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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02465710
• Other study ID #: 201504023RINC
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: December 15, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: National Taiwan University Hospital
• Contact: Ho-Hsiung Lin, MD,PhD
• Phone: 886-2-23123456
• Email: hhlin[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Pelvic organ prolapse surgery without mesh
retrospective study
• Pelvic organ prolapse surgery with mesh

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics & Gynecology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of pelvic organ prolapse	follow-up till postoperative 5 years	5 years	No