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The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.
Full description
Patients with pelvic organ prolapse are administrated partially absorbable mesh(Seratom®PA). It is performed pelvic organ prolapse quantification(POP-Q) examination, quality of life(QOL) questionnaire complications at postop 2week, 12week, 24week.
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Inclusion criteria
Exclusion criteria
Subjects who have medical contractions, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use, or a compromised immune system
Subjects who have received anticoagulation therapy
Subjects who are on current intermittent catheterization
Subjects whose BMI is over 30kg/m2
Subjects who have uncontrolled diabetes
Subjects who are on any medication which could result in compromised immune response, such as immune modulators
Subjects who are currently pregnant or intends to become pregnant during the study period or <12 months post-partum
Subjects who have received other laparoscopic or abdominal or pelvic surgery in the past 1 months
Subjects who need for concomitant surgery requiring an abdominal incision
Subjects who have had a prior prolapse implant procedure (i.e. IVS tunneler, Perigee, Apogee, graft augmented repair, etc)
Subjects who have had radiation therapy to the pelvic area
Subjects who have pelvic cancer or have had pelvic cancer within the past 12 months or have had on cytostatic medication within the past 12 months
Subjects who have a shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys.)
Subjects who have a known neurologic or medical condition affecting bladder function (e.g. Multiple Sclerosis, spinal cord injury)
Subjects who have a known hypersensitivity to the graft material(s)
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Allocation
Interventional model
Masking
50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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