The Advantage of Combined Non-ablative Erbium Yttrium Aluminum Garnet Laser and High Intensity Tesla Magnetic Stimulation for Treatment of Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Adverse events
研究概览
简要总结
To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)
详细描述
This study is a single-centre, two-arm randomized control trial study conducted according to Helsinki Declaration. Women with symptoms of stress urinary incontinence (SUI) (stress or mixed with stress incontinence as the predominant symptom) will be enrolled.
The efficacy and safety of combined treatment with non-ablative intravaginal Er:YAG laser procedure and high intensity Tesla magnetic stimulation will be compared to the treatment of non-ablative intravaginal Er:YAG laser alone.
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
- 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
- •Adult female, 18 years of age or older
- •Clinical diagnosis of stress or mixed urinary incontinence, with stress incontinence as the predominant symptom (SUI or MUI)
排除标准
- •Very severe urinary incontinence (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) ICIQ-UI )score at baseline >18 or Pad test > 50 gr)
- •Acute urinary tract infections (UTIs)
- •History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
- •Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
- •Prolapse grade 2 or higher
- •History of radiotherapy for cervical or uterine cancer
- •Medical condition that may interfere with participants' compliance to the protocol
- •Medical condition for which the HITS and laser therapy are contraindicated
- •Previous laser or HITS treatment for SUI
结局指标
主要结局
Adverse events
时间窗: up to 6 month post procedure
The number and severity of treatment-related Adverse Events.
Symptoms of stress urinary incontinence
时间窗: measured at 3 and 6 months
Change of symptoms of stress and/or mixed urinary incontinence as measured by change in one hour pad test (gr/h) results at the end of treatment period from the baseline results.
次要结局
- PGI-I - Patient Global Impression of Improvement(measured at 3 and 6 months)
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(measured at 3 and 6 months)
- QUID - Questionnaire for Urinary Incontinence Diagnosis(measured at 3 and 6 months)
- FSFI - The Female Sexual Function Index(measured at 3 and 6 months)
- One-hour pad test.(measured at 3 and 6 months)
研究者
Barry O'Reilly
Head of Urogynecology department
Cork University Maternity Hospital