Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).
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 prolapse (grade II-IV) who seek for a conservative treatment, with no history of previous POP-surgery will be randomised to either the laser-arm or the PFE-arm.
There are 3 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 reduction of prolapse symptoms and as a secondary outcome objective measurements. These endpoints are in line with the recommendations by Durnea et al., as being the most relevant and patient centered outcomes.
The second goals are to register adverse events and to determine for how long the effects of laser are sustained, with a maximum of two years. To do so, the investigators will measure long term satisfaction with, and the longevity of the effect (measured by the need for repeat or alternative therapy) of laser therapy.
Duration of follow-up per patient: max 27 months
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
- •The presence of POP symptoms
- •Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)
- •Voluntary informed consent
排除标准
- •Symptoms or anatomical evidence for intussusception / rectal prolapse
- •Leading descent of the middle compartment (C > Ba/Bp)
- •Grade IV prolapse
- •Previous POP surgery
- •Pregnancy or <12 months postpartum
- •Vaginal bleeding, injuries or infection in the treated area
结局指标
主要结局
Primary outcome is the subjective improvement of POP symptoms, assessed by the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).
时间窗: 6 months after last treatment
Participants have to answer 6 questions concerning POP symptoms with a response scale from 0 to 4 (not present (=0), not at all (=1), somewhat (=2), moderately (=3), quite a bit (=4)). The score (range 0 to 100) is then obtained by multiplying the mean value of all of the answered items by 25. Missing items are dealt with by using the mean from answered items only. Higher scores indicate more distress. This questionnaire is available and validated in English, Dutch and French. Success is defined as a reduction in scores of at least 25% compared with baseline.
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, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment)
- Assessment of the anatomical success rate by means of the POP-Q system(At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 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 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, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment)
- Assessment of urinary symptoms by means of the Urogenital Distress Inventory (UDI-6)(At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment)
- Assessment of sexual function, by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR)(At every visit (ie. week 4, 8 and 12, optional: 16, 20 and 24 weeks), 6, 12 and 24 months after end of treatment)
研究者
prof. dr. Jan Deprest
MD, PhD
Universitaire Ziekenhuizen KU Leuven