Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

NCT05359484 | Completed Phase 2 DMC

• 1 other identifier: K22/2019
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Obstruction; Detrusor Underactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Q max

  preoperative test, it is done only once and comparative evaluation with other parameters will be done

• Q Average

  preoperative test, it is done only once and comparative evaluation with other parameters will be done

• post voiding residual urine

  preoperative test, it is done only once and comparative evaluation with other parameters will be done

Study Arms (2)

detrusor underactivity

EXPERIMENTAL

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

bladder out flow obstruction

EXPERIMENTAL

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

Interventions

Uroflowmetry 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; detrusor underactivity

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: the main part of the bladder outlet obstruction is caused by the prostate that is why this study is based in male population
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher

Cairo, Cairo Governorate, 11757, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

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

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 3, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

EG (1)