NCT01559558

Brief Summary

The purpose of this study is to retrospectively review the impact of vaginal packing on the urodynamic studies, especially for urethral pressure profiles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

Same day

First QC Date

March 6, 2012

Last Update Submit

March 19, 2012

Conditions

Cystocele

Outcome Measures

Primary Outcomes (1)

  • Changes of pad weight and values of urethral pressure profiles after vaginal gauze packing.

    Changes of pad weight and values of urethral pressure profiles between before and after vaginal gauze packing

    1 day

Secondary Outcomes (1)

  • The rate of anti-incontinence surgery using the criteria of pad weight > 8 gm after vaginal gauze packing as the indication of concomitant anti-incontinence surgery during cystocele repair

    5 years

Study Arms (1)

cystocele

Procedure: vaginal packing

Interventions

vaginal packingPROCEDURE

vaginal packing after urodynamic studies, and repeat urethral pressure profile

cystocele

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with \>/= stage II cystocle

You may qualify if:

  • patients with \>= stage II cystocele and underwent urodynamic studies

You may not qualify if:

  • patients less than 20 patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, 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
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ho-Hsiung Lin, Professor of Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 21, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations

TW(1)