Back to resultsFlexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection
Primary Purpose
Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Diagnostic Flexible Cystosocpy
Diagnostic Rigid Cystoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lower Urinary Tract Symptoms focused on measuring rigid cystoscopy, flexible cystosocpy, UTI, BPH
Eligibility Criteria
Inclusion Criteria:
- patients with lower urinary tract symptoms
Exclusion Criteria:
- patients with Suprapubic catheter
- History of radical prostatectomy or cystoprostatectomy
- Clinical evidence of urethral stricture, prostatitis
- Patients with bacterial growth on urine culture
Sites / Locations
- Maulana Aazad Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flexible Cystoscopy
Rigid Cystoscopy
Arm Description
Diagnostic flexible cystoscopy for the patients in this arm
Diagnostic rigid cystoscopy is done for the patients in this arm
Outcomes
Primary Outcome Measures
Post Procedure Discomfort
Discomfort experienced immediately post procedure by the patient defined as a Visual Analogue Scale score of more than 3 (range is from 1 to 10)
Duration of Procedure
time taken to complete the entire test in minutes starting from insertion of the cystoscope through the urethral meatus, visualising the entire bladder and urethra , till the removal of the scope after making the observations.
Secondary Outcome Measures
Full Information
NCT ID
NCT03833752
First Posted
February 6, 2019
Last Updated
February 8, 2019
Sponsor
Maulana Azad Medical College
1. Study Identification
Unique Protocol Identification Number
NCT03833752
Brief Title
Flexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection
Official Title
Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maulana Azad Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to perform a randomized study, comparing the outcomes of the above two types of cystoscopy in terms of discomfort experienced by the patient, while undergoing the procedure.
Detailed Description
Cystoscopy is a commonly performed routine outpatient procedure and an essential diagnostic tool in urology.Compared with flexible endoscopes, rigid instruments offer better image quality, a wider lumen of the working channel, improved irrigant flow and superior handiness. However, flexible cystoscopes provide more options for patient positioning, enable smooth passage over an elevated bladder neck or median lobe, facilitate full inspection of the bladder because of their movable tip and, what is most important is it significantly improve patient comfort(patient can be positioned in any comfortable position).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
rigid cystoscopy, flexible cystosocpy, UTI, BPH
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexible Cystoscopy
Arm Type
Experimental
Arm Description
Diagnostic flexible cystoscopy for the patients in this arm
Arm Title
Rigid Cystoscopy
Arm Type
Active Comparator
Arm Description
Diagnostic rigid cystoscopy is done for the patients in this arm
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic Flexible Cystosocpy
Intervention Description
Endoscopic Visualization of the Lower Urinary tract using either a flexible cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic Rigid Cystoscopy
Intervention Description
Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
Primary Outcome Measure Information:
Title
Post Procedure Discomfort
Description
Discomfort experienced immediately post procedure by the patient defined as a Visual Analogue Scale score of more than 3 (range is from 1 to 10)
Time Frame
periprocedure
Title
Duration of Procedure
Description
time taken to complete the entire test in minutes starting from insertion of the cystoscope through the urethral meatus, visualising the entire bladder and urethra , till the removal of the scope after making the observations.
Time Frame
periprocedure
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with lower urinary tract symptoms
Exclusion Criteria:
patients with Suprapubic catheter
History of radical prostatectomy or cystoprostatectomy
Clinical evidence of urethral stricture, prostatitis
Patients with bacterial growth on urine culture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PAWAN LAL, MS,DNB,DA
Organizational Affiliation
Professor, Department of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Maulana Aazad Medical College
City
New Delhi
ZIP/Postal Code
110002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared to all researchers who produce the query for it.
Learn more about this trial
Flexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection
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