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NCT01559558 Clinical Trial

Changes of Pad Weight Results and Urethral Pressure Profiles After Reduction of Cystocele by Vaginal Gauze Packing

Cystocele Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01559558
Other study ID # 201104016RC
Secondary ID
Status Completed
Phase N/A
First received March 6, 2012
Last updated March 19, 2012
Start date March 2012
Est. completion date March 2012

Study information
Verified date March 2012
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients with >= stage II cystocele and underwent urodynamic studies

Exclusion Criteria:

- patients less than 20 patients

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• vaginal packing
vaginal packing after urodynamic studies, and repeat urethral pressure profile

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 The rate of anti-incontinence surgery in the follow-up period after cystocele repair using the criteria of pad weight > 8 gm after vaginal gauze packing in the initial urodynamic examinations as the indication of concomitant anti-incontinence surgery during cystocele repair. 5 years No
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