Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Pad weight test.
研究概览
简要总结
The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.
详细描述
Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.
Further demographic information and patient history will be obtained from the subjects' electronical files.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Negative urine culture.
- •Positive cough test.
- •Normal Papanicolaou (PAP) test from the past 3 years.
排除标准
- •signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence.
- •Overactive bladder.
- •Previous bulking injections.
- •Previous transvaginal mesh implant.
- •Previous surgery for stress urinary incontinence.
- •Presence of pelvic organ prolapse.
- •Presence of an active or recurring genital infection or urinary tract infection.
- •Previous laser-based or other energy-based treatments for gynecological indications.
- •Vaginal bleeding of unknown reason.
- •Pregnancy.
- •Current pelvic floor physiotherapy.
- •Current treatment with local or systemic hormone replacement therapy.
结局指标
主要结局
Pad weight test.
时间窗: 15 months from recruitment.
Pad weight results in grams.
次要结局
- International Consultation of Incontinence questionnaire.(15 months from recruitment.)
- Cough test(15 months from recruitment.)
- Visual analogue scale.(15 months from recruitment.)
- Urinary distress index 6 questionnaire.(15 months from recruitment.)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.(15 months from recruitment.)
研究者
ROY LAUTERBACH MD
Dr. Roy Lauterbach
Rambam Health Care Campus