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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01055860
Enrollment
75
Registered
2010-01-26
Start date
2009-02-28
Completion date
2010-07-31
Last updated
2011-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Urinary Incontinence

Keywords

uterine Prolapse, vaginal prolapse, mesh erosion, urinary incontinence, bowel symptoms

Brief 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.

Interventions

None listed

Sponsors

Atlantic Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 introitusone year

Secondary

MeasureTime frame
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
3. Pelvic organ prolapse related symptoms (PFDI-20)one year
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026