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NCT00774215 Clinical Trial

Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year

Pelvic Organ Prolapse Clinical Trial

Official title:
Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00774215
Other study ID # R07-09-016
Secondary ID
Status Completed
Phase N/A
First received October 16, 2008
Last updated January 25, 2010
Start date October 2007
Est. completion date April 2009

Study information
Verified date October 2008
Source Atlantic Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.

Description:

This is a retrospective cohort analysis of all patients who experienced vaginal prolapse and were operated on with the Avaulta synthetic vaginal mesh "kit" from January 2006 to April 2007. The Avaulta synthetic mesh is composed of polypropylene which is a monofilament. The objective of this trial is to compare patients objectively and subjectively at least one year after placement of the Avaulta synthetic vaginal mesh in terms of prolapse symptoms.

This data will be compared to pre-operative data already collected for these patients as a part of their routine surgical work-up. Mesh-related complications will be quantified, including erosions, new-onset pain, and infections. Success and anatomic recurrence rates will be recorded as well

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.

Exclusion Criteria:

- Unable to give informed consent to participate

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Atlantic Health System - Division of Urogynecology Morristown New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit 1 year post operatively No
Secondary Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit 1 year No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05422209 - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. N/A
Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT06126328 - Materna Prep Study Phase II Phase 2
Recruiting NCT05542836 - EVeRLAST 2-Year Follow-Up
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
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
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A

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