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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Seratom® PA mesh

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samyang Biopharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seratom® PA mesh; Partially absorbable mesh	Device: Seratom® PA mesh; Partially absorbable mesh

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Investigators: Principal Investigator: Kwon Sang Hoon, Doctor, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Partially absorbable mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: POP-SERATOM PA