Trial Outcomes & Findings for Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men (NCT NCT02643849)

NCT ID: NCT02643849

Last Updated: 2020-11-19

Results Overview

To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 107 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2020-11-19

Participant Flow

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.

Participant milestones

Measure	Spanner The Spanner Temporary Prostatic Stent
Overall Study STARTED	107
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men

Baseline characteristics by cohort

Measure	Spanner n=107 Participants The Spanner Temporary Prostatic Stent
Age, Continuous	77.12 years STANDARD_DEVIATION 10.62 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Intent to Treat Population

To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.

Outcome measures

Measure	Spanner n=107 Participants The Spanner Temporary Prostatic Stent
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days	79 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent to Treat Population

To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.

Outcome measures

Measure	Spanner n=107 Participants The Spanner Temporary Prostatic Stent
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days	86 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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".

Outcome measures

Measure	Spanner n=107 Participants The Spanner Temporary Prostatic Stent
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
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
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

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

To determine the average and standard deviation of QMax at each stent visit (Visits 1-4)

Outcome measures

Measure	Spanner n=107 Participants The Spanner Temporary Prostatic Stent
The Average Maximum Flow Rate Over 90 Days Visit 1 (Day 1)	11.91 ml/s Standard Deviation 6.95
The Average Maximum Flow Rate Over 90 Days Visit 2 (30 days)	11.37 ml/s Standard Deviation 7.09
The Average Maximum Flow Rate Over 90 Days Visit 3 (60 days)	11.77 ml/s Standard Deviation 6.43
The Average Maximum Flow Rate Over 90 Days Visit 4 (90 days)	9.55 ml/s Standard Deviation 5.42

Adverse Events

Spanner

Serious events: 15 serious events

Other events: 81 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spanner n=107 participants at risk The Spanner Temporary Prostatic Stent
Gastrointestinal disorders Abdominal pain	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Weakness	1.9% 2/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Infections and infestations Clostridium difficile toxin test positive and E. coli urinary tract infection	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Gastrointestinal disorders Gastrointestinal bleeding	1.9% 2/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Flank discomfort and dysuria	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Cardiac disorders Atrial fibrillation	1.9% 2/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Musculoskeletal and connective tissue disorders Intervertebral disc operation	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Gastrointestinal disorders Malignant and unspecified neoplasms gastrointestinal	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Hypotension and dehydration	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Shortness of breath and fever	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Skin and subcutaneous tissue disorders Cellulitis	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Fever, flu and mental state abnormal	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Infections and infestations Urinary tract infection	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Fatigue and fever	0.93% 1/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.

Other adverse events

Measure	Spanner n=107 participants at risk The Spanner Temporary Prostatic Stent
Renal and urinary disorders Bacteriuria	23.4% 25/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
General disorders Pain	9.3% 10/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Urinary urgency	7.5% 8/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Urinary frequency	5.6% 6/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Dysuria	5.6% 6/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Voiding difficulty	5.6% 6/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Hematuria	4.7% 5/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Urinary incontinence	3.7% 4/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Urinary retention	3.7% 4/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Urinary tract infection	3.7% 4/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Penile pain	2.8% 3/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.
Renal and urinary disorders Residual urine	2.8% 3/107 • AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.

Additional Information

Director of Clinical Trials

SRS Medical

Phone: 800-345-5642

Email: info@srsmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place