Urinary Incontinence,Stress
Conditions
Keywords
Surgery, Suburethral Slings, Tension-free vaginal tape
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.
Interventions
PROCEDURETension-free vaginal tape
female incontinence surgery with polypropylene tape applied
Sponsors
St. Olavs Hospital
Alesund Hospital
Oslo University Hospital
Norwegian University of Science and Technology
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of persistant pelvic pain after TVT surgery | 20 years | — |
| prevalence or persistant pelvic pain after TVT surgery | 10 years | — |
| subjective cure rate | 20 years | assessed by stress index; stress index \<=3 is considered 'successful' |
| Urinary bladder microbiota | 20 years | assessed by quadruplex PCR |
| Tension free vaginal tape placement along the urethra assessed with ultrasound | 20 years | — |
| Sexually active | 20 years | yes/no question |
| Levator avulsion assessed by ultrasound | 20 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of surgical TVT removal | 20 years | — |
| Prevalence of recurrent surgery for stress urinary incontinence | 20 years | — |
| prevalence of recurrent surgery for stress urinary incontinence | 10 years | — |
| Quality of life assessed by RAND-36 questionnaire | 20 years | The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation) |
| Pelvic organ prolapse assessed by POP-Q at clinical examination | 20 years | Pelvic organ prolapse quantification system (POP-Q) |
| Symptoms of pelvic floor disorders assessed by PFDI questionnaire | 20 years | Pelvic floor distress inventory (PFDI) |
Countries
Norway
Outcome results
None listed