Clinical trial NCT05359484: Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction
Official title: Uroflowmetry Parameter (Delta Q Value) as a Noninvasive Tool to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Obstruction
Detrusor Underactivity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 238
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Usage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractility
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Q average
timeFrame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary outcomes:
measure: Q max
timeFrame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
measure: Q Average
timeFrame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
measure: post voiding residual urine
timeFrame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maher
state: القاهرة
Study officials:
References: