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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02465710
Enrollment
350
Registered
2015-06-08
Start date
2015-04-30
Completion date
2016-04-30
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, pelvic floor reconstruction surgery, transvaginal mesh surgery, Women, Surgical treatment

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.

Interventions

PROCEDUREPelvic organ prolapse surgery without mesh

retrospective study

PROCEDUREPelvic organ prolapse surgery with mesh

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate of pelvic organ prolapse5 yearsfollow-up till postoperative 5 years

Countries

Taiwan

Contacts

Primary ContactHo-Hsiung Lin, MD,PhD
hhlin@ntuh.gov.tw886-2-23123456
Backup ContactSheng-Mou Hsiao
smhsiao2@gmail.com886-2-89667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026