Urodynamic Changes Following Bladder Injury
Uro-PAS
1 other identifier
observational
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedNovember 27, 2023
November 1, 2023
3.1 years
April 2, 2021
November 23, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Symptomatic group
These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms
Asymptomatic group
These patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms
Interventions
Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Ayman Shehata Dawood
Tanta, Algharbia, 31111, Egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 2, 2021
First Posted
April 8, 2021
Study Start
July 1, 2021
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
November 27, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 3 months
On request