ACTRN12624000458538尚未招募Unknown
Investigating the effect of Er-YAG Surgical Laser on Stress Urinary Incontinence symptoms in adult women – a randomised control trial.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Adult Female, 18 years of age or older
- •Slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women.
- •No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
- •Capable of providing informed consent and able to return for follow-up.
- •Normal Cervical screening test within last five years
排除标准
- •Very severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women.
- •Diagnosis of OAB wet, based on UDI-6, question 2 urine leakage related to the feeling of urgency” – answer Moderately OR Greatly”.
- •Presence of vesicovaginal fistula
- •Fecal incontinence
- •Pregnant subjects or women less than 12-months post-partum
- •Actively breastfeeding or ceased breastfeeding less than three menstrual cycles
- •Any previous prolapse surgery
- •Any previous incontinence surgery
- •Any radical pelvic surgery
- •Transvaginal mesh or sling implant
- •Pre-existing bladder pathology including prior radiation treatment.
- •Previous surgery in the treatment area in the last year.
- •Active genital infection
- •Subject presenting with a cervical screening test demonstrating cervical dysplasia or another reason for colposcopic assessment
- •Systemic steroids use within the last 3 months
- •Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system
- •Diagnosis of collagen disorders eg. Benign joint hypermobility/Ehlers-Danlos/Marfan etc.
- •Serious systemic disease or any chronic condition that could interfere with study compliance.
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
- •Other contraindications to laser treatment: UTI, injury or bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder or use of photosensitivity medications, abnormal scarring, excessive sun exposure, preoperative histology findings indicative of malignancy.
- •Unwillingness or inability to complete follow-up schedule
- •Unwillingness or inability to give Informed Consent
研究者
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