---
title: A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh in Patients With Pelvic Organ Prolapsed
nct_id: NCT02320643
overall_status: COMPLETED
phase: NA
sponsor: Samyang Biopharmaceuticals Corporation
study_type: INTERVENTIONAL
primary_condition: Pelvic Organ Prolapse
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02320643.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02320643"
ct_last_update_post_date: 2017-05-01
last_seen_at: "2026-05-12T06:46:53.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh in Patients With Pelvic Organ Prolapsed

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

**NCT ID:** [NCT02320643](https://clinicaltrials.gov/study/NCT02320643)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Samyang Biopharmaceuticals Corporation
- **Conditions:** Pelvic Organ Prolapse
- **Start Date:** 2014-12
- **Completion Date:** 2017-04
- **CT.gov Last Update:** 2017-05-01

## 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.

## Eligibility

- **Minimum age:** 41 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **Seratom® PA mesh** (EXPERIMENTAL) — Partially absorbable mesh

## Interventions

- **Seratom® PA mesh** (DEVICE) — Partially absorbable mesh

## Primary Outcomes

- **Pelvic Organ Prolapse Quantification(POP-Q) stage** _(time frame: Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week)_
- **Surgical revision rate** _(time frame: For post op 6 months from baseline)_

## Secondary Outcomes

- **No of patients complications occurred** _(time frame: For post op 6 months from baseline)_

## Locations (1)

- Samyang Biopharmaceuticals, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.samyang biopharmaceuticals|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02320643.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02320643*  
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