Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence

Study Overview
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Brief Summary
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The investigators intend to investigate the long-term complications and the subjective well-being among women who underwent insertion of a MUS due to stress urinary incontinence 2006-2010.

Official Title
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Ten Years Follow-up, Efficacy and Complications, After Insertion of a MUS Due to Stress Urinary Incontinence, According to the Swedish National Quality Register of Gynecological Surgery.

Conditions
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Stress Urinary Incontinence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence. Were registered in The Swedish National Quality Register of Gynecological Surgery. Exclusion Criteria: Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Women who had a MUS inserted.<br>Women who underwent surgery with insertion of a MUS due to SUI 2006-2010 in Sweden with the MUS coming out retropubic (TVT) or through foramen obturatorium (TOT). | |
| Controls<br>Women who have not had a MUS inserted due to stress urinary incontinence. Matched in age. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress urinary incontinence | We will measure the percentage of women who suffer from a subjective feeling of stress urinary incontinence ten years after surgery. We will use validated scales; UDI-6 ( Urogenital Distress Inventory), IIQ-7 (Incontinence Impact Questionnaire). | +10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with late post operative complications | Late complications due to surgery such as erosion of the mesh. We will send questionnaires to all participants concerning late post operative complications and we will ask specific questions about additional surgery that has been done after the first surgery. | +10 years after surgery | 
| Number of patients with pelvic pain | Late complications due to surgery such as pelvic pain. We will send out questionnaires specifically asking about pelvic pain. | +10 years after surgery | 
| Number of participants with groin pain | Late complications due to surgery such as groin pain. We will send out questionnaires specifically asking about groin pain. | +10 years after surgery | 
| Number of participants with dyspareunia | Pain during sexual intercourse will be measured by the validated scale PISQ-12 (Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire). | +10 years after surgery | 
| Number of participants that has had a reoperation | Reoperation due to complication after the first surgery. We will ask this in a questionnaire sent to all participants. | Up to 14 years after first surgery |