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

NCT ID: NCT03833752

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-01-14

Brief Summary

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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

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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).

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Flexible Cystoscopy

Diagnostic flexible cystoscopy for the patients in this arm

Group Type EXPERIMENTAL

Diagnostic Flexible Cystosocpy

Intervention Type 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.

Rigid Cystoscopy

Diagnostic rigid cystoscopy is done for the patients in this arm

Group Type ACTIVE_COMPARATOR

Diagnostic Rigid Cystoscopy

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Maulana Azad Medical College

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gaurish Sawant

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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PAWAN LAL, MS,DNB,DA

Role: STUDY_DIRECTOR

Professor, Department of Surgery

Locations

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Maulana Aazad Medical College

New Delhi, , India

Site Status

Countries

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India

Other Identifiers

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F.No./11IEC/MAMC/2016/113

Identifier Type: -

Identifier Source: org_study_id

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