Abstract
BackgroundTo present a protocol of a prospective, cohort study in which four groups of spinal cord injury (SCI) patients will participate. (Patients with indwelling urethral catheter; patients who perform intermittent catheterisation without wearing a penile sheath; patients who perform intermittent catheterisation and wear penile sheath as well; and patients with penile sheath drainage).Objectives(1) What is the incidence of symptomatic urinary infection in men with spinal cord injury who use different types of bladder drainage? (2) Which are predisposing factors for the occurrence of symptomatic urinary infection in men with spinal cord injury who practise different methods of bladder drainage? (3) What is the incidence of catheter and urinary drainage system-related adverse events in the four groups of SCI patients?PatientsThe criteria for inclusion are as follow: (1) Male patients with neuropathic bladder due to spinal cord injury, who are registered with the Regional Spinal Injuries Centre, Southport, England. (2) Age: 18 years or above. (3) Patients who are willing to give informed consent for participation in the study. (4) Patients willing to be contacted every two weeks by a staff of the spinal unit for 36 months. (5) Patients who are willing to maintain an accurate record of adverse events related to urinary catheter and urinary drainage system and predisposing factors for the occurrence of symptomatic urinary infection. (6) Patients, who are stabilised in a particular method of bladder drainage, and therefore, unlikely to make a permanent change in the method of bladder drainage (e.g. from penile sheath drainage to the use of long-term indwelling catheter) during a foreseeable future.MethodsThe participants will be observed for a period of 36 months. A staff of the spinal injuries unit will contact the participants by telephone every two weeks on a mutually agreed day and time. The information obtained during this standardised telephonic interview conducted once in two weeks will be entered in a database. When a participant develops symptom(s) suggestive of urinary infection, he will undergo urine and blood tests, and imaging studies of the urinary tract.ConclusionThis study will provide information regarding the occurrence of symptomatic urinary infection, predisposing factors for development of urinary infection, and adverse events related to urinary catheter and urinary drainage system in SCI patients using different methods of bladder drainage.
Highlights
Urinary infection is one of the commonest causes of morbidity in persons with spinal cord injury after they have recovered from the initial effects of trauma
This study will provide information regarding the occurrence of symptomatic urinary infection, predisposing factors for development of urinary infection, and adverse events related to urinary catheter and urinary drainage system in spinal cord injury (SCI) patients using different methods of bladder drainage
We describe below a protocol of a prospective, cohort study to find out the incidence of urinary infection, predisposing factors for the occurrence of symptomatic urinary infection, and adverse events related to urinary catheter and urinary drainage system in male spinal cord injury patients using different methods of bladder drainage
Summary
Data will be collected from each patient for a period of 36 months regarding the occurrence of symptomatic urinary infection, predisposing factors for the development of symptomatic urinary infection, and adverse events related to urinary catheter and urinary drainage system including the actual procedure of urethral catheterisation. The investigators will discuss with the spinal cord injury patients participating in this study and their carers that they should make an entry daily whether any adverse event related to urinary catheter occurred or not The patients or their carers will note in the diary any change in the method of bladder drainage. Communication with research subjects A staff member of the spinal unit will contact the participants over the phone once every two weeks on a day and time convenient to the participant which will be decided at the time of enrolment e.g. alternate Mondays at 1500 hours The participants, his carers/partner, and the community nursing staff will be advised to contact the spinal unit whenever a patient develops symptoms or signs to suggest urinary infection, adverse event related to urinary catheter and urinary drainage system, or the predisposing factors for the development of urinary infection. None of the authors hold any stocks or shares in an organisation that may in any way gain or lose financially from the publication of this protocol
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