A Phase 2/3 interventional study of Uroflowmetry in Urinary Obstruction and Detrusor Underactivity, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Diagnostic
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).
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.
31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.
This study's enrollment of 238 is above the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.
Browse Urinary Bladder, Underactive studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
according to urodynamic, patients with weak urine stream were evaluated into 2 groups, either detrusor underactivity or bladder outflow obstruction From uroflowmetry, 5 variables including maximal flow rate (Qmax), average flow rate (Qave), voiding volume (VV), post void residual urine (PVR), and value of Qmax minus Qave (DeltaQ) were obtained.
Diagnostic Test: Uroflowmetry
according to urodynamic, patients with weak urine stream were evaluated into 2 groups, either detrusor underactivity or bladder outflow obstruction From uroflowmetry, 5 variables including maximal flow rate (Qmax), average flow rate (Qave), voiding volume (VV), post void residual urine (PVR), and value of Qmax minus Qave (DeltaQ) were obtained.
Diagnostic Test: Uroflowmetry
according to urodynamic, patients with weak urine stream were evaluated into 2 groups, either detrusor underactivity or bladder outflow obstruction From uroflowmetry, 5 variables including maximal flow rate (Qmax), average flow rate (Qave), voiding volume (VV), post-void residual urine (PVR), and value of Qmax minus Qaverage (DeltaQ) were obtained.
Q average
Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Q max
uroflowmetry finding of maximum flow of urine in ml/sec
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Q Average
uroflowmetry finding of average flow of urine in ml/sec
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
post voiding residual urine
amount of urine remains in the bladder after voiding as shown by Ultrasound in ml
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Ran from Jan 2019 to primary completion in Jan 2021, 24 months.
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Urinary Bladder, Underactive →