Pelvic Organ Prolapse
Conditions
Keywords
Partially absorbable mesh
Brief summary
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.
Detailed 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.
Interventions
DEVICESeratom® PA mesh
Partially absorbable mesh
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Woman who aged 41 years or older 2. Subjects who have symptomatic pelvic organ prolapse quantification(POP-Q) stage II & cystocele or higher requiring surgical repair 3. Subjects who desires vaginal reconstructive surgery 4. Subjects who have uterus \< 12 weeks size 5. Subjects who are able to complete study questionnaires and assessment 6. Subjects who are available for 6 months follow-up
Exclusion criteria
1. 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 2. Subjects who have received anticoagulation therapy 3. Subjects who are on current intermittent catheterization 4. Subjects whose BMI is over 30kg/m2 5. Subjects who have uncontrolled diabetes 6. Subjects who are on any medication which could result in compromised immune response, such as immune modulators 7. Subjects who are currently pregnant or intends to become pregnant during the study period or \<12 months post-partum 8. Subjects who have received other laparoscopic or abdominal or pelvic surgery in the past 1 months 9. Subjects who need for concomitant surgery requiring an abdominal incision 10. Subjects who have had a prior prolapse implant procedure (i.e. IVS tunneler, Perigee, Apogee, graft augmented repair, etc) * Note: previous traditional repairs are allowed. 11. Subjects who have had radiation therapy to the pelvic area 12. 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 13. Subjects who have a shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys.) 14. Subjects who have a known neurologic or medical condition affecting bladder function (e.g. Multiple Sclerosis, spinal cord injury) 15. Subjects who have a known hypersensitivity to the graft material(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pelvic Organ Prolapse Quantification(POP-Q) stage | Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week |
| Surgical revision rate | For post op 6 months from baseline |
Secondary
| Measure | Time frame |
|---|---|
| No of patients complications occurred | For post op 6 months from baseline |
Countries
South Korea
Outcome results
None listed