Anal Sphinkeeper in patients with faecal incontinence: a multicentre prospective evaluation in the UK

Anal Sphinkeeper in patients with faecal incontinence: a multicentre prospective evaluation of surgical outcomes and faecal incontinence following Sphinkeeper application for patients with faecal incontinence

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN61603070

Enrollment

Registered

2018-11-15

Start date

2018-11-01

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Faecal incontinence Digestive System Faecal incontinence

Interventions

Patients participating in this study will be seen in the outpatient department before to discuss Sphinkeeper surgery. During this visit patients will have a full faecal incontinence history, past obst

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients receiving Sphinkeeper surgery for faecal incontinence

Exclusion criteria

Exclusion criteria: Patients unable to give consent

Design outcomes

Primary

Measure	Time frame
Faecal incontinence, assessed using the following at baseline and at 6- and 12-months post-operatively: 1. Vaizey/St Mark's score 2. Faecal incontinence quality of life score	—

Secondary

Measure	Time frame
1. Post-operative complications such as peri-prosthetic abscess or anal fistula measured in the immediate post-operative period (1-30 days post-operatively) 2. The correct distribution of the implants measured by endoanal ultrasonography intra-operatively, in the immediate post-operative period and at 6 and 12 months post-op 3. Anorectal physiology with rest and squeeze pressures recorded pre-operatively and at 6 and 12 months post-op	—

Measure

Time frame

1. Post-operative complications such as peri-prosthetic abscess or anal fistula measured in the immediate post-operative period (1-30 days post-operatively) 2. The correct distribution of the implants measured by endoanal ultrasonography intra-operatively, in the immediate post-operative period and at 6 and 12 months post-op 3. Anorectal physiology with rest and squeeze pressures recorded pre-operatively and at 6 and 12 months post-op

—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactAndrew Clarke

andrew.clarke@uhd.nhs.uk+44 (0)1202665511

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026