Back to resultsClinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Anterior vaginal tailored mesh surgery
Posterior vaginal tailored mesh surgery
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, vaginal mesh, urodynamic studies
Eligibility Criteria
Inclusion Criteria:
- All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013
Exclusion Criteria: nil
Sites / Locations
- Department of Obstetrics & Gynecology, National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Anterior compartment prolapse
Posterior compartment prolapse
anterior and posterior prolapse
Arm Description
Woman with cystocele who underwent anterior vaginal tailored mesh surgery
Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery
Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery
Outcomes
Primary Outcome Measures
Recurrence of pelvic organ prolapse
Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery
Secondary Outcome Measures
The change of pad weight
The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse
The change of maximum urethral closure pressure
The difference of maximum urethral closure pressure between baseline and 3 months after surgery
Vaginal mesh erosion
Vaginal mesh erosion rate within 1 year after surgery
Full Information
NCT ID
NCT02178735
First Posted
June 9, 2014
Last Updated
January 27, 2016
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02178735
Brief Title
Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
Official Title
Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.
Detailed Description
We will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at National Taiwan University Hospital between November 2011 and November 2013.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, vaginal mesh, urodynamic studies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior compartment prolapse
Arm Type
Experimental
Arm Description
Woman with cystocele who underwent anterior vaginal tailored mesh surgery
Arm Title
Posterior compartment prolapse
Arm Type
Experimental
Arm Description
Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery
Arm Title
anterior and posterior prolapse
Arm Type
Experimental
Arm Description
Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery
Intervention Type
Procedure
Intervention Name(s)
Anterior vaginal tailored mesh surgery
Intervention Description
Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
Intervention Type
Procedure
Intervention Name(s)
Posterior vaginal tailored mesh surgery
Intervention Description
Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse
Primary Outcome Measure Information:
Title
Recurrence of pelvic organ prolapse
Description
Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The change of pad weight
Description
The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse
Time Frame
3 months
Title
The change of maximum urethral closure pressure
Description
The difference of maximum urethral closure pressure between baseline and 3 months after surgery
Time Frame
3 months
Title
Vaginal mesh erosion
Description
Vaginal mesh erosion rate within 1 year after surgery
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in National Taiwan University Hospital between November 2011 and November 2013
Exclusion Criteria: nil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD
Organizational Affiliation
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynecology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26634203
Citation
Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse. Biomed Res Int. 2015;2015:191258. doi: 10.1155/2015/191258. Epub 2015 Nov 8.
Results Reference
derived
Learn more about this trial
Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
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