Stress Urinary IncontinenceNCT04558762
Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
An observational study of Stress Urinary Incontinence, run by Stockholm South General Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 15,000 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2020to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence.
- Were registered in The Swedish National Quality Register of Gynecological Surgery.
Who cannot join
- Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Obstetrics and Gynecology, Stockholm South General Hospital
Stockholm, 11883
Anna Drca, MD, +46705618733, anna.lundmark-drca@sll.se
Vasileios Alexandridis, MD, +46760850922, vasileios.alexandridis@skane.se
About this study
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.
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.
- Conditions
- Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: +10 years after surgery
Secondary outcomes (5)
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.
Measured: +10 years after surgery
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.
Measured: +10 years after surgery
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.
Measured: +10 years after surgery
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).
Measured: +10 years after surgery
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.
Measured: Up to 14 years after first surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Principal investigator, Marion Ek, Stockholm South General Hospital
- Investigators
- Marion Ek, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558762
- Sponsor's protocol ID
- MUS and SUI
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04558762
- Acronym / sponsor ID
- MUS and SUI
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence.
- Were registered in The Swedish National Quality Register of Gynecological Surgery.
Key exclusion criteria (1 listed)
- Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
Number of participants with late post operative complications
Time frame: +10 years after surgery
Number of patients with pelvic pain
Time frame: +10 years after surgery
Number of participants with groin pain
Time frame: +10 years after surgery
Number of participants with dyspareunia
Time frame: +10 years after surgery
Number of participants that has had a reoperation
Time frame: Up to 14 years after first surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Ek, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Stockholm South General Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion Ek (+4686161000, marion.ek@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress urinary incontinence (time frame: +10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.