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Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh (MPATHY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320618
First Posted: March 22, 2011
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
charbel salamon, Atlantic Health System
  Purpose
Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.

Condition
Pelvic Organ Prolapse Urinary Incontinence Mesh Erosion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by charbel salamon, Atlantic Health System:

Enrollment: 120
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Our study population will be woman who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapseusing synthetic polypropelene mesh.
Criteria

Inclusion Criteria:

  • Any patient receiving Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh

Exclusion Criteria:

  • Other graft material than polypropylene mesh
  • Enrollment in another study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: charbel salamon, Principal Investigator, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01320618     History of Changes
Other Study ID Numbers: R09-06-003
First Submitted: March 21, 2011
First Posted: March 22, 2011
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by charbel salamon, Atlantic Health System:
uterine prolapse
vaginal prolapse
mesh erosion
urinary incontinence
bowel symptoms

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical