NCT02178735

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

June 9, 2014

Last Update Submit

January 27, 2016

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, vaginal mesh, urodynamic studies

Outcome Measures

Primary Outcomes (1)

  • Recurrence of pelvic organ prolapse

    Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery

    1 year

Secondary Outcomes (3)

  • The change of pad weight

    3 months

  • The change of maximum urethral closure pressure

    3 months

  • Vaginal mesh erosion

    1 year

Study Arms (3)

Anterior compartment prolapse

EXPERIMENTAL

Woman with cystocele who underwent anterior vaginal tailored mesh surgery

Procedure: Anterior vaginal tailored mesh surgery

Posterior compartment prolapse

EXPERIMENTAL

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

Procedure: Posterior vaginal tailored mesh surgery

anterior and posterior prolapse

EXPERIMENTAL

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

Procedure: Anterior vaginal tailored mesh surgeryProcedure: Posterior vaginal tailored mesh surgery

Interventions

Anterior vaginal tailored mesh surgeryPROCEDURE

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

Anterior compartment prolapseanterior and posterior prolapse
Posterior vaginal tailored mesh surgeryPROCEDURE

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

Posterior compartment prolapseanterior and posterior prolapse

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 26634203DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ho-Hsiung Lin, MD, PhD

    Department of Obstetrics & Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

July 1, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

TW(1)