Urodynamic Changes Following Bladder Injury

Bladder Dysfunction Clinical Trial

— Uro-PAS  

Official title:

Urodynamic Changes Following Bladder Injury During Surgical Management of Placenta Accreta Spectrum: A Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835766
• Other study ID #: Uro-PAS
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Ayman Dawoog, MD
• Phone: +202020972067
• Email: ayman.dawood[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bladder Dysfunction
• Urodynamic Changes
• Urologic Injuries
• Wounds and Injuries

Intervention

Diagnostic Test:
• Urodynamic study
Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder dysfunction	Uroflowmerty measuring the flow of urine in ml per minute	6 months
Primary	Residual urine volume	Assessed by ultrasound to measure volume of residual urine	6 months
Primary	maximum flow rate	Urodynamic study	6 months
Primary	Detrusor pressure at maximum flow	Urodynamic study	6 months