NCT01982188|CompletedDMC
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Sponsor study identifier
observational
104
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2013
Actual (reported)November 13, 2013
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)Cough Stress Test
Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.
12 months post procedure
mesh related complications
12 months post procedure
Urinary Distress Inventory 6 (UDI-6)
baseline and 12 months postoperatively
Urinary Impact Questionnaire (UIQ-7)
baseline and 12 months postoperatively
Sandvick Severity Index Questionnaire
baseline and 12 months postoperatively
Our study population included all women undergoing single incision sling placement at the time of robotic sacrocolpopexy
Atlantic Health System
Morristown, New Jersey, 07960, United States
Charbel Salamon, MD
Atlantic Health System
104 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2013
First Posted
November 13, 2013
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
August 11, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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