One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Urinary Incontinence Clinical Trial

Official title:

One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055860
• Other study ID #: R09-02-007
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: March 21, 2011
• Start date: February 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• 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 its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period

Exclusion Criteria:

• Other graft material than polypropylene.

• Enrollment in a different study.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Locations

Country	Name	City	State
United States	Atlantic Health 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	1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus		one year	No
Secondary	2. Prolapse Specific Quality of Life Patients will complete a prolapse specific quality of life instrument prior to and one year after surgery. (PFIQ-7)		one year	No
Secondary	3. Pelvic organ prolapse related symptoms (PFDI-20)		one year	No
Secondary	4. Graft-related complications Rates of graft erosion into adjacent organs such as bowel, bladder or vagina - during the study period will be reported.		one year	No