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

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

Study Contact Backup

Study Locations

      • Stockholm, Sweden, 11883
        • Department of Obstetrics and Gynecology, Stockholm South General Hospital
        • Contact:
        • Principal Investigator:
          • Marion Ek, PhD, MD
        • Contact:
        • Principal Investigator:
          • Pia Teleman, PhD, MD

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
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 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).
+10 years after surgery

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.
+10 years after surgery
Number of patients with pelvic pain
Time Frame: +10 years after surgery
Late complications due to surgery such as pelvic pain. We will send out questionnaires specifically asking about pelvic pain.
+10 years after surgery
Number of participants with groin pain
Time Frame: +10 years after surgery
Late complications due to surgery such as groin pain. We will send out questionnaires specifically asking about groin pain.
+10 years after surgery
Number of participants with dyspareunia
Time Frame: +10 years after surgery
Pain during sexual intercourse will be measured by the validated scale PISQ-12 (Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire).
+10 years after surgery
Number of participants that has had a reoperation
Time Frame: Up to 14 years after first surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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.

Clinical Trials on Stress Urinary Incontinence

3
Subscribe