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| Name | Class |
|---|---|
| Good Samaritan Hospital, Ohio | OTHER |
| Greater Baltimore Medical Center | OTHER |
| Medstar Health Research Institute | OTHER |
| Duke University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Tension-free vaginal tape procedure (TVT) |
|
| 2 | Active Comparator | TVT-SECUR device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tension-free vaginal tape | Device | Retropubic mid-urethral sling |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Complications at 6 Week or Less | 6 week | |
| Long Term Complications > 6 Weeks | 6 weeks-12 months | |
| Patient Global Impression Improvement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew D Barber, MD, MHS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Greater Baltimore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22270285 | Result | 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. | |
| 37888839 |
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A total of 281 patients were enrolled. Of these, 18 patients withdrew prior to randomization (including for the following reasons- cancelled surgery (6), did not meet inclusion criteria (4), declined further participation (8)).
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| ID | Title | Description |
|---|---|---|
| FG000 | TVT Procedure | Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling |
| FG001 | TVT-SECUR Mini Sling Procedure | TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | TVT Procedure | Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling |
| BG001 | TVT-SECUR Mini Sling Procedure | TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis based on per protocol enrollment | Posted | Count of Participants | Participants | 12 months |
|
Intraoperative complications at time of surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TVT-SECUR Mini Sling Procedure | TVT-SECUR device TVT-SECUR device: Mid-urethral mini-sling |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Borzi (Research Administrator) | Cleveland Clinic | 216-445-3158 | BORZIL@ccf.org |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| OTHER |
| Foundation for Female Health Awareness | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
| Main Line Health | OTHER |
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| TVT-SECUR device | Device | Mid-urethral mini-sling |
|
| 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). | 12 months |
| Baltimore |
| Maryland |
| 21204 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27706 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45520 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44145 | United States |
| Main Line Health | Paoli | Pennsylvania | 19301 | United States |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02903 | United States |
| Derived |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Secondary | Post Operative Complications at 6 Week or Less | Posted | Number | participants | 6 week |
|
|
|
| Secondary | Long Term Complications > 6 Weeks | Posted | Number | participants | 6 weeks-12 months |
|
|
|
| Secondary | Patient Global Impression Improvement | Please note that no all participants conducted the global improvement scale survey due to loss to follow up. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 0 |
| 136 |
| 6 |
| 136 |
| EG001 | TVT Procedure | Tension-free vaginal tape procedure (TVT) tension-free vaginal tape: Retropubic mid-urethral sling | 0 | 127 | 8 | 127 |
| Blood transfusion | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Ureteral injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Bowel injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Cardiac or MI |
|
| Neurologic |
|
| Pulmonary |
|
| Ileus or small bowel obstruction |
|
| Pelvic abscess |
|
| Blood transfusion |
|
| Venous thromboembolism |
|
| Return to operating room |
|
| Hospital readmissions |
|
| Emergency room evaluations |
|
| Unplanned clinic visits |
|
| Neurologic |
|
| Pulmonary |
|
| Ileu or small bowel obstruction |
|
| Mesh exposure |
|
| Leg pain or difficulty ambulatig |
|
| Fistula |
|
| Somewhat better |
|
| No different |
|
| Somewhat worse |
|
| Much worse |
|
| Very much worse |
|