Vaginal Mesh Procedures for Female Cystocele

Completed

• Conditions: Cystocele
• Interventions: Procedure: Vaginal mesh for female cystocele

• Registration Number: NCT04481906
• Lead Sponsor: Cathay General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-10-25
• Primary Completion: 2012-06-16
• Study Completion: 2014-10-05
• Status Verified: 2018-07
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2020-07-19
• Last Update Submitted: 2020-07-19
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Clinical diagnosis of cystocele

Exclusion Criteria

• Pregnancy or possibility of future pregnancy
• Urinary tract infection
• Diabetes
• Neurological diseases
• Cardiovascular diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women 20 years and older with cystocele	Vaginal mesh for female cystocele	Women 20 years and older with cystocele

Primary Outcome Measures

Name	Time	Method
POP-Q Ba point	Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly	POP-Q Ba \> II POP-Q stage

Secondary Outcome Measures

Name	Time	Method
Functional and ultrasound manifestations	Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly	Urinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound

Trial Locations

Locations (1)

Cathay General Hospital; 🇨🇳 Taipei, Taiwan