Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

Phase 2

Completed

• Conditions: Detrusor Underactivity; Urinary Obstruction
• Interventions: Diagnostic Test: Uroflowmetry

• Registration Number: NCT05359484
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-05-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-23
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study First Posted: 2022-05-03
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 238

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
detrusor underactivity	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.
bladder out flow obstruction	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.

Primary Outcome Measures

Name	Time	Method
Q average	preoperative test, it is done only once and comparative evaluation with other parameters will be done	Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry

Secondary Outcome Measures

Name	Time	Method
post voiding residual urine	preoperative test, it is done only once and comparative evaluation with other parameters will be done	amount of urine remains in the bladder after voiding as shown by Ultrasound in ml
Q max	preoperative test, it is done only once and comparative evaluation with other parameters will be done	uroflowmetry finding of maximum flow of urine in ml/sec
Q Average	preoperative test, it is done only once and comparative evaluation with other parameters will be done	uroflowmetry finding of average flow of urine in ml/sec

Trial Locations

Locations (1)

Ahmed Maher; 🇪🇬 Cairo, القاهرة, Egypt