Laser Vaginal Treatment for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- SUI cure
研究概览
简要总结
RCT designed to answer the question:
Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?
详细描述
This is a double blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm followed by an open label trial at 6 months for any sham treatment arm participants who do not meet treatment success.
The primary goal is to compare the subjective success rates for the resolution of UI for the vaginal laser treatment at 6 months. Secondary aims include an assessment of complications, resolution of SUI symptoms (objective and subjective measures), patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 182 patients. At the 6-month post treatment evaluation, the treatment allocation will be unmasked. The trial will be of approximately 3 years in duration (1 year to recruit and 2 years for follow up).
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)
盲法说明
only the care provider (who is not involved with recruitment or evaluation of patients' outcomes) will be aware of the treatment assignments
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
- •Female patient, aged 18 years or older at the time of enrollment,
- •primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation; for a duration of at least 3 months (patient can be rescreened after this time interval has passed).
- •The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it.
- •objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc
- •Bladder capacity ≥200cc
- •Post void residual ≤100cc with Stage I or lower pelvic organ prolapse
排除标准
- •Patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is <12 months post partum
- •Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula)
- •Patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum
- •Current chemo/ radiotherapy; history of pelvic radiation
- •Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury)
- •Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms
- •History of synthetic sling
- •Pelvic surgery < 3 months
- •Current evaluation or treatment for chronic pelvic pain
- •Patient has pelvic organ/ vaginal prolapse extending to or out of the vaginal opening
- •Participation in another treatment intervention that might interfere with the results of this trial
- •Patient has a medical condition or disorder that may limit life expectancy or that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, urinary symptoms, and/or data).
- •Patient has ambulatory 24 hour pad test, where the increased pad weight is < 3 grams.
- •Patient is non-ambulatory (ambulatory with assistive devices allowed)
研究组 & 干预措施
laser treatment
Erbium-YAG laser treatment to the vagina
干预措施: Erbium-YAG laser vaginal treatment (Procedure)
sham treatment
sham treatment with laser placebo
干预措施: Erbium-YAG laser vaginal treatment (Procedure)
结局指标
主要结局
SUI cure
时间窗: 6 months post treatment
ICIQ questionnaire: The International Consultation on Incontinence Questionnaire (ICIQ) is a subjective measure of the severity of urinary loss and quality of life for those with incontinence. With the short form, there are 3 questions with a multi-choice selection of responses with each response having an assigned score. The total score (additive from the 3 questions) are between 0 - 21. Higher scores are indicative of greater severity.
次要结局
- Adverse effects(6,12 24 months post treatment)