- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01029106
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoints are the cure/improvement rate in the cohort at 12 months.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distribution of percentage of subjects having a decrease of pad weight as compared to baseline
Time Frame: 24 months
|
24 months
|
Decrease in number of pads used within a 24-hour period as compared to baseline
Time Frame: 24 months
|
24 months
|
Change in patient questionnaires from baseline
Time Frame: 24 months
|
24 months
|
Change in the sling position on transvaginal ultrasound
Time Frame: 24 months
|
24 months
|
Cure/improvement rate at 24 months
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TVTSecur
- 047-2009
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.
Clinical Trials on Stress Urinary Incontinence
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
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Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
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Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
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Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
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University Magna GraeciaUnknownStress Urinary IncontinenceItaly
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University of California, IrvineWithdrawnStress Urinary IncontinenceUnited States
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Eli Lilly and CompanyBoehringer IngelheimCompleted
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Eli Lilly and CompanyBoehringer IngelheimCompletedUrinary Stress IncontinenceUnited States
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GT Urological, LLCCompletedMale Stress Urinary IncontinenceAustralia, Czechia, New Zealand
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Zekai Tahir Burak Women's Health Research and Education...CompletedFemale Urinary Stress IncontinenceTurkey
Clinical Trials on Gynecare TVT Secur
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University of CalgaryUniversity of Alberta; Johnson & Johnson Medical CompaniesTerminatedUrinary Incontinence, StressCanada
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Federal University of São PauloJohnson & JohnsonCompletedStress Urinary IncontinenceBrazil
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Michigan Institution of Women's Health PCEthicon, Inc.CompletedUrinary Incontinence | Stress Urinary IncontinenceUnited States
-
Ethicon, Inc.CompletedStress Urinary IncontinenceUnited States, Italy, Finland
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Boston Urogynecology AssociatesUnknownStress Urinary IncontinenceUnited States
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The Cleveland ClinicDuke University; Medstar Health Research Institute; Women and Infants Hospital... and other collaboratorsCompletedStress Urinary IncontinenceUnited States
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Samsung Medical CenterCompletedMixed Urinary IncontinenceKorea, Republic of
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University of North Carolina, Chapel HillActive, not recruiting
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HaEmek Medical Center, IsraelUnknownPelvic Organ ProlapseIsrael
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University Magna GraeciaCompletedUrinary IncontinenceItaly