Safety and Efficacy of Low-elasticity Polyvinylidene Fluoride (DynaMesh®-SIS Soft) Retropubic Tension Free Midurethral Sling in the Treatment of Stress Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Julie Dawson
- 入组人数
- 218
- 试验地点
- 10
- 主要终点
- The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of stress urinary incontinence in women. Women who are having a retropubic PVDF midurethral sling for urodynamic stress incontinence will be followed up for 24 months to address its efficacy and rate of complications.
详细描述
This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of stress urinary incontinence (SUI) in women.
Stress urinary incontinence is a common problem, affecting large numbers of women. If conservative measures are ineffective then surgery is offered. Surgery involves a permanent mesh sling being placed, tension free beneath the midurethra. The standard retropubic tension-free vaginal tape (TVT) has been used since 1996 using a polypropylene mesh.(1) The use of permanent mesh in gynaecology has come under scrutiny due to significant complications for women.(2) This year the Medicines and Healthcare Products Regulatory Agency (MHRA), UK concluded that there is not enough evidence to withdraw mesh from clinical usage.(3)
The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.(4) Each sling is individually woven and and has low elasticity meaning dimensions are maintained under tension, such as with coughing or straining. The technique of retropubic placement of the DynaMesh®SIS soft does not differ from current retropubic TVT placement.
The hypothesis is that the low elasticity polyvinylidene fluoride midurethral sling is non-inferior in both safety and efficacy compared with the safety and efficacy of traditional polypropylene slings, as reported in current literature.
There are eleven research centres in two countries, The United Kingdom and Ireland. The DynaMesh®SIS soft sling is currently in use in four of eleven of the research hospitals, Norwich (main research centre), Antrim and Belfast in the UK and in Munich in Germany. It will be introduced in London, Cambridge, Wirral, Solihull, Huntingdon and Kilmarnock in the UK and Wurzbug in Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with proven urodynamic stress incontinence in whom a retropubic midurethral sling is appropriate treatment as per the treating urogynaecologist, gynaecologist or urologist
- •women who have not had a previous incontinence procedure
- •no concomitant prolapse procedure at the time of sling placement
排除标准
- •urodynamic studies negative for stress urinary incontinence
- •previous incontinence procedures
- •non English/non German speaker depending on study centre
- •lack capacity to consent
结局指标
主要结局
The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.
时间窗: 3 to 24 months
The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.
时间窗: 3 to 24 months
次要结局
- The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence compared to the reported cure rate for traditional polypropylene retropubic slings.(3 to 24 months)
- The rate of complications of retropubic midurethral PVDF slings, in particular vaginal erosions and how the rates of complications compare to those reported in the literature for traditional polypropylene retropubic slings.(3-24 months)
- Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.(3 to 24 months)
研究者
Julie Dawson
Research Services Manager
Norfolk and Norwich University Hospitals NHS Foundation Trust