Study protocol 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). 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? Patients: 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. Conclusion: 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. Published: 21 November 2001 BMC Urology 2001, 1:2 Received: 13 October 2001 Accepted: 21 November 2001 This article is available from: http://www.biomedcentral.com/1471-2490/1/2 © 2001 Vaidyanathan et al; licensee BioMed Central Ltd. Verbatim copying and redistribution of this article are permitted in any medium for any noncommercial purpose, provided this notice is preserved along with the article's original URL. For commercial use, contact [email protected] BMC Urology 2001, 1:2 http://www.biomedcentral.com/1471-2490/1/2 Introduction 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. A systematic review of risk factors for urinary tract infection in adults with spinal cord dysfunction showed that persons using intermittent catheterisation had fewer infections than those with indwelling catheters did [1]. A follow-up of 128 patients with spinal cord injury for a period of 38 months showed the number of episodes of urinary infection per 100 patients per day was 2.72 for males with indwelling catheters, and 0.41 for males who performed clean intermittent catheterisation [2]. Although intermittent catheterisation may be associated with fewer episodes of urinary infection, some patients may develop urethral stricture as a result of frequent urethral trauma [3]. A review of 21 patients who had been performing clean intermittent catheterisation for over five years (mean length of use: 9.5 years) showed a rate of urethral stricture of 19%, and of epididymitis of 28.5% [4]. A comparison of long-term renal function after spinal cord injury in 1114 persons who were injured between 1969 and 1994 showed that renal function was adequately preserved in the great majority of patients and did not appear to be influenced to any great extent by method of bladder management [5]. Therefore, it may seem reasonable when Yavuzer and associates [6] stated that the bladder management of spinal cord injury patients should be selected so as to be suitable to the patient's life style. Besides reducing morbidity, the method of bladder management should enhance the quality of life. We observed complications with intermittent catheterisation, some of which may be unusual in clinical practice [7]. Hair introduced during catheterisation may act as a nidus for stone formation in the urinary bladder [8]. We studied urethral cytology of 50 patients of neurogenic vesical dysfunction who were practising clean, intermittent catheterisation. The changes observed included increased numbers of squamous epithelial cells, irregularity of their cell margins, neutrophil stickiness to the cell margins, cytoplasmic vacuolation, nuclear pyknosis and karyorrhexis. Increased numbers of inflammatory cells and the presence of bacterial flora were also noted [9]. The degree of urethral inflammation was compared between patients practising intermittent catheterisation and those using long-term indwelling urethral catheters. Urethral cytology was taken and the smear was stained by Papanicolaou's method. The number of neutrophil polymorphs and epithelial cells in three random high power fields in the urethral smear was counted and the percentage ratio of polymorphs to epithelial cells was calculated. 17 patients were performing intermittent catheterisation with a single use LoFric catheter. Urethral cytology revealed a percentage (mean ratio) ratio of polymorphs to epithelial cells of 0.04. In contrast, the ratio of polymorphs to epithelial cell was 159.3 in 11 patients with long-term urethral catheter. This study showed that use of a LoFric catheter for intermittent catheterisation was associated with significantly lesser degree of urethral inflammatory response when compared to the use of an indwelling urethral catheter [10] 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. Patients Regional Spinal Injuries Centre, Southport is a purposebuilt spinal unit situated in the Northwest coast of England. Spinal cord injury patients from north Wales, Merseyside, the Northwest of England, and Cumbria are referred to this unit for initial treatment. Thereafter, the spinal unit provides life-long follow-up for these patients. Patients are reviewed every 12 to 18 months, or earlier, if required. 1967 patients were registered with the Regional Spinal Injuries Centre, Southport up to 31 December 1997. A preliminary letter about this study along with a self-addressed stamped envelope will be sent to all patients, who attended the spinal unit clinics during the past four years or, those who were discharged from the spinal unit during the last four years. (See additional file 1: 19 November 2001 Preliminary letter to Patient Urinary Infection Project.doc). A copy of Patient information sheet will be sent to those patients who evince interest in this study. (See additional file 2: 19 November 2001 Patient Information Sheet.doc). Those patients, who express their willingness to participate in this study, will come to the spinal unit for detailed discussion of the study with one of the investigators. If a patient agrees to participate in the study, informed consent will be taken from him and a letter will be sent the patient's general practitioner. (See additional file 3: 19 November 2001 Letter to General Practitioner Urine Infection Project.doc and additional file 4: 18 July 2001 Consent Symptomatic Urinary infection in SCI.doc) Male spinal cord injury patients will be enrolled in this study in a consecutive manner until the target is reached. Following four groups of male patients will be recruited for this study. Table 1 BMC Urology 2001, 1:2 http://www.biomedcentral.com/1471-2490/1/2 The criteria for inclusion in this study are: 1. Male patients with neuropathic bladder due to spinal cord injury who are registered with the Regional Spinal Injuries Centre, Southport 2. Age: 18 years or above 3. Patients should be able to give informed consent for participation in the study. If a patient is unable to give written consent because of physical disability, a written affirmation of consent will be taken in his presence from his relative or carer. 4. Patients who are willing to be followed-up for a period of 36 months from the date of recruitment. This will involve fortnightly telephonic contact with the spinal unit and attendance in the spinal unit whenever they develop symptomatic urinary infection. 5. Patients should be willing to maintain a record of adverse events related to urinary catheter and the drainage system, and predisposing factors for the occurrence of 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 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. On enrolment, the participants will be given lists of (1) symptoms, which may be suggestive of acute urinary infection, (2) possible predisposing factors for the occurrence of urinary infection, and (3) adverse events related to urinary catheter and urine drainage system. The participants will be asked to record in a diary the occurrence of any of the above feature on a daily basis. An example is given in Table 2. A staff of the spinal injuries unit will contact the participants by telephone every two weeks on a mutually agreed day and time. The staff member will enquire the follow-