Could Urinary Bladder Hypertrophy Influence on Urge Urine Incontinence Development in Patients After Radical Prostatectomy: A Multi-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- Increased incidence OAB - Ultrasonography of bladder wall
研究概览
简要总结
This study is designed to evaluate men before radical prostatectomy for the incidence of Overactive Bladder (OAB), as well as urge urine incontinence (UUI) development after the surgery. Patients will be evaluated for signs of OAB and for signs of Bladder Outlet Obstruction (BOO). Afterwards they will be divided into four observational groups. Follow up period is designed to be 12 months.
详细描述
Radical prostatectomy remains the standard treatment in case of organ-confined and in selected cases of locally advanced prostate cancer. Radical prostatectomy consists of removing the prostate gland and seminal vesicles, ideally with negative surgical margins.
Most of the patients who present urinary incontinence after radical prostatectomy have stress urinary incontinence. However in some cases the post-surgical urinary incontinence is also due to urgency caused by overactive bladder development defined as urge urinary incontinence. Recent clinical observations suggest that men can also develop overactive bladder after radical prostatectomy.
This study is designed to evaluate men before radical prostatectomy for the incidence of Overactive Bladder (OAB) and it's development after the surgery. Before surgery questionnaire assessment of lower urinary tract symptoms will be performed using International Prostate Symptom Score (IPSS) questionnaire. OAB symptoms will be analyzed using King's questionnaire, as well as using two different OAB symptom score (OABSS) designed by Blavis et al. and Homma et al. Each patient will have transabdominal ultrasonographic evaluation of the prostate and urinary bladder structure. Prostatic dimensions width (W), height (H), length (L) and volume will be recorded. The ultrasonography will be done in urinary bladder filling related to normal desire to void. Urinary bladder wall thickness (BWT) and detrusor muscle thickness (DWT) will be measured in sagittal plane in anterior bladder wall. The mean of three following measurements BWT and DWT will be obtained. The urinary bladder weight (UEBW: Ultrasound Estimated Bladder Weight) will be also estimated. After ultrasonography each patient will undergo uroflowmetry with post-void residual estimation.
On the results above 4 groups will be formed
Group 1 OAB (-) BOO (-)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult men over 40 years old with prostate cancer qualified for radical prostatectomy
- •Control group formed from 20 healthy men aged 20-40 years old without any urological conditions and no lower urinary tract symptoms (LUTS).
排除标准
- •Neoadjuvant (any time before) or adjuvant radiotherapy or brachytherapy (within the follow-up period of 12 months).
- •Macroscopic infiltration of the bladder (pT4).
- •Neurological deficiencies, such as stroke, spinal cord injury, multiple sclerosis etc. causing inability to have any control of the bladder.
- •Urethral strictures.
- •Transurethral resection of the prostate or Adenomectomy performed within 12 months prior to Radical Prostatectomy.
- •Any form of constant catheterisation (indwelling catheter, clean intermittent catheterisation).
结局指标
主要结局
Increased incidence OAB - Ultrasonography of bladder wall
时间窗: 12 months
Measuring the incidence of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by increased urinary wall thickness (changes of urinary bladder wall in ultrasound evaluation measured in sagittal section in millimeters). Measurement: Bladder wall thickness, Detrusor Muscle thickness on each follow up visit.
Increased incidence OAB - Questioners
时间窗: 12 months
Measuring the incidence of symptoms of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by changes found in OABSS survey (Questioners). Measurement: OABSS survey on each follow up visit.
次要结局
- Continence(12 months)
- Qmax-Uroflowmetry(12 months.)
- Bladder volume during normal desire.(12 months)
- Quality of life.(12 months)
- Quality of urination.(12 months)
- Increased incidence OAB - Ultrasonography - Calculated Bladder weight(12 months)
研究者
Tomasz Drewa
Prof. dr hab. n. med.
Collegium Medicum w Bydgoszczy