- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320644
A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh (ALYTE)
August 10, 2016 updated by: charbel salamon, Atlantic Health System
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Morristown, New Jersey, United States, 07960
- Morristown Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
vaginal mesh placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
March 21, 2011
First Submitted That Met QC Criteria
March 21, 2011
First Posted (Estimate)
March 22, 2011
Study Record Updates
Last Update Posted (Estimate)
August 11, 2016
Last Update Submitted That Met QC Criteria
August 10, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R10-06-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
Hadassah Medical OrganizationCompletedUrinary Stress Incontinence (SI)Israel
-
University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
-
Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark