Vaginal Mesh Procedures for Female Cystocele

NCT ID: NCT04481906

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-25
• Study Completion Date: 2014-10-05

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.

Conditions

Cystocele

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women 20 years and older with cystocele

Women 20 years and older with cystocele

Vaginal mesh for female cystocele

Intervention Type: PROCEDURE

Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele

Interventions

Vaginal mesh for female cystocele

Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of cystocele

Exclusion Criteria

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

• Minimum Eligible Age: 240 Months
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cathay General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cathay General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

CGH-P100072

Identifier Type: -

Identifier Source: org_study_id