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

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04558762
• Lead Sponsor: Stockholm South General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22
• Primary Completion: 2021-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress urinary incontinence	+10 years after surgery	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Stockholm South General Hospital; 🇸🇪 Stockholm, Sweden