We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559558
First Posted: March 21, 2012
Last Update Posted: March 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
The purpose of this study is to retrospectively review the impact of vaginal packing on the urodynamic studies, especially for urethral pressure profiles.

Condition Intervention
Cystocele Procedure: vaginal packing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 140
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cystocele Procedure: vaginal packing
vaginal packing after urodynamic studies, and repeat urethral pressure profile

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: March 6, 2012
First Posted: March 21, 2012
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