Skip to content

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04558762
Enrollment
15000
Registered
2020-09-22
Start date
2020-09-30
Completion date
2022-10-31
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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.

Interventions

None listed

Sponsors

Skane University Hospital
CollaboratorOTHER
Stockholm South General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stress urinary incontinence+10 years after surgeryWe 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

MeasureTime frameDescription
Number of participants with late post operative complications+10 years after surgeryLate 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 surgeryLate 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 surgeryLate complications due to surgery such as groin pain. We will send out questionnaires specifically asking about groin pain.
Number of participants with dyspareunia+10 years after surgeryPain 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 reoperationUp to 14 years after first surgeryReoperation due to complication after the first surgery. We will ask this in a questionnaire sent to all participants.

Countries

Sweden

Contacts

Primary ContactMarion Ek
marion.ek@sll.se+4686161000
Backup ContactAnna Drca
anna.lundmark-drca@sll.se+4686162646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026