Clinical trial NCT04912830: Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years
Official title: Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence,Stress
Keywords: Surgery
Suburethral Slings
Tension-free vaginal tape
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Alesund Hospital
name: Oslo University Hospital
First posted: 2021-06-03
Enrollment: 1210
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who had tension free vaginal tape surgery 10 and 20 years ago in Norway, identified in the National Incontinence Registry (Norsk Kvinnelig Inkontinens Register (NKIR).

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.


Eligibility criteria: 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

Primary outcomes:
measure: prevalence of persistant pelvic pain after TVT surgery
timeFrame: 20 years
measure: prevalence or persistant pelvic pain after TVT surgery
timeFrame: 10 years
measure: subjective cure rate
timeFrame: 20 years
measure: subjective cure rate
timeFrame: 10 years
measure: Urinary bladder microbiota
timeFrame: 20 years
measure: Urinary bladder microbiota
timeFrame: 10 years
measure: Tension free vaginal tape placement along the urethra assessed with ultrasound
timeFrame: 20 years
measure: Tension free vaginal tape placement along the urethra assessed with ultrasound
timeFrame: 10 years
measure: Sexually active
timeFrame: 20 years
measure: Sexually active
timeFrame: 10 years
measure: Levator avulsion assessed by ultrasound
timeFrame: 20 years
measure: Levator avulsion assessed by ultrasound
timeFrame: 10 years
Secondary outcomes:
measure: prevalence of surgical TVT removal
timeFrame: 20 years
measure: prevalence of surgical TVT removal
timeFrame: 10 years
measure: Prevalence of recurrent surgery for stress urinary incontinence
timeFrame: 20 years
measure: prevalence of recurrent surgery for stress urinary incontinence
timeFrame: 10 years
measure: Quality of life assessed by RAND-36 questionnaire
timeFrame: 20 years
measure: Quality of life assessed by RAND-36 questionnaire
timeFrame: 10 years
measure: Pelvic organ prolapse assessed by POP-Q at clinical examination
timeFrame: 20 years
measure: Pelvic organ prolapse assessed by POP-Q at clinical examination
timeFrame: 10 years
measure: Symptoms of pelvic floor disorders assessed by PFDI questionnaire
timeFrame: 20 years
measure: Symptoms of pelvic floor disorders assessed by PFDI questionnaire
timeFrame: 10 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: NTNU, Department of Clinical and Molecular Medicine
name: Torstein Baade Rø, phd prof
role: STUDY_DIRECTOR
References: