NCT02465710

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

June 4, 2015

Last Update Submit

December 15, 2015

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapsepelvic floor reconstruction surgerytransvaginal mesh surgeryWomenSurgical treatment

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of pelvic organ prolapse

    follow-up till postoperative 5 years

    5 years

Study Arms (1)

pelvic organ prolapse

All women who underwent surgical treatment of pelvic organ prolapse in this study.

Procedure: Pelvic organ prolapse surgery without meshProcedure: Pelvic organ prolapse surgery with mesh

Interventions

Pelvic organ prolapse surgery without meshPROCEDURE

retrospective study

pelvic organ prolapse
Pelvic organ prolapse surgery with meshPROCEDURE
pelvic organ prolapse

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Central Study Contacts

Ho-Hsiung Lin, MD,PhD

CONTACT

886-2-23123456hhlin@ntuh.gov.tw

Sheng-Mou Hsiao

CONTACT

886-2-89667000smhsiao2@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 8, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

TW(1)