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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320643
• Other study ID #: POP-SERATOM PA
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: April 27, 2017
• Start date: December 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Samyang Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 41 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Seratom® PA mesh
Partially absorbable mesh

Locations

Country	Name	City	State
Korea, Republic of	Samyang Biopharmaceuticals	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Organ Prolapse Quantification(POP-Q) stage		Change from baseline in Pelvic Organ Prolapse Quantification(POP-Q) stage at postop 2week, 12week, 24week
Primary	Surgical revision rate		For post op 6 months from baseline
Secondary	No of patients complications occurred		For post op 6 months from baseline