Evaluation of Efficacy and Safety of Midurethral Slings in Women With Stress Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pressure-volume study
研究概览
简要总结
The trans-obturator tape (TOT), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (SUI) patients. Nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the TOT-enhanced outlet resistance has not been adequately investigated. This study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the TOT surgery.
详细描述
The urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline similar to body temperature at an infusion rate of 80 ml/min. All patients received a pre- and a post-operative urodynamic evaluation, in which pre-operative evaluation was conducted 1-4 weeks before TOT procedure, and post-operative evaluation was done at 4-6 weeks follow-up.
Complete multichannel urodynamic studies including free uroflowmetry, filling and voiding cystometry, and urethral pressure profile was performed in each patient. The urodynamic parameters measured were the maximum flow rate (Qmax), voided volume, post-void residual volume (PVR), and detrusor pressure at Qmax (Pdet. Qmax). The filling cystometry and urethral pressure profile were performed with 37 degrees C normal saline at an infusion rate of 80 ml/min. All data were recorded and analyzed using a Medical Measurement Systems (MMS UD-200, Enschede, The Netherlands). All data in this study will be expressed as mean ± SEM. After checking the normality and variance of data, two-way ANOVAs were used to assess the difference in values among testing groups and time points; and post hoc Student-Newman-Keuls tests were used to compare the means of groups when there was a significant difference between groups. Significance was set at p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stress urinary incontience
- •Have urodynamic investigations before and after operation.
排除标准
- •Exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or (3) other medical (such as diabetes or inflammation) problems as well as (4) patients who received a concomitant surgical procedure.
研究组 & 干预措施
Before TOT
Data obtained before the operation
干预措施: Urodynamic investigations before and after a trans-obturator tape protocol. (Procedure)
After TOT
Data obtained after the operation
干预措施: Urodynamic investigations before and after a trans-obturator tape protocol. (Procedure)
Before TVT-O
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
After TVT-O
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
After Solyx sling
Data obtained before the operation
干预措施: Urodynamic investigations before and after an Solyx sling protocol. (Procedure)
Pre-menopausal patient before TVT-O
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Pre-menopausal patients after TVT-O
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Before i-STOP
Data obtained before the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
After i-STOP
Data obtained after the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Aged patient (>50 y/o) before TVT-O
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Aged patient (>50 y/o) after TVT-O
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Young patients (<50 y/o) before TVT-O
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Young patients (<50 y/o) after TVT-O
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Menopausal patient before TVT-O
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Menopausal patient after TVT-O
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a tension-free vaginal tape-obturator (TVT-O) (Procedure)
Aged patient before i-STOP
Data obtained before the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Aged patient after i-STOP
Data obtained after the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Young patient before i-STOP
Data obtained before the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Young patient after i-STOP
Data obtained after the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Menopausal patient before i-STOP
Data obtained before the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Menopausal patient after i-STOP
Data obtained after the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Pre-menopausal patient before i-STOP
Data obtained before the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Pre-menopausal patient after i-STOP
Data obtained after the operation.
干预措施: Urodynamic investigations before and after an i-STOP mini adjustable sling protocol. (Procedure)
Before mini Arc
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
After mini Arc
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Age patient before mini Arc
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Age patient after mini Arc
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Young before mini Arc
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Young patient after mini Arc
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Menopausal patient before mini Arc
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Menopausal patient after mini Arc
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Pre-menopausal before mini Arc
Data obtained before the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Pre-menopausal patient after mini Arc
Data obtained after the operation.
干预措施: Urodynamic investigations before and after a mini Arc protocol. (Procedure)
Before Solyx sling
Data obtained before the operation
干预措施: Urodynamic investigations before and after an Solyx sling protocol. (Procedure)
结局指标
主要结局
Pressure-volume study
时间窗: within a voiding cycle (a cycle is about 30 to 60 minutes)
urine leakage.
次要结局
未报告次要终点
研究者
Chin-Tsung Shen
Head of administration
Mackay Medical College