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Surgical Outcomes of Vaginal Prolapse Repair With Elevate

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ClinicalTrials.gov Identifier: NCT01190618
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Larry Sirls, William Beaumont Hospitals

Brief Summary:
The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

Condition or disease
Vaginal Prolapse

Detailed Description:
The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.

Study Type : Observational
Actual Enrollment : 417 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit
Study Start Date : August 2010
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016



Primary Outcome Measures :
  1. Comparison of Outcomes [ Time Frame: 3 Months ]
    To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women having vaginal repair with Elevate prolapse repair kit
Criteria

Inclusion Criteria:

  • Women who have had a vaginal repair with Elevate prolapse repair kit

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190618


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Larry Sirls
Investigators
Principal Investigator: Larry Sirls, MD William Beaumont Hospitals

Responsible Party: Larry Sirls, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01190618     History of Changes
Other Study ID Numbers: 2010-176
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse