Stress Urinary IncontinencePhase 3SECURiTyNCT00534365
Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
A Phase 3 study testing tension-free vaginal tape and TVT-SECUR device in people with Stress Urinary Incontinence, run by The Cleveland Clinic at 7 sites in United States.
Trial summary
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence. 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?
- tension-free vaginal tape and TVT-SECUR device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2007to Apr 2011
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary incontinence symptoms
- Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- Age of at least 21 years
- Desires surgical correction of stress urinary incontinence
Who cannot join
- Post-void residual volume >100cc
- Detrusor overactivity on preoperative multichannel urodynamic testing
- History of previous synthetic, biologic or fascial sub-urethral sling
- Desires future childbearing
- History of bleeding diathesis or current anti-coagulation therapy
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Good Samaritan Hospital
Cincinnati, Ohio, 45520
Cleveland Clinic
Cleveland, Ohio, 44145
Duke University Medical Center
Durham, North Carolina, 27706
Main Line Health
Paoli, Pennsylvania, 19301
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- tension-free vaginal tape, TVT-SECUR device
- Keywords
- stress urinary incontinence, sling procedures, tension-free vaginal tape
- 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.
tension-free vaginal tapeDevice
Also called TVT
Retropubic mid-urethral sling
TVT-SECUR deviceDevice
Mid-urethral mini-sling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Tension-free vaginal tape procedure (TVT) Receives: Device: tension-free vaginal tape |
| 2 | Active comparator | TVT-SECUR device Receives: Device: TVT-SECUR device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Measured: 12 months
Secondary outcomes (4)
Post Operative Complications at 6 Week or Less
Measured: 6 week
Long Term Complications > 6 Weeks
Measured: 6 weeks-12 months
Patient Global Impression Improvement
Measured: 12 months
Incontinence Severity Index Score
The incontinence severity index comprises the following two questions. How often do you experience urine leakage (0=never, 1=less than once a month, 2=one or several times a month, 3=one or several times a week, 4=every day and/or night)? How much urine do you lose each time (1=drops or little, 2=more)? The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe).
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 posted24 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2011
- Study completionApr 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, Medstar Health Research Institute, Duke University, Foundation for Female Health Awareness, Women and Infants Hospital of Rhode Island, Main Line Health
- Responsible party
- Sponsor
- Investigators
- Matthew D Barber, MD, MHS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534365
- Sponsor's protocol ID
- FFHA 07-01
- Acronym
- SECURiTy
- Status last verified
- May 2017
- First submitted
- 20 Sep 2007
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, Ellerkmann M, Rardin CR, Iglesia CB, Toglia M; Foundation for Female Health Awareness Research Network. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):328-37. doi: 10.1097/AOG.0b013e318242a849.
PubMed 22270285Carter 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 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00534365
- Acronym / sponsor ID
- SECURiTy / FFHA 07-01
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, sling procedures, tension-free vaginal tape
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, Medstar Health Research Institute, Duke University, Foundation for Female Health Awareness, Women and Infants Hospital of Rhode Island, Main Line Health
- Study start
- Aug 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Posted 9 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: tension-free vaginal tapeTension-free vaginal tape procedure (TVT) |
| 2 | Active comparator | Device: TVT-SECUR deviceTVT-SECUR device |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Urinary incontinence symptoms
- Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- Age of at least 21 years
- Desires surgical correction of stress urinary incontinence
Key exclusion criteria (8 listed)
- Post-void residual volume >100cc
- Detrusor overactivity on preoperative multichannel urodynamic testing
- History of previous synthetic, biologic or fascial sub-urethral sling
- Desires future childbearing
- History of bleeding diathesis or current anti-coagulation therapy
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 |
|---|---|---|
| tension-free vaginal tapeAlso: TVTRetropubic mid-urethral sling | Device | 1 |
| TVT-SECUR deviceMid-urethral mini-sling | Device | 2 |
Primary outcome
Subjective Cure of Urinary Incontinence at 12 Months After Surgery
Time frame: 12 months
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
4 secondary outcomes
Post Operative Complications at 6 Week or Less
Time frame: 6 week
Long Term Complications > 6 Weeks
Time frame: 6 weeks-12 months
Patient Global Impression Improvement
Time frame: 12 months
Incontinence Severity Index Score
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 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22270285Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, Ellerkmann M, Rardin CR, Iglesia CB, Toglia M; Foundation for Female Health Awareness Research Network. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):328-37. doi: 10.1097/AOG.0b013e318242a849.
- 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.
- Foundation for Female Health AwarenessLink provided by the sponsor.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
Matthew D Barber, MD, MHS principal investigator
The Cleveland Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tension-free vaginal tape and TVT-SECUR device in people with Stress Urinary Incontinence, run by The Cleveland Clinic at 7 sites 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 4 inclusion and 8 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 9 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 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 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?
Subjective Cure of Urinary Incontinence at 12 Months After Surgery (time frame: 12 months). 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 NCT00534365, which also lists 2 linked publications.
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 9 Jun 2017.