- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558762
Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
September 15, 2020 updated by: Marion Ek, Stockholm South General Hospital
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.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
15000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marion Ek
- Phone Number: +4686161000
- Email: marion.ek@sll.se
Study Contact Backup
- Name: Anna Drca
- Phone Number: +4686162646
- Email: anna.lundmark-drca@sll.se
Study Locations
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-
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Stockholm, Sweden, 11883
- Department of Obstetrics and Gynecology, Stockholm South General Hospital
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Contact:
- Anna Drca, MD
- Phone Number: +46705618733
- Email: anna.lundmark-drca@sll.se
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Principal Investigator:
- Marion Ek, PhD, MD
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Contact:
- Vasileios Alexandridis, MD
- Phone Number: +46760850922
- Email: vasileios.alexandridis@skane.se
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Principal Investigator:
- Pia Teleman, PhD, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress urinary incontinence
Time Frame: +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).
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+10 years after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with late post operative complications
Time Frame: +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.
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+10 years after surgery
|
Number of patients with pelvic pain
Time Frame: +10 years after surgery
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Late complications due to surgery such as pelvic pain.
We will send out questionnaires specifically asking about pelvic pain.
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+10 years after surgery
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Number of participants with groin pain
Time Frame: +10 years after surgery
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Late complications due to surgery such as groin pain.
We will send out questionnaires specifically asking about groin pain.
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+10 years after surgery
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Number of participants with dyspareunia
Time Frame: +10 years after surgery
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Pain during sexual intercourse will be measured by the validated scale PISQ-12 (Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire).
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+10 years after surgery
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Number of participants that has had a reoperation
Time Frame: Up to 14 years after first surgery
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Reoperation due to complication after the first surgery.
We will ask this in a questionnaire sent to all participants.
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Up to 14 years after first surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marion Ek, MD, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
September 4, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 22, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUS and SUI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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