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Completed

NCT Number: NCT05359484

Delta Q Value 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).

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Key information

Conditions

Urinary Obstruction Detrusor Underactivity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ahmed Maher

Cairo, Cairo Governorate, 11757, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Q average

    Time frame: 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 outcomes

  1. Q max

    Time frame: 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

  2. Q Average

    Time frame: 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

  3. post voiding residual urine

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 3, 2022
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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