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| Name | Class |
|---|---|
| Foundation for Female Health Awareness | OTHER |
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One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy and risk always compete for equilibrium. Level I evidence has demonstrated a positive efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without, pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination of surgical treatment of POP and SUI at the same time, however, increases the risk of incomplete bladder emptying. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. As the combination of POP and sling surgery increases the risk of voiding dysfunction, and rates of incomplete bladder emptying appear significantly lower for SIS than RP slings, the study team hypothesizes that the use of the Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP sling group | Experimental | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. |
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| SIS group | Experimental | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP sling placement | Device | A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Subjectively Bothersome Stress Incontinence | Dichotomous outcome (Yes/No), measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | 12 months post-operatively |
| Count of Participants Needing Retreatment for Stress Incontinence | This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery. | 12 months post-operatively |
| Count of Participants With De Novo or Worsening Urge Incontinence Symptoms | Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | 12 months post-operatively |
| Count of Participants Requiring Bladder Drainage | Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively.. | 12 Month post-operatively |
| Count of Participants Needing Surgical Intervention for Urinary Retention | Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively. | 12 Month post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system. | 12 months post-operatively |
| Surgeon Satisfaction Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Matthews, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health/National Center for Advance Pelvic Surgery | Washington D.C. | District of Columbia | 20010 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39689213 | Derived | Mezes CM, Russell GB, Gutman RE, Iglesia C, Rardin C, Kenton K, Collins S, Matthews CA. Effect of Vaginal Prolapse Repair and Midurethral Sling on Urgency Incontinence Symptoms. Urogynecology (Phila). 2025 Mar 1;31(3):250-257. doi: 10.1097/SPV.0000000000001620. Epub 2024 Dec 13. | |
| 38705225 | Derived | Matthews CA, Rardin CR, Sokol A, Iglesia C, Collins S, Ferrando C, Winkler H, Kenton K, Geynisman-Tan J, Gutman RE. A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair. Am J Obstet Gynecol. 2024 Aug;231(2):261.e1-261.e10. doi: 10.1016/j.ajog.2024.04.036. Epub 2024 May 3. |
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Total 280 patients signed the Informed Consent. Out of enrolled 280 patients, 3 withdrawn as screen failed, 21 dropped out before randomization, and 1 did not receive the treatment as per randomization. Hence enrolled number is larger than the randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | RP Sling Group | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2020 | Nov 20, 2024 |
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Participants and will be masked during the one-year follow-up period.Precautions will be taken to minimize unmasking the study groups: Since RP slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS group.
|
| SIS placement | Device | The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture. |
|
Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied.
| post-operatively up to 12 months |
| Northwestern Medical Group |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02903 | United States |
| 37888839 | 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. |
| FG001 | SIS Group | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RP Sling Group | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected. |
| BG001 | SIS Group | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants With Subjectively Bothersome Stress Incontinence | Dichotomous outcome (Yes/No), measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | Posted | Count of Participants | Participants | 12 months post-operatively |
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| Primary | Count of Participants Needing Retreatment for Stress Incontinence | This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery. | Posted | Count of Participants | Participants | 12 months post-operatively |
| ||||||||||||||||||||||||||||||||
| Primary | Count of Participants With De Novo or Worsening Urge Incontinence Symptoms | Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | Posted | Count of Participants | Participants | 12 months post-operatively |
| ||||||||||||||||||||||||||||||||
| Primary | Count of Participants Requiring Bladder Drainage | Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively.. | Posted | Count of Participants | Participants | 12 Month post-operatively |
| ||||||||||||||||||||||||||||||||
| Primary | Count of Participants Needing Surgical Intervention for Urinary Retention | Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively. | Posted | Number | participants | 12 Month post-operatively |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system. | Posted | Number | Participants with Adverse Events | 12 months post-operatively |
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| Secondary | Surgeon Satisfaction Scores | Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied. | Posted | Mean | Full Range | Score on a Scale | post-operatively up to 12 months |
|
1 year
Protocol defined urogynecologic adverse events collected.
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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 | RP Sling Group | Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected. | 0 | 129 | 7 | 129 | 40 | 129 |
| EG001 | SIS Group | Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture. | 0 | 126 | 6 | 126 | 47 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Voiding Dysfunction | Surgical and medical procedures | Non-systematic Assessment | Voiding Dysfunction led to sling lysis |
| |
| Urosepsis | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Pelvic Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Pelvic Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Recurrent Prolapse | Congenital, familial and genetic disorders | Non-systematic Assessment |
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| Pelvic Pain | Surgical and medical procedures | Non-systematic Assessment |
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| Death | Surgical and medical procedures | Non-systematic Assessment |
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| Urinary Retention | Surgical and medical procedures | Non-systematic Assessment | Urinary Retention leading to Sling Lysis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Surgical and medical procedures | Non-systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment | Vaginal // Pelvic Abscess |
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| Mesh Exposure | Surgical and medical procedures | Non-systematic Assessment |
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| Recurrent POP | Congenital, familial and genetic disorders | Non-systematic Assessment | POP = Pelvic Organ Prolapse |
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| Readmission for Complications | Surgical and medical procedures | Non-systematic Assessment |
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| Outpatient Surgical Intervention | Surgical and medical procedures | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Urgency "De Novo" | Renal and urinary disorders | Non-systematic Assessment |
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| Voiding Dysfunction | Renal and urinary disorders | Non-systematic Assessment |
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| Leg Pain | Surgical and medical procedures | Non-systematic Assessment |
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| Bowel Injury | Surgical and medical procedures | Non-systematic Assessment |
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| Bowel Obstruction | Surgical and medical procedures | Non-systematic Assessment |
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| Fistula | Surgical and medical procedures | Non-systematic Assessment |
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| Intestinal Injury | Surgical and medical procedures | Non-systematic Assessment |
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| Mesh Erosion | Surgical and medical procedures | Non-systematic Assessment |
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| Nerve Injury | Surgical and medical procedures | Non-systematic Assessment |
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| Venous Thromboembolism | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sachin Nalin Vyas, MS,PhD | Wake Forest University | 336-713-4098 | svyas@wakehealth.edu |
| Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2022 | Mar 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
| D011248 | Pregnancy Complications |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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