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Vaginal Mesh Procedures for Female Cystocele

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04481906
Enrollment
160
Registered
2020-07-22
Start date
2011-10-25
Completion date
2014-10-05
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele

Keywords

cystocele, pelvic floor muscle exercise, anterior vaginal repair, vaginal mesh

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.

Interventions

PROCEDUREVaginal mesh for female cystocele

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

Sponsors

Cathay General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
240 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Clinical diagnosis of cystocele

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
POP-Q Ba pointPreoperative, as well as postoperative 3 months, 12 months, and then anuuanllyPOP-Q Ba \> II POP-Q stage

Secondary

MeasureTime frameDescription
Functional and ultrasound manifestationsPreoperative, as well as postoperative 3 months, 12 months, and then anuuanllyUrinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026