Are Unsatisfying Results After TVT and TOT Operations Associated With Increased Urethral Mobility
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Subjective Success of Sling Operations
研究概览
简要总结
Main objective is to evaluate the relation between the increased urethral mobility and unsuccessful treatment after TVT and TOT operations.
140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses.Female patients of 25 to 70 years of age who are positive for stress test will be included.
All patients will be questioned for parity, body mass index, menopausal state, medical history, and examined for POP-Q stage, urodynamy, stress test, UDI 6, IIQ7 and with transperineal sonography preoperatively. "Passive mobility angle" and "active mobility angle" will be measured.
The relationship between passive mobility angle or active mobility angle and success of sling operations will be determined in this study.
详细描述
Transperineal sonography will be performed in a 300 cc filled bladder state, on a horizon which connects the lower margin of the pubic bone and the lower side of the urethral part of the bladder. First measurement will be done on litotomy position in resting state, second on 45 degrees reverse trandelenburg position in resting state and third one on 45 degrees reverse trandelenburg position in maximal valsalva straining state. The alteration between the angles measured at resting litotomy position and the resting reverse trandelenburg position is named as "passive mobility angle" (trigger gap) and the angle measured between the trigger gap and maximal valsalva state is named as "active mobility angle". Furthermore, post voiding residues have also been measured by transperineal ultrasonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •140 patients will be included in the research who are planned to have TVT and TOT operations with SUI and MUI diagnoses between March 1, 2013 and January 1, 2015 in Kanuni Sultan Suleyman Medical Research and Educational Hospital.
排除标准
- •Patients with level 3 or higher level of uterine descensus, previous urinary incontinence surgery, overactive bladder and who are unwilling for randomization will not been included.
研究组 & 干预措施
Urinary incontience surgery
Patients who is between 25 to 70 years old and positive stress test and have TVT or TOT operations with diagnoses of stress urinary incontinence and mixed urinary incontinence .
干预措施: Urinary incontience surgery (Procedure)
Urinary incontience surgery
Patients who is between 25 to 70 years old and positive stress test and have TVT or TOT operations with diagnoses of stress urinary incontinence and mixed urinary incontinence .
干预措施: 300 cc saline (Drug)
结局指标
主要结局
Subjective Success of Sling Operations
时间窗: 6 months
Patients whose postoperative UDI-6 and IIQ-7 scores lower than 10 will described as success of sling operations
次要结局
- Objective Success of Sling Operations(6 months)
研究者
Agahan Han,MD
MD
Kanuni Sultan Suleyman Training and Research Hospital