Status:
COMPLETED
Optimising Treatments for Faecal Incontinence
Lead Sponsor:
London North West Healthcare NHS Trust
Conditions:
Faecal Incontinence
Pelvic Floor Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to directly compare two medical treatments for faecal incontinence: Renew™ Anal Insert and Percutaneous Tibial Nerve Stimulation (PTNS) for a period of 12 weeks. Both are r...
Detailed Description
The Renew™ anal insert is a new single-use anal device, CE marked and widely used in the UK and Europe. It is indicated for the management of faecal incontinence and designed to seal and prevent the i...
Eligibility Criteria
Inclusion
- Passive or mixed faecal incontinence.
- Minimum two or more episodes of faecal incontinence per week as assessed by prospectively collected bowel diaries.
- Failed biofeedback, pelvic floor physiotherapy or other medical management.
- Able to self- administer the Renew™ Anal Insert.
- Competent and willing to fill in questionnaires and attend clinics throughout the study.
- Patient must be able to comprehend and informed consent prior to enrolment in the study.
Exclusion
- Pregnancy.
- Inability to given informed consent.
- Perianal sepsis.
- Rectal bleeding.
- Inflammatory bowel disease/ Proctitis.
- Rectal prolapse.
- Third or fourth-degree hemorrhoids.
- Anal stricture.
- Anal or Recto-vaginal fistula.
- Rectal surgery in the past 3 months.
- Known allergy to Silicone.
- Patients who are mentally or physically unable to comply with the protocol of the study.
- The presence of any other medical condition which, in the opinion of the Chief Investigator, deems the patient unsuitable for participation in the study.
Key Trial Info
Start Date :
December 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04273009
Start Date
December 15 2016
End Date
September 11 2018
Last Update
February 17 2020
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