Protocol of a prospective cohort study of the effect of different methods of drainage of neuropathic bladder on occurrence of symptomatic urinary infection, and adverse events related to the urinary drainage system in spinal cord injury patients.
BACKGROUND
To 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).


OBJECTIVE
(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?


METHODS
The 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.


METHODS
The 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.


CONCLUSIONS
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 SCI patients using different methods of bladder drainage.
Vaidyanathan
S
S
Regional Spinal Injuries Centre, District General Hospital, Southport PR8 6PN, UK. vaidyanathansiu@hotmail.com
Soni
B M
BM
Gurpreet
S
S
Mansour
P
P
Hughes
P L
PL
Oo
T
T
Sett
P
P
Parsons
K F
KF
Davies
J C
JC
D000328:Adult; D002985:Clinical Protocols; D015331:Cohort Studies; D004322:Drainage / Q000009:adverse effects* / Q000379:methods; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D013119:Spinal Cord Injuries / Q000150:complications*; D001750:Urinary Bladder, Neurogenic / Q000150:complications*; D014546:Urinary Catheterization / Q000009:adverse effects* / Q000379:methods; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000209:etiology*