Material and Method
A total of 41 male patients with low risk NMIBC were randomized into two groups. The patients were randomized according to the sequence of admittance to our department. The study was designed as cross over experimental. Inclusion criteria was pathologically low risk NMIBC (Ta, G1/low grade, <3cm, primary) after first transurethral resection of bladder tumor (TURBT). Exclusion criteria were T1, G2,3/high grade, carcinoma in situ, recurrence tumor, >3cm and patients who underwent re-TURBT and/or intravesical treatment. The patients (n=20) in Group 1 were performed the first cystoscopy with flexible instrument (15.5 Fr, Karl Storz, Tutlingen, Germany) at third month after TURBT and the second cystoscopy with rigid instrument (15.5 Fr, Olympus Europe Holding GmbH, Hamburg, Germany) at sixth month after TURBT. The patients (n=21) in Group 2 were performed the first cystoscopy with rigid instrument at third month TURBT and the second cystoscopy with flexible instrument at sixth month after TURBT.
The height, weight and socio-demographic data of all patients were recorded before the first cystoscopy. All of the patients filled in the International Index of Erectile Function (IIEF) and the Short Form-36 (SF-36) questionnaires before and the third month after the first and second cystoscopy, and the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) before and the first week after the cystoscopies. The IIEF is used to assess the male sexual function and consists of 15 items divided into 5 subscales including erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction. The SF-36 is used to indicate the health status of particular populations and to measure the impact of clinical and social interventions. The ICIQ-MLUTS consists of 13 items, evaluating 6 storage symptoms and 5 emptying symptoms as well as frequency and nocturia questions. The validation and reliability studies of Turkish version of the IIEF (7), SF-36(8) and ICIQ-MLUTS (9) were made by Turkish Society of Andrology, Kocyigit et al. and Mertoglu et al., respectively. Microscopic urinalyses of the patients were made the first week after the cystoscopies.
Prior to the cystoscopy, 10mL of the %2 lidocaine gel was instilled in the urethra. After 10 minutes, cystoscopy was carried out with the patient in the dorsolithotomy position by the same surgeon (O.U.). The patients were blinded by a drape to the type of cystoscope being used. An independent person presented the patients with a visual analog scale (VAS) and asked to mark their pain status after shortly the procedure. The VAS consisted of a 10-cm horizontal line (0 being no pain and 10 being the worst pain imaginable). After the second cystoscopy, the patients were asked which cystoscope they preferred. Informed consent was obtained from all the patients who participated in the study and Local Ethics Committee approved the study protocol (No: 20478486-98). The patients’ enrolment algorithm has been illustrated in Figure 1.
Statistical analyses were performed using SPSS 16.0 (SPSS Inc., Chicago, IL, USA). All the data of the two groups were compared using the Mann Withney U Test. Also the data of the first cystoscopies of each group were compared with the data of the second ones using the Wilcoxon Signed Ranks Test. The changes of scores after the procedures in the both groups were calculated as well. These changes were analyzed for assessing the effect on VAS, IIEF, MLUTS and SF-36 scores of cystoscopy type by using the Multiple Linear Regression. The impacts on LUTS, sexual function, quality of life and pain of type of cystoscopy were evaluated using multivariate analysis. A p value less than 0,05 was considered statiatically significant.