Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years
- Conditions
- Urinary Incontinence,Stress
- Interventions
- Procedure: Tension-free vaginal tape
- Registration Number
- NCT04912830
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1210
- 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)
- Dead
- Not willing to participate
- Moved out of Norway
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 10 years follow-up after TVT surgery, age 42 or younger Tension-free vaginal tape 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 20 years follow-up after TVT surgery Tension-free vaginal tape Women who had tension free vaginal tape surgery during January 2001-December 2002 in Norway, identified in the National Incontinence Registry
- Primary Outcome Measures
Name Time Method prevalence of persistant pelvic pain after TVT surgery 20 years Tension free vaginal tape placement along the urethra assessed with ultrasound 10 years subjective cure rate 10 years assessed by stress index; stress index \<=3 is considered 'successful'
Sexually active 10 years yes/no question
Levator avulsion assessed by ultrasound 10 years prevalence or persistant pelvic pain after TVT surgery 10 years Urinary bladder microbiota 10 years assessed by quadruplex PCR
- Secondary Outcome Measures
Name Time Method prevalence of surgical TVT removal 10 years prevalence of recurrent surgery for stress urinary incontinence 10 years Symptoms of pelvic floor disorders assessed by PFDI questionnaire 10 years Pelvic floor distress inventory (PFDI)
Prevalence of recurrent surgery for stress urinary incontinence 20 years Quality of life assessed by RAND-36 questionnaire 10 years The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Pelvic organ prolapse assessed by POP-Q at clinical examination 10 years Pelvic organ prolapse quantification system (POP-Q)
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway