None listed
Conditions
Brief summary
The study will examine the feasibility, usefulness and acceptability of using the anal plug Coloplast PERISTEEN amongst stroke survivors with persistent Intractable Faecal Incontinence (IFI) during the rehabilitation phase. Patients from Bentley rehabilitation hospital will be recruited to the study and their primary carer over a period twelve months. The use of the anal plug will be compared to the usual care during this phase using a number of validated tools. In addition, both patients and carers will be asked to participate by completing a pre and post satisfaction survey which will also include a quality of life measure.
Interventions
Randomised Controlled Trial whereby the study participants are randomised to one of two groups. Randomisation will occur at patient level at Bentley Hospital site. The experimental group will be provided with the use of the Coloplast PERISTEEN Registered trademark anal plug in addition to usual care and the comparison control group will receive the usual rehabilitation FI care provided by the rehabilitation unit (excluding the use of the anal plug). The sample population are stroke survivor pat
Randomised Controlled Trial whereby the study participants are randomised to one of two groups. Randomisation will occur at patient level at Bentley Hospital site. The experimental group will be provided with the use of the Coloplast PERISTEEN Registered trademark anal plug in addition to usual care and the comparison control group will receive the usual rehabilitation FI care provided by the rehabilitation unit (excluding the use of the anal plug). The sample population are stroke survivor patients who are receiving care in a rehabilitation unit. The sample population have intractable faecal incontinence (IFI). The anal plug will be inserted with assistance on day one from the nurse. The nurse will assist the primary caregiver in the use of the anal plug at that point in time. Nursing shifts are 12 hour shifts. The staff member responsible for the patient will check the plug at the commencement of each shift (two) per day and will complete the Bristol Stool chart (BSC) for that patient at each shift. BSC data will be collected over a two week period (14 days ). The Peristeen Anal Plug is inserted like a suppository due to compression of the foam by outer film which then dissolves once inside the rectum. The anal plug I easily removed after a maximum of 12 hours using the gauze string attached to the plug. For this study, the plugs will be inserted twice in 24 hour period ( 1 per 12 hours) for 14 days.
Sponsors
University of Notre Dame
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility criteria for the study is as follows: Ischemic or haemorrhagic stroke with clinical diagnosis using NIH stroke scale Adult (over 25 years) Persistent faecal incontinence as defined by Norton et al (2010) At least one week post stroke Both groups will have been assessed by the Continence Nurse Specialist as having already received an assessment from a clinician which includes an abdominal assessments and per rectal examination.
Exclusion criteria
Faecal impaction or constipation using modified ROME diagnostic criteria for functional constipation Incontinence caused by infective agent.
Outcome results
None listed