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

Stress Urinary Incontinence Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04558762
• Other study ID #: MUS and SUI
• Status: Not yet recruiting
• Start date: September 2020
• Est. completion date: October 2022

Study information

• Verified date: September 2020
• Source: Stockholm South General Hospital
• Contact: Marion Ek
• Phone: +4686161000
• Email: marion.ek[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: October 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and Gynecology, Stockholm South General Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Stockholm South General Hospital	Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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