Clinical trial NCT02320643: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Partially absorbable mesh
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification(POP-Q) stage
timeFrame: Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week
measure: Surgical revision rate
timeFrame: For post op 6 months from baseline
Secondary outcomes:
measure: No of patients complications occurred
timeFrame: For post op 6 months from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samyang Biopharmaceuticals
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Kwon Sang Hoon, Doctor
role: PRINCIPAL_INVESTIGATOR
References: