Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

NCT ID: NCT05359484

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-05-01

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.

Conditions

Urinary Obstruction; Detrusor Underactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Uroflowmetry

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: EXPERIMENTAL

Uroflowmetry

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maher Gamil Ahmed Higazy

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Maher

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

K22/2019

Identifier Type: -

Identifier Source: org_study_id