Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary outcome is the subjective success rate (cure or improvement) of SUI
研究概览
简要总结
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).
Women with symptomatic stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm.
There are 3 visits (with a maximum of 6 visits) where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
The primary objective is to evaluate the effects of VEL treatment for the subjective cure or improvement of SUI.
The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.
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 (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS). Scores are from 0 to
- •The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
- •Voluntary informed consent
排除标准
- •Any previous PFE-treatment in the last year for the same problem
- •Previous surgery for incontinence or prolapse
- •Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
- •Prolapse grade III or more
- •Pregnancy
- •Vaginal bleeding, injuries or infection in the treated area
结局指标
主要结局
Primary outcome is the subjective success rate (cure or improvement) of SUI
时间窗: 4 months after randomisation
The tool used is the UDI-6 questionnaire. Converted UDI-6 scores range between 0 and 300. The "minimum important difference" is defined as a (MID)=11. In that score, cure is defined as answering "No" (0) to the question "Do you experience urine leakage related to physical activity, coughing or sneezing?".
次要结局
- Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)(At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment)
- Assessment of sexual function(At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment)
- Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).(At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment)
- Assessment of the objective success rate by means of the cough stress test (CST).(At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment)
- Assessment of the degree of discomfort of the treatment procedure by the patient(At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment)
- Assessment of the longevity of the effect of laser therapy(At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment)
- Assessment of treatment compliance in the PFE-group(At end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatmentAt every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24)
研究者
prof. dr. Jan Deprest
MD, PhD
Universitaire Ziekenhuizen KU Leuven