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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Diagnostic Test: Diagnostic Rigid Cystoscopy; Diagnostic Test: Diagnostic Flexible Cystosocpy

• Registration Number: NCT03833752
• Lead Sponsor: Maulana Azad Medical College

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).

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-14
• Status Verified: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rigid Cystoscopy	Diagnostic Rigid Cystoscopy	Diagnostic rigid cystoscopy is done for the patients in this arm
Flexible Cystoscopy	Diagnostic Flexible Cystosocpy	Diagnostic flexible cystoscopy for the patients in this arm

Primary Outcome Measures

Name	Time	Method
Post Procedure Discomfort	periprocedure	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	periprocedure	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.

Trial Locations

Locations (1)

Maulana Aazad Medical College; 🇮🇳 New Delhi, India