Lower Urinary Tract SymptomsNCT03833752
Flexible V/S Rigid Cystoscopy In Men With Urinary Tract Infection
A study testing Diagnostic Flexible Cystosocpy and Diagnostic Rigid Cystoscopy in people with Lower Urinary Tract Symptoms, run by Maulana Azad Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Diagnostic Flexible Cystosocpy and Diagnostic Rigid Cystoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to 14 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with lower urinary tract symptoms
Who cannot join
- patients with Suprapubic catheter
- History of radical prostatectomy or cystoprostatectomy
- Clinical evidence of urethral stricture, prostatitis
- Patients with bacterial growth on urine culture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy
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.
Read the 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).
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Diagnostic Flexible Cystosocpy, Diagnostic Rigid Cystoscopy
- Keywords
- rigid cystoscopy, flexible cystosocpy, UTI, BPH
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Flexible CystosocpyDiagnostic 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 CystoscopyDiagnostic test
Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Cystoscopy | Experimental | Diagnostic flexible cystoscopy for the patients in this arm Receives: Diagnostic Test: Diagnostic Flexible Cystosocpy |
| Rigid Cystoscopy | Active comparator | Diagnostic rigid cystoscopy is done for the patients in this arm Receives: Diagnostic Test: Diagnostic Rigid Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: periprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion14 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maulana Azad Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gaurish Sawant, Maulana Azad Medical College
- Investigators
- PAWAN LAL, MS,DNB,DA, Study director, Professor, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833752
- Sponsor's protocol ID
- F.No./11IEC/MAMC/2016/113
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared to all researchers who produce the query for it.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study To Evaluate The Outcomes Between Rigid And Flexible Cystoscopy In Men With Lower Urinary Tract Symptoms Undergoing Diagnostic Cystoscopy
- ClinicalTrials.gov ID
- NCT03833752
- Acronym / sponsor ID
- F.No./11IEC/MAMC/2016/113
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- rigid cystoscopy, flexible cystosocpy, UTI, BPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maulana Azad Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Cystoscopy | Experimental | Diagnostic Test: Diagnostic Flexible CystosocpyDiagnostic flexible cystoscopy for the patients in this arm |
| Rigid Cystoscopy | Active comparator | Diagnostic Test: Diagnostic Rigid CystoscopyDiagnostic rigid cystoscopy is done for the patients in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with lower urinary tract symptoms
Key exclusion criteria (4 listed)
- patients with Suprapubic catheter
- History of radical prostatectomy or cystoprostatectomy
- Clinical evidence of urethral stricture, prostatitis
- Patients with bacterial growth on urine culture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Flexible CystosocpyEndoscopic Visualization of the Lower Urinary tract using either a flexible cystoscope for the purpose of aiding the establishment of a Urological Diagnosis. | Diagnostic test | Flexible Cystoscopy |
| Diagnostic Rigid CystoscopyEndoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis. | Diagnostic test | Rigid Cystoscopy |
Primary outcome
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Yes. IPD will be shared to all researchers who produce the query for it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAWAN LAL, MS,DNB,DA study director
Professor, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Flexible Cystosocpy and Diagnostic Rigid Cystoscopy in people with Lower Urinary Tract Symptoms, run by Maulana Azad Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Procedure Discomfort (time frame: periprocedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.