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
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, see Learn About Clinical Studies.

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
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Prolapse
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014