Flexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833752
• Other study ID #: F.No./11IEC/MAMC/2016/113
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 14, 2018

Study information

• Verified date: February 2019
• Source: Maulana Azad Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 14, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urinary Tract Infections

Intervention

Diagnostic Test:
• Diagnostic Flexible Cystosocpy
Endoscopic Visualization of the Lower Urinary tract using either a flexible cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
• Diagnostic Rigid Cystoscopy
Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.

Locations

Country	Name	City	State
India	Maulana Aazad Medical College	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Maulana Azad Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	periprocedure
Primary	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.	periprocedure