NCT04481906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
2 years until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

July 16, 2018

Last Update Submit

July 19, 2020

Conditions

Cystocele

Keywords

cystocelepelvic floor muscle exerciseanterior vaginal repairvaginal mesh

Outcome Measures

Primary Outcomes (1)

  • POP-Q Ba point

    POP-Q Ba \> II POP-Q stage

    Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

Secondary Outcomes (1)

  • Functional and ultrasound manifestations

    Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly

Study Arms (1)

Women 20 years and older with cystocele

Women 20 years and older with cystocele

Procedure: Vaginal mesh for female cystocele

Interventions

Vaginal mesh for female cystocelePROCEDURE

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

Women 20 years and older with cystocele

Eligibility Criteria

Age240 Months+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women 20 years or older with cystocele

You may qualify if:

  • Clinical diagnosis of cystocele

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cathay General Hospital

Taipei, 10630, Taiwan

Location

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

July 22, 2020

Study Start

October 25, 2011

Primary Completion

June 16, 2012

Study Completion

October 5, 2014

Last Updated

July 22, 2020

Record last verified: 2018-07

Locations

TW(1)