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Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

Uroflowmetry Parameter (Delta Q Value) as a Noninvasive Tool to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05359484
Enrollment
238
Registered
2022-05-03
Start date
2019-01-01
Completion date
2021-05-01
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detrusor Underactivity, Urinary Obstruction

Brief 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).

Detailed 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.

Interventions

DIAGNOSTIC_TESTUroflowmetry

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Usage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractility

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* male patients aged over 50 years complaining of voiding symptoms * International Prostatic Symptom Score (IPSS) 8 points or more, * serum prostate-specific antigen (PSA) below 4 ng/ml * no hematuria or pyuria.

Exclusion criteria

* Patients who were unable to complete the voiding study were deemed not eligible to participate in this review. * patients with neurological causes of voiding dysfunction * history of urinary tract abnormalities/lithiasis, lower urinary tract surgeries, urinary tract malignancy. * acute UTI were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Q averagepreoperative test, it is done only once and comparative evaluation with other parameters will be doneQ average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry

Secondary

MeasureTime frameDescription
Q maxpreoperative test, it is done only once and comparative evaluation with other parameters will be doneuroflowmetry finding of maximum flow of urine in ml/sec
Q Averagepreoperative test, it is done only once and comparative evaluation with other parameters will be doneuroflowmetry finding of average flow of urine in ml/sec
post voiding residual urinepreoperative test, it is done only once and comparative evaluation with other parameters will be doneamount of urine remains in the bladder after voiding as shown by Ultrasound in ml

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026