A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh in Patients With Pelvic Organ Prolapsed

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh(Seratom PA®) in Patients With Pelvic Organ Prolapsed

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Seratom® PA mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman who aged 41 years or older Subjects who have symptomatic pelvic organ prolapse quantification(POP-Q) stage II & cystocele or higher requiring surgical repair Subjects who desires vaginal reconstructive surgery Subjects who have uterus < 12 weeks size Subjects who are able to complete study questionnaires and assessment Subjects who are available for 6 months follow-up 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) Note: previous traditional repairs are allowed. 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)

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seratom® PA mesh<br>Partially absorbable mesh | Device: Seratom® PA mesh<br>* Partially absorbable mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No of patients complications occurred |  | For post op 6 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partially absorbable mesh