Stress Urinary IncontinenceNCT01029106
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
An observational study of Stress Urinary Incontinence, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Gynecare TVT Secur
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Sep 2012
- 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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 125 women with SUI from 5 centres across Canada will participate in this study.
Who may be able to join
- To be considered eligible to participate in this study, subjects must meet the following requirements:
- Subject has agreed to undergo surgical implantation of the TVT SECUR System
- Subject has the complaint of SUI for at least 6 months prior to the Preoperative Evaluation Visit.
- Subject has confirmed SUI resulting from urethral hypermobility on cough stress testing.
- Subject has at least 4 gm of urine leakage on 1-hour pad testing during the Preoperative Screening Visit.
- Subject is at least 18 years of age to maximum of 85 years of age
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- Subject is willing and able to give written informed consent prior to any study related procedures.
- Subject is willing to return for follow-up evaluation and questionnaire completion at 4-6 weeks, and at 3, 6, 12 and 24 month follow-ups.
- Subject is willing to undergo transvaginal ultrasound evaluation at the 4 weeks and 12 month follow-up visit.
Who cannot join
- Subjects will not be eligible for entry into the study if they meet one of the following criteria:
- Subject is pregnant.
- Subject has had any previous synthetic sub-urethral sling procedure.
- Subject has current urinary tract or vaginal infections.
- Subject has blood coagulation disorders.
- Subject has a compromised immune system or any other conditions that would compromise healing.
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- Subject has upper urinary tract obstruction.
- Subject is unwilling to provide written informed consent.
- Subject is unwilling or unable to return for evaluation at 4-6 weeks, and at 3, 6, 12, and 24 months.
- Subject has uncontrolled detrusor overactivity.
- Subject has PVR greater than 100 cc.
- Subject has Peak Flow Rate less than 10 ml/sec.
- Subject has urethral diverticulum.
- Subject has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
- Subject has had radiation therapy to the pelvic area at any time.
- Subject has current or active history of pelvic cancer.
- Subject who in the opinion of the investigator is unable and/or unlikely to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence
This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure.
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected.
Read more
Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing.
To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Gynecare TVT Secur
- Keywords
- SUI, Stress Urinary Incontinence, Patients with Stress Urinary Incontinence
- 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.
Gynecare TVT SecurProcedure or surgery
Implant of the Gynecare TVT Secur
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints are the cure/improvement rate in the cohort at 12 months.
Measured: 12 months
Secondary outcomes (5)
Distribution of percentage of subjects having a decrease of pad weight as compared to baseline
Measured: 24 months
Decrease in number of pads used within a 24-hour period as compared to baseline
Measured: 24 months
Change in patient questionnaires from baseline
Measured: 24 months
Change in the sling position on transvaginal ultrasound
Measured: 24 months
Cure/improvement rate at 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
Why it stopped: Study design required a change in device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Sender Herschorn, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029106
- Sponsor's protocol ID
- TVTSecur
- Other IDs
- 047-2009
- Status last verified
- Jul 2011
- First submitted
- 19 Oct 2009
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01029106
- Acronym / sponsor ID
- TVTSecur
- Conditions
- Stress Urinary Incontinence
- Keywords
- SUI, Stress Urinary Incontinence, Patients with Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study design required a change in device
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- First posted
- 9 Dec 2009 (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 is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure.
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected.
Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing.
To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 125 women with SUI from 5 centres across Canada will participate in this study.
Key inclusion criteria (9 listed)
- To be considered eligible to participate in this study, subjects must meet the following requirements:
- Subject has agreed to undergo surgical implantation of the TVT SECUR System
- Subject has the complaint of SUI for at least 6 months prior to the Preoperative Evaluation Visit.
- Subject has confirmed SUI resulting from urethral hypermobility on cough stress testing.
- Subject has at least 4 gm of urine leakage on 1-hour pad testing during the Preoperative Screening Visit.
Key exclusion criteria (17 listed)
- Subjects will not be eligible for entry into the study if they meet one of the following criteria:
- Subject is pregnant.
- Subject has had any previous synthetic sub-urethral sling procedure.
- Subject has current urinary tract or vaginal infections.
- Subject has blood coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynecare TVT SecurImplant of the Gynecare TVT Secur | Procedure or surgery | – |
Primary outcome
The primary endpoints are the cure/improvement rate in the cohort at 12 months.
Time frame: 12 months
5 secondary outcomes
Distribution of percentage of subjects having a decrease of pad weight as compared to baseline
Time frame: 24 months
Decrease in number of pads used within a 24-hour period as compared to baseline
Time frame: 24 months
Change in patient questionnaires from baseline
Time frame: 24 months
Change in the sling position on transvaginal ultrasound
Time frame: 24 months
Cure/improvement rate at 24 months
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Study design required a change in device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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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.
Sender Herschorn, MD principal investigator
Sunnybrook Health Sciences Centre
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, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 28 Jul 2011. 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 Canada. 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 was stopped early (reason given: Study design required a change in device). Results are not available in the source record.
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?
The primary endpoints are the cure/improvement rate in the cohort at 12 months. (time frame: 12 months). 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 28 Jul 2011.