Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years

Study Overview
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Brief Summary
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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.

Official Title
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Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years: Success Rate and Long-term Complications

Conditions
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Urinary Incontinence,Stress

Intervention / Treatment
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* Procedure: Tension-free vaginal tape


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 years follow-up after TVT surgery<br>Women who had tension free vaginal tape surgery during January 2001-December 2002 in Norway, identified in the National Incontinence Registry | Procedure: Tension-free vaginal tape<br>* female incontinence surgery with polypropylene tape applied<br>|
| 10 years follow-up after TVT surgery, age 42 or younger<br>Women who had tension free vaginal tape surgery and aged < 42 years at the time of surgery during 2011-2012 in Norway, identified in the National Incontinence Registry | Procedure: Tension-free vaginal tape<br>* female incontinence surgery with polypropylene tape applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of persistant pelvic pain after TVT surgery |  | 20 years | 
| prevalence or persistant pelvic pain after TVT surgery |  | 10 years | 
| subjective cure rate | assessed by stress index; stress index <=3 is considered 'successful' | 20 years | 
| subjective cure rate | assessed by stress index; stress index <=3 is considered 'successful' | 10 years | 
| Urinary bladder microbiota | assessed by quadruplex PCR | 20 years | 
| Urinary bladder microbiota | assessed by quadruplex PCR | 10 years | 
| Tension free vaginal tape placement along the urethra assessed with ultrasound |  | 20 years | 
| Tension free vaginal tape placement along the urethra assessed with ultrasound |  | 10 years | 
| Sexually active | yes/no question | 20 years | 
| Sexually active | yes/no question | 10 years | 
| Levator avulsion assessed by ultrasound |  | 20 years | 
| Levator avulsion assessed by ultrasound |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of surgical TVT removal |  | 20 years | 
| prevalence of surgical TVT removal |  | 10 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 | The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation) | 20 years | 
| Quality of life assessed by RAND-36 questionnaire | The RAND 36-Item Health Survey 1.0 (distributed by RAND, Norwegian translation) | 10 years | 
| Pelvic organ prolapse assessed by POP-Q at clinical examination | Pelvic organ prolapse quantification system (POP-Q) | 20 years | 
| Pelvic organ prolapse assessed by POP-Q at clinical examination | Pelvic organ prolapse quantification system (POP-Q) | 10 years | 
| Symptoms of pelvic floor disorders assessed by PFDI questionnaire | Pelvic floor distress inventory (PFDI) | 20 years | 
| Symptoms of pelvic floor disorders assessed by PFDI questionnaire | Pelvic floor distress inventory (PFDI) | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Suburethral Slings, Tension-free vaginal tape