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

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).

Study Overview

• Status: Completed
• Conditions: Urinary Obstruction; Detrusor Underactivity
• Intervention / Treatment: Diagnostic test: 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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • القاهرة
    • Cairo, القاهرة, Egypt, 11757
      • Ahmed Maher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: detrusor underactivity; 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.
Experimental: bladder out flow obstruction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Dyskinesias; Urethral Diseases; Urethral Obstruction; Hypokinesia; Urinary Bladder Neck Obstruction; Urinary Bladder, Underactive
• Other Study ID Numbers: K22/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No