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

Phase 4

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Anterior vaginal tailored mesh surgery; Procedure: Posterior vaginal tailored mesh surgery

• Registration Number: NCT02178735
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-07-01
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

Exclusion Criteria

nil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior and posterior prolapse	Anterior vaginal tailored mesh surgery	Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery
Anterior compartment prolapse	Anterior vaginal tailored mesh surgery	Woman with cystocele who underwent anterior vaginal tailored mesh surgery
Posterior compartment prolapse	Posterior vaginal tailored mesh surgery	Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery
anterior and posterior prolapse	Posterior vaginal tailored mesh surgery	Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery

Primary Outcome Measures

Name	Time	Method
Recurrence of pelvic organ prolapse	1 year	Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
Vaginal mesh erosion	1 year	Vaginal mesh erosion rate within 1 year after surgery
The change of pad weight	3 months	The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse
The change of maximum urethral closure pressure	3 months	The difference of maximum urethral closure pressure between baseline and 3 months after surgery

Trial Locations

Locations (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan