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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Absorbable Sutures in Perineal Laceration Repair

NCT00223119

Perineal Laceration Repair

TERMINATED PHASE4

Study of Different Suturing Techniques for Perineal Repair After Delivery

NCT00265421

Perineal Lacerations Episiotomy

COMPLETED NA

Comparison of Sacrospinous Ligament Fixation and Uterosacral Ligament Suspension for Apical Prolapse Surgery: A Randomized Clinical Trial

NCT05668130

Pelvic Organ Prolapse

UNKNOWN NA

Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

NCT03736811

Pelvic Organ Prolapse

UNKNOWN NA

Permanent Versus Absorbable Colpopexy Trial

NCT02277925

Pelvic Organ Prolapse

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence,Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

20 years follow-up after TVT surgery

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

Tension-free vaginal tape

Intervention Type PROCEDURE

female incontinence surgery with polypropylene tape applied

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

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

Tension-free vaginal tape

Intervention Type PROCEDURE

female incontinence surgery with polypropylene tape applied

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.