Status:
COMPLETED
Credibility of Ultrasound Detection of Female Genital Prolapse Mesh
Lead Sponsor:
Karolinska Institutet
Conditions:
Ultrasound Therapy; Complications
Eligibility:
FEMALE
18-99 years
Brief Summary
The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound examiner experience a...
Detailed Description
Pelvic organ prolapse (POP) is a common condition in post-delivery and post-reproductive aged women (1). The lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 is 11...
Eligibility Criteria
Inclusion
- Patients operated by one of the procedures mentioned 1. Anterior TVM (Uphold™ Lite Vaginal mesh - Boston Scientific. 2. Posterior POP mesh (Pinnacle posterior - Boston Scientific or equal) 3. Y-shaped mesh via robotic assisted sacroclpopexy (Artisyn® Y-Shaped Mesh - Ethicon or equal). and 4. patients received anterior and/or posterior colporraphy i.e. native tissue repair i.e. no synthetic materials used (control group).
- All patients should have suffered prolapse symptoms before surgery such as pelvic heaviness and/or vaginal bulging, extra.
- Being able to make an informed consent on participation
- Physically and cognitively capable of participating in the examination
- No exclusion criteria fulfilled
Exclusion
- Patients operated by different procedures t.ex. two different mesh types
- Advanced procedure in the pelvic floor such as current pelvic organ cancer (regardless of treatment)
- Other clinically relevant pelvic disorders for which surgery with other materials (not polypropylene mesh) was previously provided.
Key Trial Info
Start Date :
October 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06000215
Start Date
October 21 2018
End Date
December 21 2018
Last Update
August 22 2023
Active Locations (1)
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1
Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital
Stockholm, Sweden, 18288