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Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse

NCT ID: NCT02178735

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

Brief Summary

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To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

Detailed Description

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We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.

Conditions

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Pelvic Organ Prolapse

Keywords

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pelvic organ prolapse, vaginal mesh, urodynamic studies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anterior compartment prolapse

Woman with cystocele who underwent anterior vaginal tailored mesh surgery

Group Type EXPERIMENTAL

Anterior vaginal tailored mesh surgery

Intervention Type PROCEDURE

Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence

Posterior compartment prolapse

Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery

Group Type EXPERIMENTAL

Posterior vaginal tailored mesh surgery

Intervention Type PROCEDURE

Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

anterior and posterior prolapse

Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery

Group Type EXPERIMENTAL

Anterior vaginal tailored mesh surgery

Intervention Type PROCEDURE

Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence

Posterior vaginal tailored mesh surgery

Intervention Type PROCEDURE

Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

Interventions

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Anterior vaginal tailored mesh surgery

Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence

Intervention Type PROCEDURE

Posterior vaginal tailored mesh surgery

Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Locations

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Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.

Reference Type DERIVED
PMID: 26634203 (View on PubMed)

Other Identifiers

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201404024RINC

Identifier Type: -

Identifier Source: org_study_id