Intraurethral Laser Therapy for Stress Urinary Incontinence: A Randomized Sham - Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Subjective symptoms of SUI
研究概览
简要总结
Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.
详细描述
Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.
Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.
Design: randomized double blinded sham - controlled clinical study
Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.
Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.
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
- Double (Participant, Care Provider)
盲法说明
Eligible patients will receive written and oral information about the study. After informed consent patients will be randomized into the intraurethral laser treatment group or sham laser group using the internet based program "randomizer", at a 1.1 ratio without stratification. Patients and the person performing the laser treatment will not aware of the treatment given. The laser devices can be used as a placebo laser blocking the laser beam with a plug.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female between 18 and 80 years
- •Confirmed SUI through cough stress test within the last 24 months
- •SUI I-II° for more than 6 months
- •At least one incontinence episode per 24 hour period measured over three days according to a bladder diary
- •Valsalva leak-point pressure (VLPP) ≤60 cm H2O
- •Maximum cystometric capacity ≥250 mL
- •No pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent SUI following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit)
- •BMI (body mass index) ≤35 kg/m2
- •Willing to give informed consent and complete the follow up schedule
排除标准
- •Active lower urinary tract infections (urethritis, cystitis or vaginitis)
- •Three (3) or more cultured-proven bacterial urinary tract infection (UTI) in the last 12 months
- •Detrusor overactivity on urodynamics
- •Postvoiding residual (PVR) > 100 ml
- •Previous urethral surgery (i.e. fistula or diverticula)
- •Pelvic organ prolapse grade > 3 as defined by POP-Q and symptomatic
- •Known polyuria (>3l/24h)
- •Unevaluated macro hematuria
- •Neurogenic bladder
- •Evidence of dysplasia in a Pap smear (done in the last 24 months)
- •Tumours of the Urinary tract
- •Previous radiation or brachytherapy to treat pelvic cancer
- •Uncontrolled diabetes
- •Active herpes genitalis
- •Pregnancy
- •Vaginal delivery within 6 months prior to the Screening/Baseline Visit
结局指标
主要结局
Subjective symptoms of SUI
时间窗: 3 months
A visual analogue scale (VAS) is used for assessment for the subjective symptoms and improvement of SUI. Patients are asked to indicate the degree of their symptoms on a scle ranging from 0 (no symptoms) to 10 (worst possible symptoms).
次要结局
- Patient satisfaction with treatment/inpatient management(3 months)
- Objective SUI(3 months)
- Patient Global Impression of Improvement(3 months)
- Patient Global Impression of Severity(3 months)
- Pad Weight(3 months)
- Degree of pain during laser therapy on a visual analogue scale (VAS)(3 months)
- Subjective SUI(3 months)
- Quality of Life using the Kings Health Questionnaire(3 months)
- Pelvic floor symptoms(3 months)
- Microbiome(3 months)