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The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spanner | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Spanner Temporary Prostatic Stent | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days | To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days | To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days | To determine the distribution of IPSS Scores at each stent replacement visit (Visit 2, 3 and 4). The IPSS Score is calculated from the responses to seven questions related to the severity and frequency of symptoms of benign prostatic hyperplasia (BPH). Each of the seven scored questions are put on a scale of 0-5, with the score of 5 being the worst score and the most severe symptom. The scores for the seven questions are added up and the IPSS score therefore ranges from 0-35, with 0 being the best score and 35 being the worst score. Scores of 0-7 are categorized as "Mild Symptoms". Scores of 8-19 are categorized as "Moderate Symptoms". Scores of 20-35 are categorized as "Severe Symptoms". |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Urology | Daytona Beach | Florida | 32114 | United States | ||
| Advanced Urology Specialists |
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A total of 109 subjects were screened for inclusion. Two subjects were excluded because they did not meet all inclusion/exclusion criteria and did not participate. Therefore the Intent to Treat population was 107 subjects, each of whom received at least 1 stent insertion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spanner | The Spanner Temporary Prostatic Stent |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2019 | Oct 21, 2020 |
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| 30, 60 and 90 days |
| The Average Maximum Flow Rate Over 90 Days | To determine the average and standard deviation of QMax at each stent visit (Visits 1-4) | 1, 30, 60 and 90 days |
| Oxford |
| Florida |
| 34484 |
| United States |
| Urology Specialists of West Florida | Palm Harbor | Florida | 34684 | United States |
| Pinellas Urology Inc | South Pasadena | Florida | 33707 | United States |
| Greater Boston Urology | Hingham | Massachusetts | 02043 | United States |
| Brooklyn Urology Research Group | Brooklyn | New York | 11215 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
All study subjects were catheter dependent, with comorbid conditions and were on medications/treatment regiments for those conditions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spanner | The Spanner Temporary Prostatic Stent |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days | To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml. | Intent to Treat Population | Posted | Count of Participants | Participants | 90 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days | To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml. | Intent to Treat Population | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days | To determine the distribution of IPSS Scores at each stent replacement visit (Visit 2, 3 and 4). The IPSS Score is calculated from the responses to seven questions related to the severity and frequency of symptoms of benign prostatic hyperplasia (BPH). Each of the seven scored questions are put on a scale of 0-5, with the score of 5 being the worst score and the most severe symptom. The scores for the seven questions are added up and the IPSS score therefore ranges from 0-35, with 0 being the best score and 35 being the worst score. Scores of 0-7 are categorized as "Mild Symptoms". Scores of 8-19 are categorized as "Moderate Symptoms". Scores of 20-35 are categorized as "Severe Symptoms". | All active patients in the Intent to Treat Population. On Visit 2, 89 subjects remained active in the study. On Visit 3 and Visit 4 82 subjects remained active in the study. | Posted | Mean | Standard Deviation | score on a scale | 30, 60 and 90 days |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | The Average Maximum Flow Rate Over 90 Days | To determine the average and standard deviation of QMax at each stent visit (Visits 1-4) | All active patients in the Intent to Treat Population who voided prior to the PVR measurement during each visit. | Posted | Mean | Standard Deviation | ml/s | 1, 30, 60 and 90 days |
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AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
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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 | Spanner | The Spanner Temporary Prostatic Stent | 0 | 107 | 15 | 107 | 81 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA | Systematic Assessment |
| |
| Clostridium difficile toxin test positive and E. coli urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flank discomfort and dysuria | General disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc operation | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Malignant and unspecified neoplasms gastrointestinal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hypotension and dehydration | General disorders | MedDRA | Systematic Assessment |
| |
| Shortness of breath and fever | General disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Fever, flu and mental state abnormal | General disorders | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fatigue and fever | General disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteriuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Voiding difficulty | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Penile pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Residual urine | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | SRS Medical | 800-345-5642 | info@srsmedical.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 27, 2016 | Nov 13, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
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| Title | Denominators | Categories |
|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Visit 1 (Day 1) |
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| Visit 2 (30 days) |
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| Visit 3 (60 days) |
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| Visit 4 (90 days) |
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