This study is designed as a prospective comparative randomized clinical study to determine
the diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative
predictive value) of pulsed fluoroscopy retrograde urethrogram for urethral stricture
disease. The target population includes patients scheduled for retrograde urethrogram either
new referral or follow up at Thunder Bay Regional Health Sciences Centre (TBRHSC) for
treatment of urethral stricture who meet the specific eligibility criteria. The overall
number of participants targeted will be 46. Upon presentation to the urology clinic or
ambulatory care unit, the treating urologist/investigator will notify the patient of an
opportunity to participate in the study. If the patient is interested, a research team member
who is not directly involved in the patient care will be invited to discuss the study to the
potential participant.
The study team member will obtain a full-informed consent form the potential participant.
Following informed consent, participants will be screened to ensure they meet the specific
eligibility requirements of this study, through consultation with their medical records and
the treating urologist. Randomization will be conducted in a 1:1 allocation ratio to either
treatment arm: (1) the Pulsed fluoroscopy retrograde urethrogram, or (2) the Traditional
retrograde urethrogram.
Using an Excel sheet, the RAND function will give a random code. The random code is a figure
ranging from 0.00000000 to 0.9999999999. A 0.5 cut-off code will be used, below which we will
use the small blocks of 4 cells (4 rows of excel) and above which we will use the large
blocks of 8 cells (8 rows of excel). Participants will undergo procedures according to the
order of randomization Participants will undergo either Pulsed fluoroscopy retrograde
urethrogram or Traditional retrograde urethrogram, depending on the treatment arm they are
randomized to. Clinical data such as stricture location, stricture length and possible
adverse effects will be recorded. According to the urologist decision based on data obtained
during RUG, participant will be scheduled for urethroplasty or cystoscopy. All participants
will undergo these procedures according to standard care procedures at TBRHSC.
Data collection at baseline will include demographics, and relevant medical history. All
retrograde urethrogram data including the type of urethrogram, the urethrogram date,
fluoroscopy time, cumulative radiation dose, stricture location, stricture length and
intraprocedural complications.
Furthermore, we will record intraoperative data such as operative date, stricture location
and stricture length. De-identified research files will be maintained in a secure office of a
research team member during the conduct of the study. De-identified research data will be
input into an electronic database that is password protected and maintained on research team
member's computers or encrypted USB devices. An enrolment log, linking Participant ID to
identifiable information will be maintained in hard copy in a locked office, or
electronically as a password-protected document on the TBRHSC network.
Only delegated research team members and the Principal Investigator will have access to
research and patient data.
Upon study closure, research records will be kept in secure storage in a research team
member's office for a period of 5 years. Following this, the files will be securely shredded,
and any electronic documents permanently deleted.
Data will be analyzed using the commercially available SPSS software version 26 (SPSS Inc.,
Chicago, IL, USA). For both techniques, data obtained during baseline and postoperative
urethrograms will be compared in terms of stricture location, stricture length, fluoroscopy
time, cumulative radiation dose and the occurrence of intraprocedural complications.
Categorical data will be compared using Chi-squared or Fisher test. Continuous data will be
analyzed using the T test or Mann-Whitney U test
Data obtained during urethroplasty will set as a standard of comparison to determine
sensitivity, specificity, positive predictive value and negative predictive value of pulsed
fluoroscopy and traditional urethrograms. For each comparison, 2 × 2 contingency tables were
used to present the results and calculate the diagnostic accuracy estimates with 95%
confidence intervals Data analysis will be done blindly regarding the type of performed
procedure. One procedure will be coded as "1" and the other will "2". Categorical variables
will be presented using number and percentage, and continuous variables will be presented
using median and ranges. Two-tailed p-values of less than 0.05 will be set for statistical
significance.