Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05077852
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2021-10-12
Brief Title:
Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder
Sponsor:
Ankara Training and Research Hospital
Organization:
Ankara Training and Research Hospital
Study Overview
Official Title:
Intravesical Prostatic Protrusion Mimicking Urothelial Cell Carcinoma of the Bladder
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 189 in patients presenting with gross hematuria and 48 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 335 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None