ChiCTR1900021044进行中（未招募）治疗新技术临床试验
激光療法用於處理華人婦女壓力性小便失禁問題之隨機研究
Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 1990年1月1日最近更新:
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Reduction in PFDI Urinary Distress Inventory Stress Subscale scores between both groups
研究概览
简要总结
To compare the efficacy of vaginal laser treatment for women with SUI as compared to control, based on reduction in scores on health related quality of life (PFDI-UDI Stress Subscale), subjective outcome of symptoms improvement, urinary diary, VAS, other scores of health related quality of life.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Single
入排标准
- 性别
- Female
入选标准
- •Women aged over 18 years;
- •Patients diagnosed with urodynamic stress incontinence (USI);
- •Willing to give written consent and compliance to participate in the study.
排除标准
- •Patients with mixed urinary incontinence with predominant urge urinary incontinence;
- •Patients who had recurrent USI that failed previous surgical treatment, e.g. tension free vaginal tape surgery or injection of bulking agent;
- •Patients with pregnancy or lactating;
- •Patients with stage II or above pelvic organ prolapse;
- •Patients with undiagnosed vaginal bleeding, injury or active infection;
- •Patients currently in-use of photosensitive drugs;
- •Patients refuse to participate in the study.
研究组 & 干预措施
Two groups
Laser therapy with two phases 20 minutes 2 times with 4 weeks apart versus Sham procedure with zero intensity settings 20 minutes 2 times with 4 weeks apart
结局指标
主要结局
Reduction in PFDI Urinary Distress Inventory Stress Subscale scores between both groups
时间窗: At 6 and 12 months follow up after intervention
次要结局
- Symptoms of SUI according to question 20-22 of PFDI(At first visit, 6 and 12 months follow up after intervention)
- Symptoms of SUI according to the 3 days bladder diary(At first visit, 6 and 12 months follow up after intervention)
- Visual Analog Scale (VAS)(At first visit, 6 and 12 months follow up after intervention)
- Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups(At 6 and 12 months follow up after intervention)
- Anal tone and pelvic floor muscle strength by Oxford scale(At baseline, 6 and 12 months follow up after intervention)
- Need for surgical treatment for stress urinary incontinence(At 6 and 12 months follow up after intervention)
- Reduction in other domains of PFDI and PFIQ(At 6 and 12 months follow up after intervention)
- Reduction in ICIQ-UI SF score(At 6 and 12 months follow up after intervention)
- Tolerabilityof intravaginal laser treatment(After laser treatment/sham procedure.)
- Satifactory of intravaginal laser treatment(At 4 week, 3, 6 and 12 months follow up after intervention)
- Complications or adverse effect of intravaginal laser treatments(During and after laser treatment/sham procedure, at 6 and 12 months follow up after intervention)
研究者
研究点 (1)
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