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

Sponsor

Maulana Azad Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT03833752

Collaborator

(none)

Enrollment

Location

Arms

12.4

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms	Diagnostic Test: Diagnostic Flexible Cystosocpy Diagnostic Test: Diagnostic Rigid Cystoscopy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Jan 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flexible Cystoscopy Diagnostic flexible cystoscopy for the patients in this arm	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.
Active Comparator: Rigid Cystoscopy Diagnostic rigid cystoscopy is done for the patients in this arm	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.

Arm

Intervention/Treatment

Experimental: Flexible Cystoscopy

Diagnostic flexible cystoscopy for the patients in this arm

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.

Active Comparator: Rigid Cystoscopy

Diagnostic rigid cystoscopy is done for the patients in this arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maulana Aazad Medical College	New Delhi		India	110002

Sponsors and Collaborators

Maulana Azad Medical College

Investigators

Study Director: PAWAN LAL, MS,DNB,DA, Professor, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Gaurish Sawant, resident doctor, Maulana Azad Medical College

ClinicalTrials.gov Identifier:

NCT03833752

Other Study ID Numbers:

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

First Posted:

Feb 7, 2019

Last Update Posted:

Feb 12, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Gaurish Sawant, resident doctor, Maulana Azad Medical College

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Feb 12, 2019