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

NCT04912830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1210

Last updated 2024-01-03

No results posted yet for this study

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

PROCEDURE

Tension-free vaginal tape

female incontinence surgery with polypropylene tape applied

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Alesund Hospital

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Torstein Baade Rø, phd prof · NTNU, Department of Clinical and Molecular Medicine

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-02-15
Completion
2023-02-15

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912830 on ClinicalTrials.gov