Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Pelvic organ prolapse surgery without mesh; Procedure: Pelvic organ prolapse surgery with mesh

• Registration Number: NCT02465710
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital.

Detailed Description

Hypothesis / aims of study:

The use of mesh for women with pelvic organ prolapsed (POP) remains under debate, despite a recent randomized trial reported a favourable anatomic outcome of transvaginal mesh (TVM) surgery for cystocele, compared with anterior colporrhaphy. Besides, the issue of preserving uterus or not in women with POP during operation is still undetermined. Thus, the aim of this study is to compare clinical outcomes of the novel tailored TVM surgeries and conventional transvaginal native tissue repair (NTR) surgeries for POP.

Study design, materials and methods:

Between November 2011 and September 2014, the medical records of all consecutive women who underwent POP surgeries in a medical centre were reviewed. The choice of surgery method was according to the surgeons' preference. Clinical characteristics and intraoperative data and postoperative clinical outcomes were recorded. Wilcoxon rank-sum test was used to compare the data between two groups. Kaplan-Meier survival analysis was used to compare the recurrence rate between two groups.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
• ≥ 20 years old female.

Exclusion Criteria

• Healthy women
• Without underwent surgical treatment of pelvic organ prolapse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pelvic organ prolapse	Pelvic organ prolapse surgery without mesh	All women who underwent surgical treatment of pelvic organ prolapse in this study.
pelvic organ prolapse	Pelvic organ prolapse surgery with mesh	All women who underwent surgical treatment of pelvic organ prolapse in this study.

Primary Outcome Measures

Name	Time	Method
Recurrence rate of pelvic organ prolapse	5 years	follow-up till postoperative 5 years

Trial Locations

Locations (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan