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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04558762
Other study ID # MUS and SUI
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2020
Est. completion date October 2022

Study information

Verified date September 2020
Source Stockholm South General Hospital
Contact Marion Ek
Phone +4686161000
Email marion.ek@sll.se
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15000
Est. completion date October 2022
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Sweden Department of Obstetrics and Gynecology, Stockholm South General Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Stockholm South General Hospital Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). +10 years after surgery
Secondary 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. +10 years after surgery
Secondary 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. +10 years after surgery
Secondary 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. +10 years after surgery
Secondary 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). +10 years after surgery
Secondary 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. Up to 14 years after first surgery
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