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NCT01190618 Clinical Trial

Surgical Outcomes of Vaginal Prolapse Repair With Elevate

Vaginal Prolapse Clinical Trial

Official title:
Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01190618
Other study ID # 2010-176
Secondary ID
Status Completed
Phase N/A
First received August 26, 2010
Last updated February 14, 2017
Start date August 2010
Est. completion date December 31, 2016

Study information
Verified date February 2017
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. .

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.

Recruitment information / eligibility
Status Completed
Enrollment 417
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
Larry Sirls

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of Outcomes 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. 3 Months
See also
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Completed NCT00388947 - Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products N/A
Active, not recruiting NCT00442247 - A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse N/A
Not yet recruiting NCT04078802 - 0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse N/A
Recruiting NCT00918099 - The Use of Avaulta for Anterior Repair N/A
Completed NCT00769054 - Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study Phase 4
Completed NCT03187574 - Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse N/A
Completed NCT00679276 - Treatment Outcomes of Vaginal Prolapse Repair N/A
Completed NCT03338400 - Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role? Phase 2
Completed NCT00153231 - Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair Phase 4
Completed NCT01409902 - Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue N/A
Completed NCT00557882 - Efficacy Study of Vaginal Mesh for Anterior Prolapse Phase 4
Completed NCT00196495 - Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse Phase 4
Not yet recruiting NCT06234449 - The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Active, not recruiting NCT03658395 - Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms N/A
Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Completed NCT00475540 - Efficacy Study of Vaginal Mesh for Prolapse N/A
Enrolling by invitation NCT00571350 - Anterior Vaginal Wall Reconstruction Phase 1/Phase 2
Not yet recruiting NCT03333811 - Sexual Function After Vaginal Repair With Perineorrhaphy N/A