CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,210 enrolled
Drug / intervention
Tension-free vaginal tapeprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04912830
NCT04912830N/ACompleted

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

Norwegian University of Science and Technology·observational·Posted Jun 3, 2021·Updated Jan 3, 2024

In Brief

An observational study evaluating Tension-free vaginal tape for Urinary Incontinence,Stress. Completed, enrolled 1,210 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNorway

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 3, 2021
Enrollment StartOct 1, 2021
Primary CompletionFeb 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.1 years ago

Interventions

Tension-free vaginal tapeprocedure

female incontinence surgery with polypropylene tape applied