Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,210
- 试验地点
- 1
- 主要终点
- prevalence of persistant pelvic pain after TVT surgery
研究概览
简要总结
Over the past 5-7 years there has been increasing concern about the use of polypropylene tapes in female incontinence surgery. There has been a special focus on pain in the vagina and lower abdomen and pain during sexual intercourse. Some have also asked if the polypropylene tape could cause impairment of the immune system leading to allergy, connective tissue disorders etc. There are still only a few publications on complications after sling surgery.
In Norway it is mandatory to register all incontinence surgery in the National incontinence registry (Norsk Kvinnelig Inkontinens Register (NKIR). In 2019 >99 % of all procedures were registered in this registry. Data about type and severity of incontinence are registered, as well as complications at surgery. The same data are entered at a 6 months and 3 years follow up. Data for the follow up visits are not complete. The NKIR registry and other similar registries have been criticized for not following the women long enough and therefore missing important information regarding long-term complications. Few studies have followed the women for a longer time after surgery. The main aim of this study is to find the prevalence of women still satisfied with the TVT surgery and the prevalence of long-term complications after 10 and 20 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 95 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •had TVT surgery in Norway January 2001-December 2002 (20-years follow-up cohort)
- •had TVT surgery in Norway, < 42 years at the time of surgery in 2011-2012 (10-years follow-up cohort)
排除标准
- •Not willing to participate
- •Moved out of Norway
结局指标
主要结局
prevalence of persistant pelvic pain after TVT surgery
时间窗: 20 years
Tension free vaginal tape placement along the urethra assessed with ultrasound
时间窗: 10 years
subjective cure rate
时间窗: 10 years
assessed by stress index; stress index \<=3 is considered 'successful'
Sexually active
时间窗: 10 years
yes/no question
Levator avulsion assessed by ultrasound
时间窗: 10 years
prevalence or persistant pelvic pain after TVT surgery
时间窗: 10 years
Urinary bladder microbiota
时间窗: 10 years
assessed by quadruplex PCR
次要结局
- prevalence of surgical TVT removal(10 years)
- prevalence of recurrent surgery for stress urinary incontinence(10 years)
- Symptoms of pelvic floor disorders assessed by PFDI questionnaire(10 years)
- Prevalence of recurrent surgery for stress urinary incontinence(20 years)
- Quality of life assessed by RAND-36 questionnaire(10 years)
- Pelvic organ prolapse assessed by POP-Q at clinical examination(10 years)
