Vaginal Mesh Procedures for Female Cystocele

Sponsor
Cathay General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04481906
Collaborator
(none)
160
1
35.4
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vaginal mesh for female cystocele

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 Design

Study Type:
Observational
Actual Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele
Study Start Date :
Oct 25, 2011
Actual Primary Completion Date :
Jun 16, 2012
Actual Study Completion Date :
Oct 5, 2014

Arms and Interventions

Arm Intervention/Treatment
Women 20 years and older with cystocele

Women 20 years and older with cystocele

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
240 Months and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cathay General Hospital Taipei Taiwan 10630

Sponsors and Collaborators

  • Cathay General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cathay General Hospital
ClinicalTrials.gov Identifier:
NCT04481906
Other Study ID Numbers:
  • CGH-P100072
First Posted:
Jul 22, 2020
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2018
Keywords provided by Cathay General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2020