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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01559558
First received: March 6, 2012
Last updated: March 19, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559558

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

No publications provided

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
Study First Received: March 6, 2012
Last Updated: March 19, 2012
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014