search
Back to results

The Accuracy of Pulsed Fluoroscopy Retrograde Urethrogram Vs the Traditional Retrograde Urethrogram In Diagnosing Urethral Stricture

Primary Purpose

Urethral Stricture

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Retrograde Urethrogram
Sponsored by
Northern Ontario School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urethral Stricture focused on measuring Diagnosing Urethral Stricture, Pulsed Fluoroscopy Retrograde Urethrogram, Traditional Retrograde Urethrogram

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males over 18 years of age at the time of enrollment Referred to urology for suspected diagnosis of stricture urethra. Written informed consent to participate collected Ability to comply with study procedures

Exclusion Criteria:

Co-existing urethral fistula, or requiring fluoroscopic guided manipulation Active urinary tract infection not yet appropriately treated Pre-existing conditions, which, in the opinion of the investigator, interfere with the conduct of the study Lack capacity to provide free and informed written consent

Sites / Locations

  • Thunder Bay Regional Health Science CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed Fluoroscopy Retrograde Urethrogram

Traditional Retrograde Urethrogram

Arm Description

Outcomes

Primary Outcome Measures

diagnostic accuracy of pulsed fluoroscopy retrograde urethrogram
Sensitivity, specificity, positive predictive value, and negative predictive value of pulsed fluoroscopy retrograde urethrogram
diagnostic accuracy of pulsed traditional retrograde urethrogram
Sensitivity, specificity, positive predictive value, and negative predictive value of pulsed traditional retrograde urethrogram

Secondary Outcome Measures

Intraprocedural adverse events
Any adverse events (e.g., extravasation of contrast)

Full Information

First Posted
August 25, 2022
Last Updated
May 11, 2023
Sponsor
Northern Ontario School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05519566
Brief Title
The Accuracy of Pulsed Fluoroscopy Retrograde Urethrogram Vs the Traditional Retrograde Urethrogram In Diagnosing Urethral Stricture
Official Title
The Diagnostic Accuracy of Pulsed Fluoroscopy Retrograde Urethrogram Vs the Traditional Retrograde Urethrogram In Diagnosing Urethral Stricture: A Randomized Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Ontario School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
Keywords
Diagnosing Urethral Stricture, Pulsed Fluoroscopy Retrograde Urethrogram, Traditional Retrograde Urethrogram

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Fluoroscopy Retrograde Urethrogram
Arm Type
Experimental
Arm Title
Traditional Retrograde Urethrogram
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Retrograde Urethrogram
Intervention Description
Fluoroscopy Retrograde Urethrogram Vs the Traditional Retrograde Urethrogram
Primary Outcome Measure Information:
Title
diagnostic accuracy of pulsed fluoroscopy retrograde urethrogram
Description
Sensitivity, specificity, positive predictive value, and negative predictive value of pulsed fluoroscopy retrograde urethrogram
Time Frame
Intra-procedure (during the urethroplasty)
Title
diagnostic accuracy of pulsed traditional retrograde urethrogram
Description
Sensitivity, specificity, positive predictive value, and negative predictive value of pulsed traditional retrograde urethrogram
Time Frame
Intra-procedure (during the urethroplasty)
Secondary Outcome Measure Information:
Title
Intraprocedural adverse events
Description
Any adverse events (e.g., extravasation of contrast)
Time Frame
Intra-procedure (during the urethroplasty)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males over 18 years of age at the time of enrollment Referred to urology for a suspected diagnosis of stricture urethra. Ability to get written informed consent to participate Ability to comply with study procedures Exclusion Criteria: Co-existing urethral fistula, or requiring fluoroscopic guided manipulation Active urinary tract infection not yet appropriately treated Pre-existing conditions, which, in the opinion of the investigator, interfere with the conduct of the study Lack of capacity to provide free and informed written consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walid Shahrour, MD
Phone
(807) 285-9292
Email
Walid.Shahrour@tbh.net
First Name & Middle Initial & Last Name or Official Title & Degree
Vahid Mehrnoush, MD
Phone
(807) 285-9292
Email
vahidmehrnoush7@gmail.com
Facility Information:
Facility Name
Thunder Bay Regional Health Science Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walid Shahrour, MD
Phone
(807) 285-9292
Email
Walid.Shahrour@tbh.net
Ext
Shahrour
Email
Walid.Shahrour@tbh.net
First Name & Middle Initial & Last Name & Degree
Walid Shahrour, MD

12. IPD Sharing Statement

Learn more about this trial

The Accuracy of Pulsed Fluoroscopy Retrograde Urethrogram Vs the Traditional Retrograde Urethrogram In Diagnosing Urethral Stricture

We'll reach out to this number within 24 hrs