Status:
COMPLETED
Safety Study of Pelvic Organ Prolapse Repair Using Transvaginal Mesh
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska University Hospital
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For decades, suture repair techniques have been the primary choice of ...
Detailed Description
Main objective: \- To describe short and long-term complications associated with pelvic organ prolapse repair using macroporous polypropylene transvaginal mesh (TVM) using a transobturator or transgl...
Eligibility Criteria
Inclusion
- Pelvic organ prolapse stage 2 or more according to the POP-Q staging system
- Symptoms related to pelvic organ prolapse including bulging, pelvic heaviness and vaginal protrusion
- Able to make an informed consent to participate
- Physically and mentally able to participate in follow-up
Exclusion
- Previous pelvic organ cancer regardless of treatment
- Severe rheumatic disease requiring per oral steroid treatment
- Systemic connective tissue disorder (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
- Physically or mentally unable to participate in follow-up or give informed consent to participate in the study
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00402844
Start Date
August 1 2006
End Date
March 1 2007
Last Update
November 14 2007
Active Locations (26)
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1
Nyköbing Hospital
Nyköbing, Denmark
2
Skejby Hospital
Skejby, Denmark
3
Jorvi Hospital
Jorvi, Finland
4
Lahti Hospital
Lahti, Finland