Vaginal Mesh Procedures for Female Cystocele

Cystocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481906
• Other study ID #: CGH-P100072
• Status: Completed
• Start date: October 25, 2011
• Est. completion date: October 5, 2014

Study information

• Verified date: July 2018
• Source: Cathay General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 5, 2014
• Est. primary completion date: June 16, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 240 Months and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cystocele

Exclusion Criteria:

• Pregnancy or possibility of future pregnancy

• Urinary tract infection

• Diabetes

• Neurological diseases

• Cardiovascular diseases

Related Conditions & MeSH terms

• Cystocele
• Hernia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POP-Q Ba point	POP-Q Ba > II POP-Q stage	Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
Secondary	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