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Clinical Trials/NCT04481906
NCT04481906
Completed
Not Applicable

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

Cathay General Hospital1 site in 1 country160 target enrollmentOctober 25, 2011
ConditionsCystocele

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystocele
Sponsor
Cathay General Hospital
Enrollment
160
Locations
1
Primary Endpoint
POP-Q Ba point
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2011
End Date
October 5, 2014
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of cystocele

Exclusion Criteria

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

Outcomes

Primary Outcomes

POP-Q Ba point

Time Frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

POP-Q Ba \> II POP-Q stage

Secondary Outcomes

  • Functional and ultrasound manifestations(Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly)

Study Sites (1)

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