Stress Urinary IncontinenceNCT00463554
TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
An observational study of Stress Urinary Incontinence, run by Ethicon, Inc. at 6 sites in 3 countries.
Trial summary
The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- GYNECARE TVT-SECUR* System
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Apr 2006to 1 Dec 2007
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with stress urinary incontinence
Who may be able to join
- Must be female with objective, demonstratable signs of SUI or stress predominant mixed incontinence and requires elective, primary surgical intervention.
- Must be at least 21 years old.
- Must be postmenopausal (amenorrhea) for at least 1 year or surgically sterile (bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy) or has a negative pregnancy test prior to study entry and has decided to cease childbearing.
- Agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB/EC-approved informed consent
Who cannot join
- Have any other coexistent pathology requiring concomitant surgery that may impact this procedure i.e. surgeries that involve the anterior vaginal wall (e.g. anterior colporrhaphy, diverticula, anterior Prolift) Any allowable concomitant surgery must be performed prior to the GYNECARE TVT SECUR System surgery.
- Have intrinsic sphincter deficiency (ISD) [Urethral Pressure Profile (UPP) with a maximum urethral closing pressure (MUCP) < 20cm H2O or Leak Point Pressure (LPP) < 60].
- Have an active urinary tract infection (UTI) or vaginal infection at time of surgery.
- Have a fixed urethra (< 30° mobility on Q-Tip Straining Test).
- Have had prior incontinence surgery.
- Have a post-void residual volume > 100mL.
Show all 13Show fewer
- Have co-existent pelvic organ prolapse that is symptomatic or extends beyond the hymen.
- Have lower urinary tract pathology in the form of a fistula or diverticulum.
- Have a malignancy or with a history of malignancy within the past 5 years, except for a basal cell carcinoma that has been treated with local excision and is no longer present.
- Are on anticoagulant therapy.
- Have received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment.
- Are deemed by the investigator as medically unfit for surgery or who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the GYNECARE TVT SECUR System IFU.
- Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18104
Good Samaritan Hospital
Cincinnati, Ohio, 45220-2489
Michigan Institute of Women's Health
Dearborn, Michigan, 48124
Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: An Evaluation of the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).
Read the detailed description
The primary variable for effectiveness is > 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.
- Conditions
- Stress Urinary Incontinence
- Being tested
- GYNECARE TVT-SECUR* System
- Keywords
- Incontinence, Stress Urinary
- 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-SECUR* SystemDevice
Also called Sub-urethral sling
A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of TVT-SECUR*
Measured: Screening and Day 35
Secondary outcomes (8)
Assessment of the results of the standing cough stress test
Measured: Screening, Week 5, Months 6 and 12
Intra- and post-operative complications
Measured: Intraoperative, Week 5, Months 6 and 12
Physician questionnaire results
Measured: Months 2 and 12
Urodynamics
Measured: Screening, Week 5, Months 6 and 12 (post-operative optional)
QoL measures
Measured: Screening, Week 5, Months 6 and 12
Subject satisfaction.
Measured: Month 12
Anesthesia
Measured: intraoperative
Operative time
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study start1 Apr 2006
- Primary completion1 Jan 2007
- Study completion1 Dec 2007
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.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Robinson, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463554
- Sponsor's protocol ID
- 300-05-002
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2007
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
- ClinicalTrials.gov ID
- NCT00463554
- Acronym / sponsor ID
- 300-05-002
- Conditions
- Stress Urinary Incontinence
- Keywords
- Incontinence, Stress Urinary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 1 Jan 2007 (actual)
- Study completion
- 1 Dec 2007 (actual)
- First posted
- 20 Apr 2007 (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.
The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).
Detailed description
The primary variable for effectiveness is > 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with stress urinary incontinence
Key inclusion criteria (4 listed)
- Must be female with objective, demonstratable signs of SUI or stress predominant mixed incontinence and requires elective, primary surgical intervention.
- Must be at least 21 years old.
- Must be postmenopausal (amenorrhea) for at least 1 year or surgically sterile (bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy) or has a negative pregnancy test prior to study entry and has decided to cease childbearing.
- Agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB/EC-approved informed consent
Key exclusion criteria (13 listed)
- Have any other coexistent pathology requiring concomitant surgery that may impact this procedure i.e. surgeries that involve the anterior vaginal wall (e.g. anterior colporrhaphy, diverticula, anterior Prolift) Any allowable concomitant surgery must be performed prior to the GYNECARE TVT SECUR System surgery.
- Have intrinsic sphincter deficiency (ISD) [Urethral Pressure Profile (UPP) with a maximum urethral closing pressure (MUCP) < 20cm H2O or Leak Point Pressure (LPP) < 60].
- Have an active urinary tract infection (UTI) or vaginal infection at time of surgery.
- Have a fixed urethra (< 30° mobility on Q-Tip Straining Test).
- Have had prior incontinence surgery.
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-SECUR* SystemAlso: Sub-urethral slingA sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency | Device | – |
Primary outcome
Clinical performance of TVT-SECUR*
Time frame: Screening and Day 35
8 secondary outcomes
Assessment of the results of the standing cough stress test
Time frame: Screening, Week 5, Months 6 and 12
Intra- and post-operative complications
Time frame: Intraoperative, Week 5, Months 6 and 12
Physician questionnaire results
Time frame: Months 2 and 12
Urodynamics
Time frame: Screening, Week 5, Months 6 and 12 (post-operative optional)
QoL measures
Time frame: Screening, Week 5, Months 6 and 12
Subject satisfaction.
Time frame: Month 12
Anesthesia
Time frame: intraoperative
Operative time
Time frame: Intraoperative
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 23 Aug 2023.
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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.
David Robinson, MD study director
Ethicon, Inc.
6 sites in 3 countries: 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 Ethicon, Inc. at 6 sites in 3 countries.
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 4 inclusion and 13 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Finland, Italy. 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?
Clinical performance of TVT-SECUR* (time frame: Screening and Day 35). 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 23 Aug 2023.