Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05359484
Other study ID # K22/2019
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2019
Est. completion date May 1, 2021

Study information

Verified date April 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 238
Est. completion date May 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Egypt Ahmed Maher Cairo ???????

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Q max uroflowmetry finding of maximum flow of urine in ml/sec preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary Q Average uroflowmetry finding of average flow of urine in ml/sec preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary post voiding residual urine amount of urine remains in the bladder after voiding as shown by Ultrasound in ml preoperative test, it is done only once and comparative evaluation with other parameters will be done
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT04161183 - Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB) N/A
Completed NCT04543552 - A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
Completed NCT04336280 - Detrusor Underactivity: Presentation and Urodynamic Characteristics
Completed NCT00441428 - Safety And Efficacy Of Solifenacin In Men With Overactive Bladder (OAB) And Detrusor Underactivity Phase 2
Completed NCT05470751 - GentleCathâ„¢ for Men Intermittent Catheter With FeelCleanâ„¢ Technology
Completed NCT04981080 - DU and BOO in Women With and Without Symptoms of VD
Recruiting NCT06020963 - Can Acupoint Low Intensity Shockwave Therapy Improve Bladder Voiding Efficiency N/A
Completed NCT03175029 - Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder. Phase 2
Active, not recruiting NCT02193451 - Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods N/A