Stress Urinary IncontinencePhase 4NCT00676273
TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
A Phase 4 study testing TVT-Obturator (TVT-O) and TVT-Secur (TVT-S) (Hammock method) in people with Stress Urinary Incontinence, run by Boston Urogynecology Associates at 1 site in United States.
Trial summary
The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TVT-Obturator (TVT-O) and TVT-Secur (TVT-S) (Hammock method)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2009
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age
- Demonstrate a positive cough stress test during complex multi-channel urodynamic testing
- Demonstrate impact of stress urinary incontinence on quality of life questionnaire
- Are able to comprehend and sign a written informed consent
- Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations
- Are psychologically stable and suitable for interventions determined by the investigator
- Are ambulatory and able to use a toilet independently
Who cannot join
- Patients:
- Who are pregnant or planning to become pregnant during the study or in the future
- With a elevated post-void residual (defined as PVR > 100cc)
- With a bleeding condition or on anti-coagulant therapy
- With immunosuppression (i.e. HIV, lymphoma)
- With multiple sclerosis or other progressive neurological disease
Show all 10Show fewer
- With evidence of a local or systemic infection, including urinary tract infection
- With evidence of intrinsic sphincter deficiency as defined by a maximal urethral closure pressure of <20 cm H2O
- Previous sub-urethral sling
- Predominant overactive bladder symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138
Lekha Hota, MD, 617-354-5452
Peter Rosenblatt, MD
About this study
The purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.
Read the detailed description
Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.
- Conditions
- Stress Urinary Incontinence
- Being tested
- TVT-Obturator (TVT-O), TVT-Secur (TVT-S) (Hammock method)
- 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.
TVT-Obturator (TVT-O)Device
sub urethral sling
TVT-Secur (TVT-S) (Hammock method)Device
suburethral sling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | TVTO Receives: Device: TVT-Obturator (TVT-O) |
| 2 | Active comparator | TVTS Receives: Device: TVT-Secur (TVT-S) (Hammock method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test.
Measured: 1 year
Secondary outcomes (1)
To describe or assess known side effects or complications,post-operative pain, time of return to daily activities of living, improvement in patient quality of life, change in Q-tip test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Urogynecology Associates
- Sponsor type
- University, hospital or other
- Investigators
- Peter Rosenblatt, MD, Principal investigator, Boston Urogynecology AssociatesLekha Hota, MD, Study director, Boston Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676273
- Sponsor's protocol ID
- 28142
- Status last verified
- May 2008
- First submitted
- 16 Nov 2007
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures
- ClinicalTrials.gov ID
- NCT00676273
- Acronym / sponsor ID
- 28142
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Boston Urogynecology AssociatesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 May 2008 (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 purpose of this study is to determine whether TVT-Secur (TVT-S) (Hammock method) and TVT-Obturator (TVT-O) suburethral sling procedures have equivalent patient satisfaction and clinical efficacy in the treatment of stress urinary incontinence alone or the stress component in mixed urinary incontinence.
Detailed description
Patient satisfaction will be measured by symptom quality of life questionnaires (pre-operatively, 3 months and one year) and patient pain will be measured by verbal analogue rating scale (post-operative day 1 and day 7). Clinical efficacy will be measured by a cough stress test pre-operatively and post-operatively at 3 months and 1 year. A Q-tip test will also be performed pre-operatively and at 3 months and 1 year post-operatively. Subjects will be followed for a minimum of one year to evaluate recurrence of symptoms and complications, including the rate of mesh erosion, time to normal void in the post-operative period, the rate of sling revision, post-operative pain, voiding dysfunction and de novo urgency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: TVT-Obturator (TVT-O)TVTO |
| 2 | Active comparator | Device: TVT-Secur (TVT-S) (Hammock method)TVTS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 18 years of age
- Demonstrate a positive cough stress test during complex multi-channel urodynamic testing
- Demonstrate impact of stress urinary incontinence on quality of life questionnaire
- Are able to comprehend and sign a written informed consent
- Understand and are willing to comply with the study requirements, including agreeing to be available for the follow-up evaluations
Key exclusion criteria (10 listed)
- Who are pregnant or planning to become pregnant during the study or in the future
- With a elevated post-void residual (defined as PVR > 100cc)
- With a bleeding condition or on anti-coagulant therapy
- With immunosuppression (i.e. HIV, lymphoma)
- With multiple sclerosis or other progressive neurological disease
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 |
|---|---|---|
| TVT-Obturator (TVT-O)sub urethral sling | Device | 1 |
| TVT-Secur (TVT-S) (Hammock method)suburethral sling | Device | 2 |
Primary outcome
To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test.
Time frame: 1 year
1 secondary outcome
To describe or assess known side effects or complications,post-operative pain, time of return to daily activities of living, improvement in patient quality of life, change in Q-tip test
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
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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.
Peter Rosenblatt, MD principal investigator
Boston Urogynecology Associates
Lekha Hota, MD study director
Boston Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TVT-Obturator (TVT-O) and TVT-Secur (TVT-S) (Hammock method) in people with Stress Urinary Incontinence, run by Boston Urogynecology Associates 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 May 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of TVT-S versus TVT-O suburethral slings in the treatment of stress urinary incontinence or the stress incontinence component of mixed urinary incontinence by the presence or absence or urinary incontinence on cough stress test. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676273, which also lists 1 linked publication.
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 13 May 2008.