Treatment of Anal Incontinence With Intersphincteric Implants
A study testing Sphinkeeper in people with Anal Incontinence and Fecal Incontinence, run by Region Skane at 1 site in Sweden.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Incontinence, Fecal Incontinence
- What is being tested?
- Sphinkeeper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 11 Oct 2017to 1 Oct 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)
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
Read the 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.
- Conditions
- Anal Incontinence, Fecal Incontinence
- Being tested
- Sphinkeeper
- Keywords
- Sphinkeeper, Intersphincteric implants, Gatekeeper
- Medical subject headings
- Encopresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SphinkeeperDevice
Also called Gatekeeper, Intersphincteric implants
Intersphincteric implants in the anal sphincter
| Study group | Role | What they receive |
|---|---|---|
| Intersphincteric implants | Experimental | Treatment with intersphincteric implants in the anal sphincter using Sphinkeeper Receives: Device: Sphinkeeper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of anal incontinence
Reduction in St Marks score
Measured: 12 months
Secondary outcomes (2)
Postoperative infection
Rate of infection i.e. formation of abcess within the first year of treatment.
Measured: 12 months
Change from baseline in pain scores on the VAS at 3 and 12 months.
VAS (Visual Analog Scale)
Measured: Baseline, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start11 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: Study halted due to lower success rates than expected, after evaluation we have decided not to resume the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080753
- Sponsor's protocol ID
- Sphinkeeper 2017
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2017
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21928378Ratto 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.
PubMed 26621029Ratto 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.
PubMed 26658726Al-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.
PubMed 25460440Forte 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.
PubMed 27050607Thaha 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.
PubMed 26299888Maeda 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.
PubMed 23450581Norton 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.
PubMed 22786479Wang 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.
PubMed 26365115