NCT03916471Unknown不适用
Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up. Prospective, Randomized and Non-inferiority Study
Instituto de Investigacion Sanitaria La Fe1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2018年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Continence rate (Objective) assessed by an effort test
研究概览
简要总结
Boston2018 post-market clinical study is a prospective, randomized, non-inferiority study to assess the efficacy and adverse events of the Solyx™ Single Incision Sling (SIS) System compared to the gold-standard Obtryx™ II Sling System, in patients with stress urinary incontinence (SUI) and long-term follow-up (5 years).
详细描述
Randomized prospective non-inferiority study, in which we evaluate patients with stress urinary incontinence (SUI) who undergo surgical treatment consisting of a minimal incision in the suburethral area of the vaginal mucosa for a mesh insertion in order to:
Main Objective:
To compare the continence rate (objective) between Solyx and Obtryx II meshes in patients with SUI. This rate will be determined by an effort test.
Secondary Objectives:
- To compare the continence rate (subjective) between both meshes.
- To compare variations in Pad-Test.
- To asses patient satisfaction.
- To evaluate both techniques regarding quality and sexual life modifications.
- To compare both techniques regarding early complications (up to 30 days post implantation).
- To compare the appearance and persistence of late complications (from 30 days onwards).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands
- •Age > or = 40 years
- •informed consent signed by the patient
排除标准
- •patients who are pregnant or wish to become
- •patients who need anticoagulant
- •active vaginal or urinary infection
- •previous surgical interventions for the treatment of incontinence
- •body mass index > 35
结局指标
主要结局
Continence rate (Objective) assessed by an effort test
时间窗: Year 5
For the analysis of the objective cure of incontinence, an effort test will be carried out through three strokes of cough, with bladder volume between 200-300 ml in a lithotomy position.
次要结局
- Pad test(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Evaluation of sexual life, assessed by PSIQ 12 questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire )(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Early complications assessed by Post-Mictional Residue(Day 0, 7-10 days after the intervention, Month 1)
- Patient satisfaction assessed by PGI-I (Patient Global Impression of Improvement)(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Patient satisfaction assessed by the "Global Satisfaction Test"(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Patient satisfaction assessed by the "Recommendations questionnarie"(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Continence rate (Subjective) assessed by Incontinence Questionnaire-Urinary Short Form (ICQ-SF)(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Early complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire)(Day 0, 7-10 days after the intervention, Month 1)
- Long term complications assessed by "Extrusion" (integrity of the vaginal mucus)(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Long term complications assessed by "Emptying dysfunction"(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Evaluation of life quality improvement assessed by I-QoL questionnaire (Urinary Incontinence-Specific Quality of Life Instrument)(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Long term complications assessed by emergence of recurrent urinary tract infections (UTIs)(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Long term complications assessed by OAB-q questionnaire (Overactive Bladder symptom and health-related quality of life questionnaire)(Month 1, month 6, year 1, year 2, year 3, year 4 and year 5.)
- Early complications assessed by VAS (Visual Analogue Scale)(Day 0, 7-10 days after the intervention, Month 1)
研究者
研究点 (1)
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