Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2021-07-01
2024-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic group
These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms
Urodynamic study
Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).
Asymptomatic group
These patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms
Urodynamic study
Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).
Interventions
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Urodynamic study
Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).
Eligibility Criteria
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Inclusion Criteria
* Placenta accreta managed either by cesarean hysterectomy or by uterine sparing conservative treatment
* Bladder injury was diagnosed and repaired during surgery 6 months ago.
Exclusion Criteria
* Presence of congenital urinary system anomalies
* Urinary tract infections (UTIs)
* Previous urologic surgeries
* Patients with stone bladder or tumour
* Diabetic patients
20 Years
40 Years
FEMALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ayman S Dawood, MD
Assistant professor
Locations
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Ayman Shehata Dawood
Tanta, Algharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Uro-PAS
Identifier Type: -
Identifier Source: org_study_id