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

NCT ID: NCT02320643

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-04-30

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seratom® PA mesh

Partially absorbable mesh

Group Type: EXPERIMENTAL

Seratom® PA mesh

Intervention Type: DEVICE

Partially absorbable mesh

Interventions

Seratom® PA mesh

Partially absorbable mesh

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kwon Sang Hoon, Doctor

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

Samyang Biopharmaceuticals

Seoul, , South Korea

Countries

South Korea

Other Identifiers

POP-SERATOM PA

Identifier Type: -

Identifier Source: org_study_id