Urodynamic Changes Following Bladder Injury (Uro-PAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Injuries; Bladder Dysfunction; Urodynamic Changes
• Intervention / Treatment: Diagnostic test: 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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Ayman Dawood, MD; Phone Number: +201020972067; Email: ayman.dawood@med.tanta.edu.eg
• Study Contact Backup: Name: Ayman Dawoog, MD; Phone Number: +202020972067; Email: ayman.dawood@med.tanta.edu.eg

Study Locations

• Egypt
  • Algharbia
    • Tanta, Algharbia, Egypt, 31111
      • Recruiting
      • Ayman Shehata Dawood
      • Contact: Salah Zeidan, MD; Phone Number: +201020972067; Email: salahshebl@gmail.com
      • Contact: Ayman Dawood, MD; Phone Number: +201020972067; Email: ayman.dawood@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic group; These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms	Diagnostic test: 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	Diagnostic test: Urodynamic study; Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Uro-PAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request
• IPD Sharing Time Frame: 3 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No