Urologic InjuriesUro-PASNCT04835766
Urodynamic Changes Following Bladder Injury
An observational study of Urologic Injuries and Urodynamic Changes, run by Tanta University at 1 site in Egypt.
Trial summary
This study is a unique one as it si done for first time to all patients following bladder injury in PAS surgery. Bladder function will be assessed by urodynamic study. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Urologic Injuries, Urodynamic Changes, Bladder Dysfunction
- What is being tested?
- Urodynamic study
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 31 Jul 2024
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Adult
Study population: This study is multi-center descriptive cohort study. This study will be conducted at Urology departments. Cases were recruited from both Obstetrics and gynecology and Urology departments of Al-Azhar University and Tanta University. All cases had past history of bladder injury during PAS surgery either by hysterectomy or uterine sparing techniques.
Who may be able to join
- Age 20-40 years
- Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment
- Bladder injury was diagnosed and repaired during surgery 6 months ago.
Who cannot join
- Patients with neurological problems
- Presence of congenital urinary system anomalies
- Urinary tract infections (UTIs)
- Previous urologic surgeries
- Patients with stone bladder or tumour
- Diabetic patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ayman Shehata Dawood
Tanta, Algharbia, 31111
Salah Zeidan, MD, +201020972067, salahshebl@gmail.com
Ayman Dawood, MD, +201020972067, ayman.dawood@med.tanta.edu.eg
About this study
Official title: Urodynamic Changes Following Bladder Injury During Surgical Management of Placenta Accreta Spectrum: A Multicenter Study
This study is a unique one as it si done for first time to all patients following bladder injury in PAS surgery. Bladder function will be assessed by urodynamic study.
Read the detailed description
Patients will be initially assessed by overactive bladder (OAB) and incontinence questionnaire. Examination was done to determine any neurological, or congenital abnormalities.
Urodynamic study (UDS) will done for all patients. The patients will be asked to drink fluids to obtain a comfortably full bladder. Initially, a pelvic-abdominal ultrasound was done followed by the UDS. Urodynamic study consisted of uroflowmetry (volume: ≥150 ml and Qmax: 20-30 ml/s); filling cystometry in physiological or medium filling rate of 40 ml/min (using normal saline at room temperature through a double lumen urethral catheter); stress leak test; and pressure flow study.
No sedation will be administered during the study as the patient should be aware. The patients were placed in a semi-seated lithotomy position. After a detailed explanation to the patient, the examination will begin by passing a catheter into the bladder (5 Fr) to measure the postvoiding residual urine followed by filling the bladder and measuring the intravesical pressure through the catheter.
A rectal catheter was placed for measuring the abdominal pressure. The systems will be always zeroed at the atmospheric pressure. The patients will be periodically asked to cough to check the operation of the equipment and instructed to report her sensations.
The volume of the first sensation of filling, first desire (1 s) and second desire (2 s) were recorded. When the bladder was filled up to 150 ml, patients were asked to cough (Valsalva) to predict the stress leakage. If not occur at 150 ml, the bladder was refilled, and the stress test was repeated until the leakage occurred or the bladder capacity was reached. Additionally, any unidentified involuntary detrusor contractions will be noted.
When the patient had the urge to void, the permission for voiding will be given. Then voiding cystometrogram (pressure-flow) was performed and the urodynamic parameters, such as maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax) will be observed.
- Conditions
- Urologic Injuries, Urodynamic Changes, Bladder Dysfunction
- Being tested
- Urodynamic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic studyDiagnostic test
Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic group | These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms Receives: Diagnostic Test: Urodynamic study | |
| Asymptomatic group | These patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms Receives: Diagnostic Test: Urodynamic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder dysfunction
Uroflowmerty measuring the flow of urine in ml per minute
Measured: 6 months
Residual urine volume
Assessed by ultrasound to measure volume of residual urine
Measured: 6 months
maximum flow rate
Urodynamic study
Measured: 6 months
Detrusor pressure at maximum flow
Urodynamic study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jul 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835766
- Sponsor's protocol ID
- Uro-PAS
- Acronym
- Uro-PAS
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamic Changes Following Bladder Injury During Surgical Management of Placenta Accreta Spectrum: A Multicenter Study
- ClinicalTrials.gov ID
- NCT04835766
- Acronym / sponsor ID
- Uro-PAS / Uro-PAS
- Conditions
- Urologic Injuries, Urodynamic Changes, Bladder Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 Apr 2021 (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.
This study is a unique one as it si done for first time to all patients following bladder injury in PAS surgery. Bladder function will be assessed by urodynamic study.
Detailed description
Patients will be initially assessed by overactive bladder (OAB) and incontinence questionnaire. Examination was done to determine any neurological, or congenital abnormalities.
Urodynamic study (UDS) will done for all patients. The patients will be asked to drink fluids to obtain a comfortably full bladder. Initially, a pelvic-abdominal ultrasound was done followed by the UDS. Urodynamic study consisted of uroflowmetry (volume: ≥150 ml and Qmax: 20-30 ml/s); filling cystometry in physiological or medium filling rate of 40 ml/min (using normal saline at room temperature through a double lumen urethral catheter); stress leak test; and pressure flow study.
No sedation will be administered during the study as the patient should be aware. The patients were placed in a semi-seated lithotomy position. After a detailed explanation to the patient, the examination will begin by passing a catheter into the bladder (5 Fr) to measure the postvoiding residual urine followed by filling the bladder and measuring the intravesical pressure through the catheter.
A rectal catheter was placed for measuring the abdominal pressure. The systems will be always zeroed at the atmospheric pressure. The patients will be periodically asked to cough to check the operation of the equipment and instructed to report her sensations.
The volume of the first sensation of filling, first desire (1 s) and second desire (2 s) were recorded. When the bladder was filled up to 150 ml, patients were asked to cough (Valsalva) to predict the stress leakage. If not occur at 150 ml, the bladder was refilled, and the stress test was repeated until the leakage occurred or the bladder capacity was reached. Additionally, any unidentified involuntary detrusor contractions will be noted.
When the patient had the urge to void, the permission for voiding will be given. Then voiding cystometrogram (pressure-flow) was performed and the urodynamic parameters, such as maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax) will be observed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic group | – | Diagnostic Test: Urodynamic studyThese patients had bladder injury during PAS surgery and had Lower urinary tract symptoms |
| Asymptomatic group | – | Diagnostic Test: Urodynamic studyThese patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This study is multi-center descriptive cohort study. This study will be conducted at Urology departments. Cases were recruited from both Obstetrics and gynecology and Urology departments of Al-Azhar University and Tanta University. All cases had past history of bladder injury during PAS surgery either by hysterectomy or uterine sparing techniques.
Key inclusion criteria (3 listed)
- Age 20-40 years
- Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment
- Bladder injury was diagnosed and repaired during surgery 6 months ago.
Key exclusion criteria (6 listed)
- Patients with neurological problems
- Presence of congenital urinary system anomalies
- Urinary tract infections (UTIs)
- Previous urologic surgeries
- Patients with stone bladder or tumour
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 |
|---|---|---|
| Urodynamic studyUroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax). | Diagnostic test | Asymptomatic group, Symptomatic group |
Primary outcome
Bladder dysfunction
Time frame: 6 months
Uroflowmerty measuring the flow of urine in ml per minute
Residual urine volume
Time frame: 6 months
Assessed by ultrasound to measure volume of residual urine
maximum flow rate
Time frame: 6 months
Urodynamic study
Detrusor pressure at maximum flow
Time frame: 6 months
Urodynamic study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Yes. On request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Injuries and Urodynamic Changes, run by Tanta 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Dawoog, MD (+202020972067, ayman.dawood@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder dysfunction (time frame: 6 months). The study lists 4 primary outcomes in all. 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 27 Nov 2023.