Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

Detrusor Underactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359484
• Other study ID #: K22/2019
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: May 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Detrusor Underactivity
• Hypokinesia
• Urinary Bladder Neck Obstruction
• Urinary Bladder, Underactive
• Urinary Obstruction

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed Maher	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Q average	Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry	preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary	Q max	uroflowmetry finding of maximum flow of urine in ml/sec	preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary	Q Average	uroflowmetry finding of average flow of urine in ml/sec	preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary	post voiding residual urine	amount of urine remains in the bladder after voiding as shown by Ultrasound in ml	preoperative test, it is done only once and comparative evaluation with other parameters will be done