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Completed

NCT Number: NCT02320643

A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh 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.

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Key information

Age range

41 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samyang Biopharmaceuticals

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Subjects who have a known hypersensitivity to the graft material(s)

Treatment and study plan

Seratom® PA mesh

Device

Partially absorbable mesh

Primary outcomes

  1. 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

  2. Surgical revision rate

    Time frame: For post op 6 months from baseline

Secondary outcomes

  1. No of patients complications occurred

    Time frame: For post op 6 months from baseline

Sponsors and collaborators

Lead sponsor

Samyang Biopharmaceuticals Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 19, 2014
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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