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

Study Overview
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Anterior vaginal tailored mesh surgery
* Procedure: Posterior vaginal tailored mesh surgery


Participation Criteria
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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 Exclusion Criteria: nil

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior compartment prolapse<br>Woman with cystocele who underwent anterior vaginal tailored mesh surgery | Procedure: Anterior vaginal tailored mesh surgery<br>* Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence<br>|
| Experimental: Posterior compartment prolapse<br>Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery | Procedure: Posterior vaginal tailored mesh surgery<br>* Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse<br>|
| Experimental: anterior and posterior prolapse<br>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 surgery<br>* Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence<br>Procedure: Posterior vaginal tailored mesh surgery<br>* Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of pelvic organ prolapse | Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of pad weight | The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse | 3 months | 
| The change of maximum urethral closure pressure | The difference of maximum urethral closure pressure between baseline and 3 months after surgery | 3 months | 
| Vaginal mesh erosion | Vaginal mesh erosion rate within 1 year after surgery | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, vaginal mesh, urodynamic studies