Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05359484
Collaborator
(none)
238
1
2
28
8.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Uroflowmetry
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
238 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Usage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractilityUsage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractility
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Uroflowmetry Parameter (Delta Q Value) as a Noninvasive Tool to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Diagnostic Test: 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.

Experimental: 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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. Q average [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 Outcome Measures

  1. Q max [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmed Maher Cairo القاهرة Egypt 11757

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Maher Gamil Ahmed Higazy, principle investigator, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05359484
Other Study ID Numbers:
  • K22/2019
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022