Bladder CancerNCT05077852
Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder
An observational study of Bladder Cancer and Benign Prostatic Hyperplasia, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aim to determine the true positivity of bladder cancer identified in the bladder base, trigone or neck on ultrasonography (USG) in patients presenting with hematuria or lower urinary tract symptoms, by confirming with the gold standard cystoscopy and biopsy results. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Bladder Cancer, Benign Prostatic Hyperplasia, Hematuria
- What is being tested?
- Urethrocystoscopy
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2021to 30 Dec 2022
- Phase
- Observational
- 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by USG.
Who may be able to join
- Hematuria
- Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by USG.
Who cannot join
- Previous history of urinary tract tumor
- Chronic kidney disease
- Use of antimuscarinic drugs
- Active urinary tract infection
- Bladder stone
- Previous history of lower urinary tract surgery or urethral stricture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Training and Research Hospital
Ankara, Altindag, 06230
Ali Kaan Yildiz, +90 554 773 16 96, alikaanyildiz@gmail.com
About this study
In this study, investigators aim to determine the true positivity of bladder cancer identified in the bladder base, trigone or neck on ultrasonography (USG) in patients presenting with hematuria or lower urinary tract symptoms, by confirming with the gold standard cystoscopy and biopsy results. It also aims to explore criteria that would allow to differentiate between intravesical prostate protrusion (IPP) due to benign prostatic hyperplasia (BPH) and bladder cancer indicated at the bladder floor, trigone and neck by evaluating false positive results.
Read the detailed description
The most common symptom in bladder cancer is hematuria, although the rate of bladder cancer is 18.9% in patients presenting with gross hematuria and 4.8% in patients presenting with microscopic hematuria. For this reason, unnecessary and invasive procedures are applied to most of the patients investigated. USG is considered the first-line imaging technique in the evaluation of upper and lower urinary tract disease. It is a non-invasive technique that does not involve ionizing radiation, and can be used in the evaluation of kidney, prostate and bladder anatomy. In addition, USG is used to evaluate malignant tumors of the urinary system or benign causes such as BPH, urinary tract stones that may cause hematuria. Cystoscopy is the gold standard test for diagnosing bladder cancer, but cystoscopy causes discomfort and can carry risks such as infection and bleeding. Suspicious findings as a result of USG imaging may lead to more invasive tests such as cystoscopy. An example of this is performing a biopsy under general anesthesia to confirm a positive or negative finding. The annual costs of these examinations, which emerge as further examinations as a result of incorrect evaluations, are important. In England, patients with hematuria and normal investigation cost the National Health Service £33.5 million in one year.
IPP, or median lobe, is a phenomenon in which the prostate adenoma expands into the bladder along the plane of lowest resistance. IPP originating from the base of the prostate may enlarge and protrude into the bladder and form a regional lesion on the neck, trigone and posterior wall of the bladder. IPP cannot be detected adequately by conventional digital rectal examination (DRE), nor can it be diagnosed with sufficient accuracy by examinations such as noninvasive USG. In the literature, some studies evaluated the diagnosis of IPP by USG, and the full spectrum of IPP was not defined due to the scarcity of clinical series. IPP is seen as protruding structures within the bladder in the coronal plane of USG and can be easily misdiagnosed as a bladder-derived lesion. Thus, IPP, which is a manifestation of BPH, located at the base of the prostate and extending into the bladder, can easily be misdiagnosed as bladder cancer.
- Conditions
- Bladder Cancer, Benign Prostatic Hyperplasia, Hematuria
- Being tested
- Urethrocystoscopy
- Keywords
- Bladder cancer, Benign prostatic hyperplasia, Hematuria, Ultrasonography
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Hyperplasia, Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrethrocystoscopyDiagnostic test
Patients diagnosed with a primary bladder cancer at the base, trigone or neck of the bladder with USG in the urology clinic will be evaluated with urethrocystoscopy. With urethrocystoscopy, patients definitive diagnosed with bladder cancer and IPP.
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopy Bladder Cancer | Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by cystoscopy. Receives: Diagnostic Test: Urethrocystoscopy | |
| Cystoscopy IPP | Patients diagnosed with intravesical prostate protrusion (IPP) at the base, trigone or neck of the bladder by cystoscopy. Receives: Diagnostic Test: Urethrocystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of a positive screening test truly have the bladder cancer
Rate of a positive screening test truly have the bladder cancer in patients who diagnosed with bladder cancer at the base, trigone or neck by USG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start12 Dec 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077852
- Sponsor's protocol ID
- IPP-BC
- Status last verified
- Feb 2022
- First submitted
- 12 Oct 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khadhouri S, Gallagher KM, MacKenzie K, Shah TT, Gao C, Moore S, Zimmermann E, Edison E, Jefferies M, Nambiar A, MacLennan G, McGrath JS, Kasivisvanathan V; IDENTIFY Protocol Collaborators Group. IDENTIFY: The investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer: A multicentre cohort study. Int J Surg Protoc. 2020 Feb 28;21:8-12. doi: 10.1016/j.isjp.2020.02.002. eCollection 2020.
PubMed 32322764Gandhi J, Weissbart SJ, Kim AN, Joshi G, Kaplan SA, Khan SA. Clinical Considerations for Intravesical Prostatic Protrusion in the Evaluation and Management of Bladder Outlet Obstruction Secondary to Benign Prostatic Hyperplasia. Curr Urol. 2018 Oct;12(1):6-12. doi: 10.1159/000447224. Epub 2018 Jun 30.
PubMed 30374274Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.
PubMed 27317986
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT05077852
- Acronym / sponsor ID
- IPP-BC
- Conditions
- Bladder Cancer, Benign Prostatic Hyperplasia, Hematuria
- Keywords
- Bladder cancer, Benign prostatic hyperplasia, Hematuria, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 14 Oct 2021 (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.
In this study, investigators aim to determine the true positivity of bladder cancer identified in the bladder base, trigone or neck on ultrasonography (USG) in patients presenting with hematuria or lower urinary tract symptoms, by confirming with the gold standard cystoscopy and biopsy results. It also aims to explore criteria that would allow to differentiate between intravesical prostate protrusion (IPP) due to benign prostatic hyperplasia (BPH) and bladder cancer indicated at the bladder floor, trigone and neck by evaluating false positive results.
Detailed description
The most common symptom in bladder cancer is hematuria, although the rate of bladder cancer is 18.9% in patients presenting with gross hematuria and 4.8% in patients presenting with microscopic hematuria. For this reason, unnecessary and invasive procedures are applied to most of the patients investigated. USG is considered the first-line imaging technique in the evaluation of upper and lower urinary tract disease. It is a non-invasive technique that does not involve ionizing radiation, and can be used in the evaluation of kidney, prostate and bladder anatomy. In addition, USG is used to evaluate malignant tumors of the urinary system or benign causes such as BPH, urinary tract stones that may cause hematuria. Cystoscopy is the gold standard test for diagnosing bladder cancer, but cystoscopy causes discomfort and can carry risks such as infection and bleeding. Suspicious findings as a result of USG imaging may lead to more invasive tests such as cystoscopy. An example of this is performing a biopsy under general anesthesia to confirm a positive or negative finding. The annual costs of these examinations, which emerge as further examinations as a result of incorrect evaluations, are important. In England, patients with hematuria and normal investigation cost the National Health Service £33.5 million in one year.
IPP, or median lobe, is a phenomenon in which the prostate adenoma expands into the bladder along the plane of lowest resistance. IPP originating from the base of the prostate may enlarge and protrude into the bladder and form a regional lesion on the neck, trigone and posterior wall of the bladder. IPP cannot be detected adequately by conventional digital rectal examination (DRE), nor can it be diagnosed with sufficient accuracy by examinations such as noninvasive USG. In the literature, some studies evaluated the diagnosis of IPP by USG, and the full spectrum of IPP was not defined due to the scarcity of clinical series. IPP is seen as protruding structures within the bladder in the coronal plane of USG and can be easily misdiagnosed as a bladder-derived lesion. Thus, IPP, which is a manifestation of BPH, located at the base of the prostate and extending into the bladder, can easily be misdiagnosed as bladder cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystoscopy Bladder Cancer | – | Diagnostic Test: UrethrocystoscopyPatients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by cystoscopy. |
| Cystoscopy IPP | – | Diagnostic Test: UrethrocystoscopyPatients diagnosed with intravesical prostate protrusion (IPP) at the base, trigone or neck of the bladder by cystoscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by USG.
Key inclusion criteria (2 listed)
- Hematuria
- Patients diagnosed with primary bladder cancer at the base, trigone or neck of the bladder by USG.
Key exclusion criteria (6 listed)
- Previous history of urinary tract tumor
- Chronic kidney disease
- Use of antimuscarinic drugs
- Active urinary tract infection
- Bladder stone
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 |
|---|---|---|
| UrethrocystoscopyPatients diagnosed with a primary bladder cancer at the base, trigone or neck of the bladder with USG in the urology clinic will be evaluated with urethrocystoscopy. With urethrocystoscopy, patients definitive diagnosed with bladder cancer and IPP. | Diagnostic test | Cystoscopy Bladder Cancer, Cystoscopy IPP |
Primary outcome
Rate of a positive screening test truly have the bladder cancer
Time frame: 3 months
Rate of a positive screening test truly have the bladder cancer in patients who diagnosed with bladder cancer at the base, trigone or neck by USG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Background: PubMed 32322764Khadhouri S, Gallagher KM, MacKenzie K, Shah TT, Gao C, Moore S, Zimmermann E, Edison E, Jefferies M, Nambiar A, MacLennan G, McGrath JS, Kasivisvanathan V; IDENTIFY Protocol Collaborators Group. IDENTIFY: The investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer: A multicentre cohort study. Int J Surg Protoc. 2020 Feb 28;21:8-12. doi: 10.1016/j.isjp.2020.02.002. eCollection 2020.
- Background: PubMed 30374274Gandhi J, Weissbart SJ, Kim AN, Joshi G, Kaplan SA, Khan SA. Clinical Considerations for Intravesical Prostatic Protrusion in the Evaluation and Management of Bladder Outlet Obstruction Secondary to Benign Prostatic Hyperplasia. Curr Urol. 2018 Oct;12(1):6-12. doi: 10.1159/000447224. Epub 2018 Jun 30.
- Background: PubMed 27317986Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.
- Individual participant dataSharing planned: No
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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.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Benign Prostatic Hyperplasia, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Kaan Yildiz (+90 554 773 16 96, alikaanyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of a positive screening test truly have the bladder cancer (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077852, which also lists 3 linked publications.
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 15 Mar 2022.