Stress Urinary Incontinence (SUI)NCT01982188
Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
An observational study of Stress Urinary Incontinence (SUI), run by Atlantic Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Our study population included all women undergoing single incision sling placement at the time of robotic sacrocolpopexy
Who may be able to join
- all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period
Who cannot join
- previous surgical treatment for stress urinary incontinence (SUI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- single incision sling, cough stress test, MiniArc, UDI-6, UIQ-7, Sandvick Severity Index (SSI)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single incision sling | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Stress Test
Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.
Measured: 12 months post procedure
Secondary outcomes (4)
mesh related complications
possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period
Measured: 12 months post procedure
Urinary Distress Inventory 6 (UDI-6)
This validated questionnaires will be given to subject to collect subjective data
Measured: baseline and 12 months postoperatively
Urinary Impact Questionnaire (UIQ-7)
this validated questionnaire will be completed by subject to collect subjective data
Measured: baseline and 12 months postoperatively
Sandvick Severity Index Questionnaire
This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence
Measured: baseline and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, charbel salamon, Atlantic Health System
- Investigators
- Charbel Salamon, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982188
- Sponsor's protocol ID
- R12-09-001
- Status last verified
- Aug 2016
- First submitted
- 31 Oct 2013
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT01982188
- Acronym / sponsor ID
- R12-09-001
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- single incision sling, cough stress test, MiniArc, UDI-6, UIQ-7, Sandvick Severity Index (SSI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single incision sling | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our study population included all women undergoing single incision sling placement at the time of robotic sacrocolpopexy
Key inclusion criteria (1 listed)
- all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period
Key exclusion criteria (1 listed)
- previous surgical treatment for stress urinary incontinence (SUI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cough Stress Test
Time frame: 12 months post procedure
Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.
4 secondary outcomes
mesh related complications
Time frame: 12 months post procedure
Urinary Distress Inventory 6 (UDI-6)
Time frame: baseline and 12 months postoperatively
Urinary Impact Questionnaire (UIQ-7)
Time frame: baseline and 12 months postoperatively
Sandvick Severity Index Questionnaire
Time frame: baseline and 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charbel Salamon, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence (SUI), run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough Stress Test (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.