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.
Study Type
OBSERVATIONAL
Enrollment
1,210
female incontinence surgery with polypropylene tape applied
St Olavs Hospital
Trondheim, Norway
prevalence of persistant pelvic pain after TVT surgery
Time frame: 20 years
prevalence or persistant pelvic pain after TVT surgery
Time frame: 10 years
subjective cure rate
assessed by stress index; stress index \<=3 is considered 'successful'
Time frame: 20 years
subjective cure rate
assessed by stress index; stress index \<=3 is considered 'successful'
Time frame: 10 years
Urinary bladder microbiota
assessed by quadruplex PCR
Time frame: 20 years
Urinary bladder microbiota
assessed by quadruplex PCR
Time frame: 10 years
Tension free vaginal tape placement along the urethra assessed with ultrasound
Time frame: 20 years
Tension free vaginal tape placement along the urethra assessed with ultrasound
Time frame: 10 years
Sexually active
yes/no question
Time frame: 20 years
Sexually active
yes/no question
Time frame: 10 years
Levator avulsion assessed by ultrasound
Time frame: 20 years
Levator avulsion assessed by ultrasound
Time frame: 10 years
prevalence of surgical TVT removal
Time frame: 20 years
prevalence of surgical TVT removal
Time frame: 10 years
Prevalence of recurrent surgery for stress urinary incontinence
Time frame: 20 years
prevalence of recurrent surgery for stress urinary incontinence
Time frame: 10 years
Quality of life assessed by RAND-36 questionnaire
The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Time frame: 20 years
Quality of life assessed by RAND-36 questionnaire
The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Time frame: 10 years
Pelvic organ prolapse assessed by POP-Q at clinical examination
Pelvic organ prolapse quantification system (POP-Q)
Time frame: 20 years
Pelvic organ prolapse assessed by POP-Q at clinical examination
Pelvic organ prolapse quantification system (POP-Q)
Time frame: 10 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire
Pelvic floor distress inventory (PFDI)
Time frame: 20 years
Symptoms of pelvic floor disorders assessed by PFDI questionnaire
Pelvic floor distress inventory (PFDI)
Time frame: 10 years
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