Urinary IncontinenceTVTSOfficeNCT01137539
TVT-SECUR as an Office-based Procedure
A study testing Gynecare TVT-SECUR system in people with Urinary Incontinence and Stress Urinary Incontinence, run by Michigan Institution of Women's Health PC at 1 site in United States.
Trial summary
This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires. Read more about this study
- Who is it for?
- Ages 21 to 89 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress Urinary Incontinence
- What is being tested?
- Gynecare TVT-SECUR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress urinary incontinence with hypermobility of the UV junction
- ASA I or II
- Age 21-89
Who cannot join
- Prior anti-incontinence surgery
- Not completed childbearing
- ASA III or higher
- Need concomitant surgery
- Poor compliance for office based approach
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Urogynecology of Michigan PC
Dearborn, Michigan, 48124
About this study
Official title: TVT-SECUR as an Office-based Procedure - A Pilot Study
This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.
This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
Read the detailed description
The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence
- Being tested
- Gynecare TVT-SECUR system
- Keywords
- urinary incontinence, stress urinary incontinence, mid-urethral slings, Tension-free vaginal taping, TVT
- Medical subject headings
- Urinary Incontinence, 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 TVT-S, Mid-urethral sling
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Gynecare TVT-SECUR system | Experimental | All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence Receives: Device: Gynecare TVT-SECUR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Based on Patient Report on Validated Questionnaire
Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.
Measured: 24 months
Secondary outcomes (1)
Patient Satisfaction
Positive response to a satisfaction question
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Institution of Women's Health PC
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Salil Khandwala MD, Michigan Institution of Women's Health PC
- Investigators
- Salil S Khandwala, MD, Principal investigator, Michigan Institute of Women's Health PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137539
- Sponsor's protocol ID
- MIWH08-001
- Acronym
- TVTSOffice
- Status last verified
- May 2017
- First submitted
- 24 May 2010
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVT-SECUR as an Office-based Procedure - A Pilot Study
- ClinicalTrials.gov ID
- NCT01137539
- Acronym / sponsor ID
- TVTSOffice / MIWH08-001
- Conditions
- Urinary Incontinence, Stress Urinary Incontinence
- Keywords
- urinary incontinence, stress urinary incontinence, mid-urethral slings, Tension-free vaginal taping, TVT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Michigan Institution of Women's Health PCUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 28 Jun 2017
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 pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.
This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
Detailed description
The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecare TVT-SECUR system | Experimental | Device: Gynecare TVT-SECUR systemAll patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stress urinary incontinence with hypermobility of the UV junction
- ASA I or II
- Age 21-89
Key exclusion criteria (5 listed)
- Prior anti-incontinence surgery
- Not completed childbearing
- ASA III or higher
- Need concomitant surgery
- Poor compliance for office based approach
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: TVT-S, Mid-urethral slingAll patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence | Device | Gynecare TVT-SECUR system |
Primary outcome
Treatment Success Based on Patient Report on Validated Questionnaire
Time frame: 24 months
Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.
1 secondary outcome
Patient Satisfaction
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Salil S Khandwala, MD principal investigator
Michigan Institute of Women's Health PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gynecare TVT-SECUR system in people with Urinary Incontinence and Stress Urinary Incontinence, run by Michigan Institution of Women's Health PC 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 3 inclusion and 5 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 28 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Success Based on Patient Report on Validated Questionnaire (time frame: 24 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 Jun 2017.