NCT04912830

Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,210 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Female
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urinary Incontinence,Stress

Interventions

Type	Name	Description
PROCEDURE	Tension-free vaginal tape	female incontinence surgery with polypropylene tape applied

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2021-06-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: Norway