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.