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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.

Sponsor: National Taiwan University Hospital

Current Primary Outcome: Recurrence rate of pelvic organ prolapse [ Time Frame: 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Taiwan University Hospital

Dates:
Date Received: June 4, 2015
Date Started: April 2015
Date Completion: April 2016
Last Updated: December 15, 2015
Last Verified: December 2015