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

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ClinicalTrials.gov Identifier: NCT01559558
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cystocele Procedure: vaginal packing

Study Design

Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : March 2012
Primary Completion Date : March 2012
Study Completion Date : March 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
cystocele Procedure: vaginal packing
vaginal packing after urodynamic studies, and repeat urethral pressure profile


Outcome Measures

Primary Outcome Measures :
  1. Changes of pad weight and values of urethral pressure profiles after vaginal gauze packing. [ Time Frame: 1 day ]
    Changes of pad weight and values of urethral pressure profiles between before and after vaginal gauze packing


Secondary Outcome Measures :
  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 [ Time Frame: 5 years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with >/= stage II cystocle
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients less than 20 patients
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559558


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
More Information

Responsible Party: National Taiwan University Hospital, Ho-Hsiung Lin, Professor of Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT01559558     History of Changes
Other Study ID Numbers: 201104016RC
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Cystocele
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical