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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04912830
Other study ID # 141799
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date February 15, 2023

Study information

Verified date January 2024
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1210
Est. completion date February 15, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 95 Years
Eligibility 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

Study Design


Intervention

Procedure:
Tension-free vaginal tape
female incontinence surgery with polypropylene tape applied

Locations

Country Name City State
Norway St Olavs Hospital Trondheim

Sponsors (4)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Alesund Hospital, Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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