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NCT01320644 Clinical Trial

A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh

Urinary Incontinence Clinical Trial

— ALYTE  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01320644
Other study ID # R10-06-005
Secondary ID
Status Completed
Phase N/A
First received March 21, 2011
Last updated August 10, 2016
Start date August 2010
Est. completion date August 2012

Study information
Verified date August 2016
Source Atlantic Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Any patient receiving Robotic assisted laparoscopic sacral copopexy with polypropylene mesh

- >21 y.o

Exclusion Criteria:

- Graft material other than polypropylene mesh

- Enrollment in another study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Morristown Memorial Hospital Morristown New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

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