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

NCT02320643 | Completed

• 1 other identifier: POP-SERATOM PA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Partially absorbable mesh

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• No of patients complications occurred

  For post op 6 months from baseline

Study Arms (1)

Seratom® PA mesh

EXPERIMENTAL

Partially absorbable mesh

Device: Seratom® PA mesh

Interventions

Seratom® PA mesh DEVICE

Partially absorbable mesh

Seratom® PA mesh

Eligibility Criteria

• Age: 41 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Note: previous traditional repairs are allowed.
• Subjects who have had radiation therapy to the pelvic area
• 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
• Subjects who have a shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys.)
• Subjects who have a known neurologic or medical condition affecting bladder function (e.g. Multiple Sclerosis, spinal cord injury)

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Samyang Biopharmaceuticals

Seoul, South Korea

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kwon Sang Hoon, Doctor

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 19, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

KR (1)