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Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

Primary Purpose

Urinary Obstruction, Detrusor Underactivity

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Uroflowmetry
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Obstruction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmed Maher

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

detrusor underactivity

bladder out flow obstruction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Q average
Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry

Secondary Outcome Measures

Q max
uroflowmetry finding of maximum flow of urine in ml/sec
Q Average
uroflowmetry finding of average flow of urine in ml/sec
post voiding residual urine
amount of urine remains in the bladder after voiding as shown by Ultrasound in ml

Full Information

First Posted
April 23, 2022
Last Updated
April 29, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05359484
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Obstruction, Detrusor Underactivity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Usage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractility
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
detrusor underactivity
Arm Type
Experimental
Arm Description
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.
Arm Title
bladder out flow obstruction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Uroflowmetry
Intervention Description
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 Outcome Measure Information:
Title
Q average
Description
Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry
Time Frame
preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary Outcome Measure Information:
Title
Q max
Description
uroflowmetry finding of maximum flow of urine in ml/sec
Time Frame
preoperative test, it is done only once and comparative evaluation with other parameters will be done
Title
Q Average
Description
uroflowmetry finding of average flow of urine in ml/sec
Time Frame
preoperative test, it is done only once and comparative evaluation with other parameters will be done
Title
post voiding residual urine
Description
amount of urine remains in the bladder after voiding as shown by Ultrasound in ml
Time Frame
preoperative test, it is done only once and comparative evaluation with other parameters will be done

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
the main part of the bladder outlet obstruction is caused by the prostate that is why this study is based in male population
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ahmed Maher
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11757
Country
Egypt

12. IPD Sharing Statement

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Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

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