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

Norwegian University of Science and Technology

Status: Completed

Conditions: Urinary Incontinence,Stress

Treatments: Procedure: Tension-free vaginal tape

Study type: Observational

Funder types: Other

Identifiers

NCT04912830

141799

Details and patient eligibility

About

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.

Enrollment: 1,210 patients

Sex: Female

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Dead
• Not willing to participate
• Moved out of Norway

Trial design

1,210 participants in 2 patient groups

20 years follow-up after TVT surgery

Description:

Women who had tension free vaginal tape surgery during January 2001-December 2002 in Norway, identified in the National Incontinence Registry

Treatment:

Procedure: Tension-free vaginal tape

10 years follow-up after TVT surgery, age 42 or younger

Description:

Women who had tension free vaginal tape surgery and aged \< 42 years at the time of surgery during 2011-2012 in Norway, identified in the National Incontinence Registry

Treatment:

Procedure: Tension-free vaginal tape