St Olavs Hospital
Trondheim, Norway
NCT Number: NCT04912830
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.
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Notify Me40 year–95 year
Female
Observational
Trondheim, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
female incontinence surgery with polypropylene tape applied
Time frame: 20 years
Time frame: 10 years
Time frame: 20 years
assessed by stress index; stress index <=3 is considered 'successful'
Time frame: 10 years
assessed by stress index; stress index <=3 is considered 'successful'
Time frame: 20 years
assessed by quadruplex PCR
Time frame: 10 years
assessed by quadruplex PCR
Time frame: 20 years
Time frame: 10 years
Time frame: 20 years
yes/no question
Time frame: 10 years
yes/no question
Time frame: 20 years
Time frame: 10 years
Time frame: 20 years
Time frame: 10 years
Time frame: 20 years
Time frame: 10 years
Time frame: 20 years
The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Time frame: 10 years
The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation)
Time frame: 20 years
Pelvic organ prolapse quantification system (POP-Q)
Time frame: 10 years
Pelvic organ prolapse quantification system (POP-Q)
Time frame: 20 years
Pelvic floor distress inventory (PFDI)
Time frame: 10 years
Pelvic floor distress inventory (PFDI)
Norwegian University of Science and Technology
Other
Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications
Acronym: TVTOPP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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