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

Samyang Biopharmaceuticals Corporation1 site in 1 country50 target enrollmentDecember 2014

ConditionsPelvic Organ Prolapse

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Samyang Biopharmaceuticals Corporation
Enrollment: 50
Locations: 1
Primary Endpoint: Pelvic Organ Prolapse Quantification(POP-Q) stage
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

April 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Samyang Biopharmaceuticals Corporation

Responsible Party

Sponsor

Eligibility Criteria

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)