3-year Follow up of Patients With Stress Urinary Incontinence Treated With Minimally Invasive Er: YAG Laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 主要终点
- Assessment of 1 hour pad weight test
研究概览
简要总结
Study is designed to assess the long-term clinical effects and safety profile of non-ablative Er:YAG (IncontiLase®) laser treatment, the durability of the results and the optimal treatment regimen for mild-to-severe stages of genuine female stress urinary incontinence (SUI).
详细描述
All patients with urodynamically proven SUI, who have failed/declined conservative therapies will be informed about the study.
They will be invited to attend a screening/baseline visit. At this visit, they will be asked to perform a standardised 1 hour pad test. Their medical history will be checked and they will undergo a clinical and vaginal examination, pregnancy test and dip stick urinalysis. If their 1 hour pad weight is >2g and they meet all other inclusion / exclusion criteria, they will be eligible for inclusion. They will receive detailed instructions for performing a 24 hour pad test, and will be asked to keep a 3 day voiding diary. They will be given the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF).
Patients will then undergo 3 outpatient treatment visits. The timing of visits will be approximately 1 month apart. At each of their 3 outpatient appointments, they will be asked about any deleterious effects since their last appointment. Patients will receive 3 treatments in total.
Patients will be invited to attend a follow-up visits 3, 6, 12 and 18 months after the 3rd treatment and asked to complete the 1 hour pad test, 24 hour pad test, 3 day voiding diary and ICIQ-SF questionnaire.
At the 18-, 24- and 30-month follow up, they will be given an option to receive additional single session of non-ablative Er:YAG laser treatment. At each visit, and during additional visit after 36 months, they will be asked to complete all of the tests (1 hour pad test, 24 h hour pad test, 3 day voiding diary and ICIQ-UI SF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Adult Female, 18 years of age or older
- •Clinical and urodynamic study (UDS) diagnosis of Stress Urinary Incontinence
- •No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
排除标准
- •Pre-existing bladder pathology including prior radiation treatment
- •Pregnancy
- •Radical pelvic surgery or previous incontinence surgery
- •Urinary tract infection or other active infections of urinary tract or bladder
- •SUI III (VLPP > 60 cm H2O)
- •Any form of pelvic organ prolapse (POP) stage 2 or greater, according to POP-Q
- •Diagnosis of urge incontinence
- •Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
- •Incomplete bladder emptying
- •Vesicovaginal fistula
- •Faecal incontinence
- •Unwillingness or inability to complete follow-up schedule
- •Unwillingness or inability to give Informed Consent
- •Failure to comply with diary requirements during extended baseline period
结局指标
主要结局
Assessment of 1 hour pad weight test
时间窗: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
The change in standardised 1 hour pad weight test from baseline to 36 months following treatment schedule.
Assessment of ICIQ-UI SF scores
时间窗: Baseline, 3, 6, 12, 18, 24, 30 and 36 months
Change in mean test scores range = 0 - 21; low score = mild symptoms, high score = significant impact on quality of life.
次要结局
- Change in leakage frequency as assessed by 3 day voiding diary(Baseline, 3, 6, 12, 18, 24, 30 and 36 months)
- Change in 24 hour pad weight test(Baseline, 3, 6, 12, 18, 24, 30 and 36 months)
研究者
Adrian Gaspar
Principal Investigator
Espacio Gaspar Clinic