Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Spanner
|
Device: The Spanner Temporary Prostatic Stent
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days [90 days]
To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.
Secondary Outcome Measures
- Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days [30 days]
To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.
Other Outcome Measures
- The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days [30, 60 and 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".
- The Average Maximum Flow Rate Over 90 Days [1, 30, 60 and 90 days]
To determine the average and standard deviation of QMax at each stent visit (Visits 1-4)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 45 years;
-
In urinary retention and catheterized (indwelling or intermittent) for less than 180 days;
-
Documented diagnostic history (within 180 days of study) of detrusor contractility (>= 15 cmH2O) confirmed via pressure-flow test;
-
Negative Urinalysis on Visit 1;
-
Not a candidate for pharmacologic, minimally invasive or surgical treatment of the prostate;
-
Charlson Weighted Index of Comorbidity Score >= 1;
-
Willing and able to sign the Informed Consent Form;
-
Willing and able to complete the follow-up protocol requirements;
-
Experiencing catheter-induced discomfort.
Exclusion Criteria:
-
Current use of a urinary catheter daily for greater than 180 consecutive days immediately preceding entering into the study;
-
Positive Urinalysis on Visit 1;
-
Current or recent (within the last 6 months) urinary tract disease including urethral stricture, bladder stones, and other significant urological conditions or surgery;
-
Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affect the function of the lower urinary tract;
-
History of conditions associated with neurogenic bladder, including spinal cord injury, multiple sclerosis, or Parkinson's disease;
-
Use of anticholinergic medication;
-
Gross hematuria when catheter is removed on Visit 1;
-
Known or suspected prostate cancer;
-
Prior pelvic irradiation therapy;
-
Prostatic urethral length < 4 cm or > 9 cm (combined length from the top proximal side of the bladder neck to the bottom distal side of the external sphincter);
-
Intravesical enlargement of the median lobe of the prostate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlantic Urology | Daytona Beach | Florida | United States | 32114 |
| 2 | Advanced Urology Specialists | Oxford | Florida | United States | 34484 |
| 3 | Urology Specialists of West Florida | Palm Harbor | Florida | United States | 34684 |
| 4 | Pinellas Urology Inc | South Pasadena | Florida | United States | 33707 |
| 5 | Greater Boston Urology | Hingham | Massachusetts | United States | 02043 |
| 6 | Brooklyn Urology Research Group | Brooklyn | New York | United States | 11215 |
Sponsors and Collaborators
- SRS Medical
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- SRS 1.0
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Spanner |
|---|---|
| Arm/Group Description | The Spanner Temporary Prostatic Stent |
| Period Title: Overall Study | |
| STARTED | 107 |
| COMPLETED | 82 |
| NOT COMPLETED | 25 |
Baseline Characteristics
| Arm/Group Title | Spanner |
|---|---|
| Arm/Group Description | The Spanner Temporary Prostatic Stent |
| Overall Participants | 107 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
77.12
(10.62)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
107
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
104
97.2%
|
| Unknown or Not Reported |
3
2.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
107
100%
|
Outcome Measures
| Title | Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days |
|---|---|
| Description | To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml. |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat Population |
| Arm/Group Title | Spanner |
|---|---|
| Arm/Group Description | The Spanner Temporary Prostatic Stent |
| Measure Participants | 107 |
| Count of Participants [Participants] |
79
73.8%
|
| Title | Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days |
|---|---|
| Description | To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat Population |
| Arm/Group Title | Spanner |
|---|---|
| Arm/Group Description | The Spanner Temporary Prostatic Stent |
| Measure Participants | 107 |
| Count of Participants [Participants] |
86
80.4%
|
| Title | The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days |
|---|---|
| Description | 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". |
| Time Frame | 30, 60 and 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Spanner |
|---|---|
| Arm/Group Description | The Spanner Temporary Prostatic Stent |
| Measure Participants | 107 |
| Visit 2 (30 days) |
7.70
(6.84)
|
| Visit 3 (60 days) |
7.55
(6.24)
|
| Visit 4 (90 days) |
7.11
(6.1)
|
| Title | The Average Maximum Flow Rate Over 90 Days |
|---|---|
| Description | To determine the average and standard deviation of QMax at each stent visit (Visits 1-4) |
| Time Frame | 1, 30, 60 and 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All active patients in the Intent to Treat Population who voided prior to the PVR measurement during each visit. |
| Arm/Group Title | Spanner |
|---|---|
| Arm/Group Description | The Spanner Temporary Prostatic Stent |
| Measure Participants | 107 |
| Visit 1 (Day 1) |
11.91
(6.95)
|
| Visit 2 (30 days) |
11.37
(7.09)
|
| Visit 3 (60 days) |
11.77
(6.43)
|
| Visit 4 (90 days) |
9.55
(5.42)
|
Adverse Events
| Time Frame | AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Spanner | |
| Arm/Group Description | The Spanner Temporary Prostatic Stent | |
All Cause Mortality |
||
| Spanner | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/107 (0%) | |
Serious Adverse Events |
||
| Spanner | ||
| Affected / at Risk (%) | # Events | |
| Total | 15/107 (14%) | |
| Cardiac disorders | ||
| Atrial fibrillation | 2/107 (1.9%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/107 (0.9%) | |
| Gastrointestinal bleeding | 2/107 (1.9%) | |
| Malignant and unspecified neoplasms gastrointestinal | 1/107 (0.9%) | |
| General disorders | ||
| Weakness | 2/107 (1.9%) | |
| Flank discomfort and dysuria | 1/107 (0.9%) | |
| Hypotension and dehydration | 1/107 (0.9%) | |
| Shortness of breath and fever | 1/107 (0.9%) | |
| Fever, flu and mental state abnormal | 1/107 (0.9%) | |
| Fatigue and fever | 1/107 (0.9%) | |
| Infections and infestations | ||
| Clostridium difficile toxin test positive and E. coli urinary tract infection | 1/107 (0.9%) | |
| Urinary tract infection | 1/107 (0.9%) | |
| Musculoskeletal and connective tissue disorders | ||
| Intervertebral disc operation | 1/107 (0.9%) | |
| Skin and subcutaneous tissue disorders | ||
| Cellulitis | 1/107 (0.9%) | |
Other (Not Including Serious) Adverse Events |
||
| Spanner | ||
| Affected / at Risk (%) | # Events | |
| Total | 81/107 (75.7%) | |
| General disorders | ||
| Pain | 10/107 (9.3%) | |
| Renal and urinary disorders | ||
| Bacteriuria | 25/107 (23.4%) | |
| Urinary urgency | 8/107 (7.5%) | |
| Urinary frequency | 6/107 (5.6%) | |
| Dysuria | 6/107 (5.6%) | |
| Voiding difficulty | 6/107 (5.6%) | |
| Hematuria | 5/107 (4.7%) | |
| Urinary incontinence | 4/107 (3.7%) | |
| Urinary retention | 4/107 (3.7%) | |
| Urinary tract infection | 4/107 (3.7%) | |
| Penile pain | 3/107 (2.8%) | |
| Residual urine | 3/107 (2.8%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | SRS Medical |
| Phone | 800-345-5642 |
| info@srsmedical.com |
- SRS 1.0