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

NCT03833752 | Completed

• 1 other identifier: F.No./11IEC/MAMC/2016/113
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

rigid cystoscopy; flexible cystosocpy; UTI; BPH

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Flexible Cystoscopy

EXPERIMENTAL

Diagnostic flexible cystoscopy for the patients in this arm

Diagnostic Test: Diagnostic Flexible Cystosocpy

Rigid Cystoscopy

ACTIVE COMPARATOR

Diagnostic rigid cystoscopy is done for the patients in this arm

Diagnostic Test: Diagnostic Rigid Cystoscopy

Interventions

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.

Flexible Cystoscopy

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.

Rigid Cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with lower urinary tract symptoms

You may not qualify if:

• patients with Suprapubic catheter
• History of radical prostatectomy or cystoprostatectomy
• Clinical evidence of urethral stricture, prostatitis
• Patients with bacterial growth on urine culture

Sponsors & Collaborators

• Maulana Azad Medical College: lead

Study Sites (1)

Maulana Aazad Medical College

New Delhi, 110002, India

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• PAWAN LAL, MS,DNB,DA

  Professor, Department of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 14, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IN (1)