Urodynamic Changes Following Bladder Injury During Surgical Management of Placenta Accreta Spectrum: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Detrusor pressure at maximum flow
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Detrusor pressure at maximum flow
时间窗: 6 months
Urodynamic study
Residual urine volume
时间窗: 6 months
Assessed by ultrasound to measure volume of residual urine
Bladder dysfunction
时间窗: 6 months
Uroflowmerty measuring the flow of urine in ml per minute
maximum flow rate
时间窗: 6 months
Urodynamic study
次要结局
未报告次要终点
研究者
Ayman S Dawood, MD
Assistant professor
Tanta University
