The Treatment of Stress Urinary Incontinence Using an Incontinence Ring: A Randomized, Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week
研究概览
简要总结
This study aims as defining success rate of the incontinence ring in women with test proven stress urinary incontinence and determining factors associated with successful use.
详细描述
The primary objective of this study is to determine if the incontinence ring is effective in decreasing the incontinence episode frequency per week. Other objectives include the determination of the cure rate (objective and subjective) with the ring, the effects to bladder function as noted on urodynamic testing, the impact on quality of life and the acceptability to this device in the treatment of stress urinary incontinence.
In this cross-over study, 40 women will undergo a two-period treatment. In one of the periods, she will spend 4 weeks wearing continuously the ring and in the other (also 4 weeks duration), she will not be using any treatment for her incontinence. Between periods, she will spend 2 weeks in "wash out" to eliminate the risk of continuous effect from the treatment in the preceding period. Each woman will be randomly assigned to the treatment sequence.
Stress urinary incontinence is a common problem affecting at almost 20% of women. Treatments currently advocated include pelvic floor exercises and surgery. Pelvic floor exercises require great motivation and usually 3 months of training to show an impact. Surgery is very effective, but costly and carries a number of complications. The use of the incontinence ring may allow women to control their symptoms with immediate result at minimal risk. This device has never been properly evaluated before its introduction into the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Symptoms of urinary stress urinary incontinence (i.e. urinary leakage associated with increased intra-abdominal pressure/cough) (if mixed incontinence the urinary stress urinary incontinence symptoms must predominate)
- •Urodynamic Stress urinary incontinence confirmed by urodynamic studies (i.e. urinary leakage associated with increased intra-abdominal pressure/cough in the absence of detrusor overactivity)
- •Ability to understand spoken and written English
排除标准
- •Severe pelvic organ prolapse (> or = stage 3 on the Pelvic Organ Prolapse Quantification System - POP-Q)
- •Contraindications to pessary use (including acute vaginal/urinary or pelvic infections, vaginal or cervical lesions or unexplained vaginal bleeding)
- •Inability to properly fit the incontinence ring
结局指标
主要结局
Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week
时间窗: baseline and 4 weeks
number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.
次要结局
- Objective Cure Rate(4 weeks)
- Patient Acceptability (10 cm VAS)(4 weeks)
- Post Void Residual(The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of "no treatment" UDS.)
- Score on Question 3 of UDI 6(4 weeks)
- UDI Overall Score(4 weeks)
- Urodynamic Effect of the Incontinence Ring on Flow Rate(baseline and at 4 weeks of ring use.)
- Impact on I-QOL(4 weeks)
研究者
Dr. Marie-Andree Harvey
Principal Investigator
Queen's University