Urinary ObstructionPhase 2/3NCT05359484
Delta Q Value to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction
A Phase 2/3 study testing Uroflowmetry in people with Urinary Obstruction and Detrusor Underactivity, run by Ain Shams University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Urinary Obstruction, Detrusor Underactivity
- What is being tested?
- Uroflowmetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 May 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uroflowmetry Parameter (Delta Q Value) as a Noninvasive Tool 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).
Read the 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.
- Conditions
- Urinary Obstruction, Detrusor Underactivity
- Being tested
- Uroflowmetry
- Medical subject headings
- Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroflowmetryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| detrusor underactivity | Experimental | 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. Receives: Diagnostic Test: Uroflowmetry |
| bladder out flow obstruction | Experimental | 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. Receives: Diagnostic Test: Uroflowmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Q average
Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry
Measured: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Secondary outcomes (3)
Q max
uroflowmetry finding of maximum flow of urine in ml/sec
Measured: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Q Average
uroflowmetry finding of average flow of urine in ml/sec
Measured: preoperative test, it is done only once and comparative evaluation with other parameters will be done
post voiding residual urine
amount of urine remains in the bladder after voiding as shown by Ultrasound in ml
Measured: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary ObstructionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Usage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractility
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359484
- Sponsor's protocol ID
- K22/2019
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uroflowmetry Parameter (Delta Q Value) as a Noninvasive Tool to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction
- ClinicalTrials.gov ID
- NCT05359484
- Acronym / sponsor ID
- K22/2019
- Conditions
- Urinary Obstruction, Detrusor Underactivity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Usage of Uroflowmetry to distinguish between bladder outlet obstruction and detrusor hypo-contractility
| Arm | Type | Receives |
|---|---|---|
| detrusor underactivity | Experimental | Diagnostic Test: Uroflowmetryaccording 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. |
| bladder out flow obstruction | Experimental | Diagnostic Test: Uroflowmetryaccording 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uroflowmetryaccording 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. | Diagnostic test | bladder out flow obstruction, detrusor underactivity |
Primary outcome
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
3 secondary outcomes
Q max
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Q Average
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
post voiding residual urine
Time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Uroflowmetry in people with Urinary Obstruction and Detrusor Underactivity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Q average (time frame: preoperative test, it is done only once and comparative evaluation with other parameters will be done). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.