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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02178735
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 3
• Duration (Months): 18
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Anterior vaginal tailored mesh surgery; Procedure: Posterior vaginal tailored mesh surgery	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anterior compartment prolapse Woman with cystocele who underwent anterior vaginal tailored mesh surgery	Procedure: Anterior vaginal tailored mesh surgery; Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
Experimental: Posterior compartment prolapse Woman with rectocele, enterocele, uterine prolapse, vaginal stump prolpase who underwent posterior vaginal tailored mesh surgery	Procedure: Posterior vaginal tailored mesh surgery; Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse
Experimental: anterior and posterior prolapse Woman with cystocele and rectocele/uterine prolapse/vaginal vault prolapse/enterocele who underwent anterior and posterior vaginal tailored mesh surgery	Procedure: Anterior vaginal tailored mesh surgery; Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence; Procedure: Posterior vaginal tailored mesh surgery; Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse

Outcome Measures

Primary Outcome Measures

1. Recurrence of pelvic organ prolapse [1 year]

   Recurrence rate of cystocele, rectocele, uterine prolapse, or vaginal vault prolapse within 1 year after surgery

Secondary Outcome Measures

1. The change of pad weight [3 months]

   The change of pad weight between baseline and 3 months after surgery for pelvic organ prolapse

2. The change of maximum urethral closure pressure [3 months]

   The difference of maximum urethral closure pressure between baseline and 3 months after surgery

3. Vaginal mesh erosion [1 year]

   Vaginal mesh erosion rate within 1 year after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics & Gynecology, National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Ho-Hsiung Lin, MD, PhD, Department of Obstetrics & Gynecology, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT02178735
• Other Study ID Numbers: 201404024RINC
• First Posted: Jul 1, 2014
• Last Update Posted: Jan 29, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by National Taiwan University Hospital: pelvic organ prolapse, vaginal mesh, urodynamic studies
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Jan 29, 2016