NCT01320644

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

March 21, 2011

Last Update Submit

August 10, 2016

Conditions

Pelvic Organ ProlapseUrinary IncontinenceMesh Erosion

Keywords

Uterine prolapsevaginal prolapsemesh erosionurinary incontinencebowel symptoms

Study Arms (1)

vaginal mesh placement

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be woman who underwent robotic assisted laparoscopic sacral colpopexy at Morristown Memorial Hospital for the correction of pelvic organ prolapse using synthetic polypropylene mesh

You may qualify if:

  • Any patient receiving Robotic assisted laparoscopic sacral copopexy with polypropylene mesh
  • \>21 y.o

You may not qualify if:

  • Graft material other than polypropylene mesh
  • Enrollment in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary IncontinenceUterine Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsUterine DiseasesGenital Diseases, FemaleGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

US(1)