Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pelvic Organ Prolapse Quantification System (POP-Q)
研究概览
简要总结
Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage >1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.
详细描述
Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Symptomatic prolapse stage >1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
- •Negative Pap-smear
排除标准
- •Asymptomatic prolapse
- •prolapse stage <=1
- •prolapse of uterus
- •presence of any type of genital infections (i.e herpes, vaginitis etc)
- •vaginal bleeding
- •underlying pathologies that could interfere in patients compliance (i.e psychiatric)
研究组 & 干预措施
Laser
Erbium Yttrium Aluminum Garnet (Er:YAG) laser therapies
干预措施: Erbium Yttrium Aluminum Garnet (Er:YAG) laser (Device)
Control
No intervention
结局指标
主要结局
Pelvic Organ Prolapse Quantification System (POP-Q)
时间窗: Change from baseline to 4-6 months
Physical examination
次要结局
- International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)(Change from baseline to 4-6 months)
- Pelvic Floor Distress Inventory Short Form (PFDI)(Change from baseline το 4-6 months)
- Pelvic Floor Impact Questionnaire short Form(Change from baseline to 4-6 months)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form(Change from baseline to 4-6 months)
- Patients Global Impression of Improvement(4-6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 3 months post-treatment)
研究者
Themos Grigoriadis
Assistant Professor
National and Kapodistrian University of Athens