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临床试验/NCT04835766
NCT04835766招募中不适用

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

Tanta University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman S Dawood, MD

Assistant professor

Tanta University

研究点 (1)

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