Urinary Retention
Conditions
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.
Interventions
DEVICEThe Spanner Temporary Prostatic Stent
Sponsors
SRS Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Spanner The Spanner Temporary Prostatic Stent | 107 |
| Total | 107 |
Baseline characteristics
| Characteristic | Spanner |
|---|---|
| Age, Continuous | 77.12 years STANDARD_DEVIATION 10.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Region of Enrollment United States | 107 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 107 |
| other Total, other adverse events | 81 / 107 |
| serious Total, serious adverse events | 15 / 107 |
Outcome results
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.
Time frame: 90 days
Population: Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spanner | Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days | 79 Participants |
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.
Time frame: 30 days
Population: Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spanner | Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days | 86 Participants |
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)
Time frame: 1, 30, 60 and 90 days
Population: All active patients in the Intent to Treat Population who voided prior to the PVR measurement during each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spanner | The Average Maximum Flow Rate Over 90 Days | Visit 3 (60 days) | 11.77 ml/s | Standard Deviation 6.43 |
| Spanner | The Average Maximum Flow Rate Over 90 Days | Visit 4 (90 days) | 9.55 ml/s | Standard Deviation 5.42 |
| Spanner | The Average Maximum Flow Rate Over 90 Days | Visit 1 (Day 1) | 11.91 ml/s | Standard Deviation 6.95 |
| Spanner | The Average Maximum Flow Rate Over 90 Days | Visit 2 (30 days) | 11.37 ml/s | Standard Deviation 7.09 |
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.
Time frame: 30, 60 and 90 days
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spanner | The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days | Visit 2 (30 days) | 7.70 score on a scale | Standard Deviation 6.84 |
| Spanner | The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days | Visit 3 (60 days) | 7.55 score on a scale | Standard Deviation 6.24 |
| Spanner | The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days | Visit 4 (90 days) | 7.11 score on a scale | Standard Deviation 6.1 |