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OpenTrials
Completed

NCT Number: NCT03833752

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maulana Aazad Medical College

New Delhi, 110002, India

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Flexible Cystosocpy

Diagnostic Test

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

Diagnostic Test

Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.

Primary outcomes

  1. Post Procedure Discomfort

    Time frame: 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)

  2. Duration of Procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maulana Azad Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 7, 2019
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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