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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: Seratom® PA mesh

• Registration Number: NCT02320643
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Primary Completion: 2016-11
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seratom® PA mesh	Seratom® PA mesh	Partially absorbable mesh

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
No of patients complications occurred	For post op 6 months from baseline

Trial Locations

Locations (1)

Samyang Biopharmaceuticals; 🇰🇷 Seoul, Korea, Republic of