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

NCT ID: NCT04558762

Last Updated: 2020-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

No interventions assigned to this group

Controls

Women who have not had a MUS inserted due to stress urinary incontinence. Matched in age.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Skane University Hospital

OTHER

Sponsor Role collaborator

Stockholm South General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marion Ek

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marion Ek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Obstetrics and Gynecology, Stockholm South General Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marion Ek

Role: CONTACT

+4686161000

Anna Drca

Role: CONTACT

+4686162646

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna Drca, MD

Role: primary

+46705618733

Vasileios Alexandridis, MD

Role: backup

+46760850922

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MUS and SUI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mid-Urethral Sling Tensioning Trial
NCT02480231 COMPLETED NA