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NCT02178735 Clinical Trial

Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02178735
Other study ID # 201404024RINC
Secondary ID
Status Completed
Phase Phase 4
First received June 9, 2014
Last updated January 27, 2016
Start date May 2014
Est. completion date November 2015

Study information
Verified date January 2016
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 99 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Anterior vaginal tailored mesh surgery
Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
• Posterior vaginal tailored mesh surgery
Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

Locations
Country Name City State
Taiwan Department of Obstetrics & Gynecology, National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence of pelvic organ prolapse Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery 1 year No
Secondary The change of pad weight The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse 3 months No
Secondary The change of maximum urethral closure pressure The difference of maximum urethral closure pressure between baseline and 3 months after surgery 3 months No
Secondary Vaginal mesh erosion Vaginal mesh erosion rate within 1 year after surgery 1 year Yes
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Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
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