Urodynamic Changes Following Bladder Injury (Uro-PAS)

Tanta University

Status: Enrolling

Conditions: Urologic Injuries; Urodynamic Changes; Bladder Dysfunction

Treatments: Diagnostic Test: Urodynamic study

Study type: Observational

Funder types: Other

Identifiers

NCT04835766

Uro-PAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Symptomatic group

Description:

These patients had bladder injury during PAS surgery and had Lower urinary tract symptoms

Treatment:

Diagnostic Test: Urodynamic study

Asymptomatic group

Description:

These patients had bladder injury during PAS surgery and had no Lower urinary tract symptoms

Treatment:

Diagnostic Test: Urodynamic study