Vaginal Mesh Procedures for Female Cystocele

Study Overview
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Brief Summary
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This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Detailed Description
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Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Official Title
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Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele

Conditions
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Cystocele

Intervention / Treatment
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* Procedure: Vaginal mesh for female cystocele


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of cystocele Exclusion Criteria: Pregnancy or possibility of future pregnancy Urinary tract infection Diabetes Neurological diseases Cardiovascular diseases

Ages Eligible for Study
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Minimum Age: 240 Months

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women 20 years and older with cystocele<br>Women 20 years and older with cystocele | Procedure: Vaginal mesh for female cystocele<br>* Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POP-Q Ba point | POP-Q Ba > II POP-Q stage | Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and ultrasound manifestations | Urinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound | Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystocele, pelvic floor muscle exercise, anterior vaginal repair, vaginal mesh