- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982188
Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
August 10, 2016 updated by: charbel salamon, Atlantic Health System
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
104
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
- Atlantic Health System
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Our study population included all women undergoing single incision sling placement at the time of robotic sacrocolpopexy
Description
Inclusion Criteria:
- all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period
Exclusion Criteria:
- previous surgical treatment for stress urinary incontinence (SUI)
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 |
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Single incision sling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough Stress Test
Time Frame: 12 months post procedure
|
Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.
|
12 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mesh related complications
Time Frame: 12 months post procedure
|
possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period
|
12 months post procedure
|
Urinary Distress Inventory 6 (UDI-6)
Time Frame: baseline and 12 months postoperatively
|
This validated questionnaires will be given to subject to collect subjective data
|
baseline and 12 months postoperatively
|
Urinary Impact Questionnaire (UIQ-7)
Time Frame: baseline and 12 months postoperatively
|
this validated questionnaire will be completed by subject to collect subjective data
|
baseline and 12 months postoperatively
|
Sandvick Severity Index Questionnaire
Time Frame: baseline and 12 months postoperatively
|
This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence
|
baseline and 12 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charbel Salamon, MD, Atlantic Health System
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
September 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 31, 2013
First Submitted That Met QC Criteria
November 6, 2013
First Posted (Estimate)
November 13, 2013
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
- R12-09-001
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.
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