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Title of the study:
The effect of different methods of drainage of the neuropathic bladder on the occurrence of symptomatic urinary infection, and adverse events related to the urinary drainage system in spinal cord injury patients - a prospective study
Patient Information Sheet
Urinary infection is one of the commonest ailments that may occur to people with spinal cord injury (SCI). As you may be aware, the common treatment options for the management of the (neuropathic) urinary bladder are as follow: (1) indwelling urethral catheter drainage; (2) suprapubic catheter drainage; (3) intermittent catheterisation; and (4) penile sheath drainage.
We are planning a research project to study symptomatic urinary infection in men with spinal cord injury.
How many patients will be recruited in this study?
Group 1 Male patients with indwelling urethral catheter 50
Group 2 Male patients who perform intermittent catheterisation
without wearing penile sheath 50
Group 3 Male patients performing intermittent catheterisation
and wearing penile sheath 50
Group 4 Male patients with penile sheath drainage 50
What are the objectives of this study?
What is the incidence of symptomatic urinary infection in persons with spinal cord injury who use different types of bladder drainage?
The secondary queries are:
(i) What are the predisposing factors for the occurrence of symptomatic urinary infection in persons with spinal cord injury?
(ii) What is the incidence of catheter and urinary drainage system-related adverse events in persons with spinal cord injury using different types of bladder drainage? E.g. indwelling urethral catheter drainage, intermittent urethral catheterisation, penile sheath drainage
What is the duration of the study?
Each participant will be observed for a period of 36 months from the date of enrolment.
Who can participate in this study?
1. Male patients with neuropathic bladder due to spinal cord injury
2. Patients 18 years or above
3. Patients who are willing to give informed consent for participation in the study
4. Patients who are registered with the Regional Spinal Injuries Centre, Southport
5. Patients who are willing to be followed-up for a period of 36 months from the date of enrolment. This will involve fortnightly telephonic contact with the spinal unit and attendance in the spinal unit whenever patients develop symptomatic urinary infection.
6. Patients who are willing to maintain record of adverse events related to urinary catheter and urinary drainage system.
How will this research project benefit me?
This study will provide information regarding
· Occurrence of urinary infection with different types of bladder drainage,
· Possible predisposing factors for the development of symptomatic urinary infection
· Adverse events related to different types of urinary drainage system.
Who else will know that I am participating in this study?
· It will be desirable to inform your General Practitioner that you are participating in this study. Will this be all right with you?
· Sometimes, it may be advantageous to let your District Nurse or your carer know that you are participating in this project. Would you like to speak to your carer and district nurse, or do you wish that we should send a copy of this information sheet to your district nurse and carer?
Is this study likely to cause discomfort or distress?
· No. There will be no physical discomfort or distress. When any participant develops urinary infection, he will come to the spinal unit, if the clinical condition permits. Blood and urine tests will be performed to confirm the diagnosis of acute urinary infection. Patients with acute urinary infection will be prescribed antibiotics as per the current clinical practice. No new treatment is being investigated in this study. All participants will continue to receive appropriate investigations and treatment for acute urinary infection as per the currently accepted clinical practice.
If I decide to participate in this study, what do I do?
Participation in this study entails keeping a diary over a period of 36 months and fortnightly telephonic contact with the spinal unit regarding
· Occurrence of symptomatic urinary infection,
· Possible predisposing factors for the occurrence of symptomatic urinary infection
· Adverse events related to urinary drainage system
Your confidentiality will be maintained at all times.
If I go on holidays, what will happen?
When you come back, we shall contact you by phone and then obtain the information from you for the period you were away. We shall appreciate if you can let us know whether you developed urinary infection, or any adverse event related to urinary drainage system while you were on holidays.
Do I have to make telephone calls every fortnight?
No. A doctor or a staff member from the spinal unit will ring you and speak to you on a pre-specified day and time to save inconvenience to you.
Can you tell me more details about this study?
· At the time of enrolment, the method of bladder drainage, and drugs taken in relation to bladder management, if any, will be noted.
· You will be given information sheets listing
(1) Signs and symptoms of urinary infection in patients with spinal cord injury and neuropathic urinary bladder
(2) Possible predisposing factors for the occurrence of urinary infection, and
(3) Possible adverse events related to urinary drainage system.
· You will maintain a diary to record whether you developed urinary infection, or any of the adverse events related to urinary drainage system.
· A nurse or a doctor will contact you once a fortnight by telephone. He/she will ring you on a pre-specified day and time to save inconvenience to you. He/she will ask you and/or your carer whether you developed any complication related to urinary drainage system during the preceding two weeks.
· You will contact the spinal unit whenever you think you have developed urinary infection. If you develop urinary infection and contact the spinal unit, a doctor or a nurse will speak to you and ask you to describe your overall condition.
The procedure will be as follows:
· If you are not very seriously ill and you are able to come to the spinal unit, you will be examined by one of the doctors associated with this study on arrival at the spinal unit.
· A sample of urine will be sent for microbiology. A blood sample will be taken for full blood count, kidney function and C-reactive protein to assess the degree of infection. The doctor may give you a prescription for a course of antibiotics if your condition requires that you should start taking antibiotics immediately.
· After you have gone home, a doctor or a nurse will speak to you over the phone on the next day and subsequently to inform you the results of urine and blood tests, and to ensure that you are making satisfactory recovery.
· If you are ill and require admission to a hospital, you will be admitted to the spinal unit if a bed is available.
· When you or your carer contacts the spinal unit to say that you are seriously ill with suspected urinary infection, you or your carer will be advised to contact your GP on call or go to the nearest A&E as in the normal course of events.
· If your General Practitioner decides to send you to a local hospital because you are very ill, a doctor or a nurse from the spinal unit who is involved in this study will contact the local hospital where you have been admitted. If a bed is available in the spinal unit, you will then be transferred to the spinal unit in Southport.
Can I refuse to participate in this study?
· Of course, the answer is YES.
· We wish to emphasise that your participation in this study is voluntary. You may choose not to take part in the study. Your decision will be respected.
· We assure you that if you do not wish to join the study, such a decision will not affect in any way your present or future treatment in the Spinal Unit.
Can I withdraw from the study?
You are free to withdraw from the study
· at any time without having to give a reason for withdrawing,
· and without affecting your future medical care in the Spinal Unit
If I develop urinary infection whom should I contact in the spinal unit?
You can ring the hospital (01704 547471) between 0900 hours and 1800 hours on weekdays and ask for extension 4354 or 4575. During the weekend, you can contact the spinal unit (extension 4346). If you are very ill, you should contact your GP as soon as possible or go to the nearest A&E, and then inform the spinal unit.
Who is the senior doctor overseeing this study?
Mr. Soni, Consultant in Spinal Injuries, Mr. Sett, Consultant in Spinal Injuries, and Mr. G. Singh, Consultant Urological Surgeon, Southport and Ormskirk Hospitals NHS Trust will be overseeing this study. In addition to these consultants, Mr. K.F. Parsons, Consultant Urological Surgeon, Royal Liverpool University Hospitals, Liverpool has kindly agreed to act as a Consultant for this study.
If I have any general query, whom should I contact?
You can ring the Spinal Unit Reception (01704 547471 extension 4391) between 0900 and 1700 hours from Monday to Friday.
We thank you in anticipation.
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