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临床试验/NCT04912830
NCT04912830已完成不适用

Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 1,210 人开始时间: 2021年10月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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