Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
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.
1 other identifier
observational
15,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 4, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedSeptember 22, 2020
September 1, 2020
1.1 years
September 4, 2020
September 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of participants with late post operative complications
+10 years after surgery
Number of patients with pelvic pain
+10 years after surgery
Number of participants with groin pain
+10 years after surgery
Number of participants with dyspareunia
+10 years after surgery
Number of participants that has had a reoperation
Up to 14 years after first surgery
Study Arms (2)
Women who had a MUS inserted.
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
Women who have not had a MUS inserted due to stress urinary incontinence. Matched in age.
Eligibility Criteria
Women who underwent MUS surgery in Sweden 2006-2010 due to stress urinary incontinence. The controlgroup will consist of women who did not undergo this surgery but are matched in age with the women who underwent surgery.
You may qualify if:
- Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence.
- Were registered in The Swedish National Quality Register of Gynecological Surgery.
You may not qualify if:
- Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stockholm South General Hospitallead
- Skane University Hospitalcollaborator
Study Sites (1)
Department of Obstetrics and Gynecology, Stockholm South General Hospital
Stockholm, 11883, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marion Ek, MD, PhD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant
Study Record Dates
First Submitted
September 4, 2020
First Posted
September 22, 2020
Study Start
September 1, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
September 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share