Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05359484 |
Other study ID # |
K22/2019 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
January 1, 2019 |
Est. completion date |
May 1, 2021 |
Study information
Verified date |
April 2022 |
Source |
Ain Shams University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To determine the significance of delta Q value (Qmax - Qave) in discrimination between BOO
and DU, to avoid invasive studies (pressure flow studies (PFSs)) and replace them with
noninvasive study (uroflowmetry).
Description:
lower urinary tract symptoms (LUTS) in old male patients are usually secondary to prostatic
hyperplasia. However, it is becoming clear nowadays that prostatic enlargement is not always
the cause of male LUTS, and other factors could cause male LUTS in the presence of benign
prostate enlargement (BPE).
Two clinical situations are common in elderly patients like Bladder Outlet Obstruction (BOO)
and Detrusor underactivity (DU) they affect the voiding phase in elderly men markedly.
To distinguish one from another may be challenging and could be only done by urodynamic study
(UDS), which is the gold standard for diagnosis.
A urodynamic study is an invasive procedure, with side effects of pain and urinary tract
infection, and the need for special equipment and expertise has limited its widespread use
and made it very stressful for the patients.
On the other hand, Uroflowmetry is a non-invasive procedure that could be used in patients'
assessments. A term of Delta Q is being used that focuses on the difference between (Qmax)
and (Q-average). The hypothesis is that Delta Q would be lower in Detrusor underactivity
because of the undermined detrusor function decreasing both average and maximum urine flow
rate, but it is higher in BOO, which has normal detrusor contraction during the voiding
phase.
Based on the concept uroflow can be used to replace urodynamic studies to differentiate
between these 2 entities and hence to determine the proper management plan and to be a
prognostic factor before surgical intervention.