Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities
Purpose. This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. Materials and Methods....
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| Format: | Article |
| Language: | English |
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Wiley
2022-01-01
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| Series: | Advances in Urology |
| Online Access: | http://dx.doi.org/10.1155/2022/7367851 |
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| author | Angelo J. Cambio Richard M. Roach Paul Arnold Joseph Cambio Clifford D. Gluck Sean P. Heron |
| author_facet | Angelo J. Cambio Richard M. Roach Paul Arnold Joseph Cambio Clifford D. Gluck Sean P. Heron |
| author_sort | Angelo J. Cambio |
| collection | DOAJ |
| description | Purpose. This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. Materials and Methods. The Spanner was placed for 3 cycles of 30 days in catheter-dependent men with comorbid conditions, confirmed detrusor contractility, and catheter-associated discomfort. At each visit, postvoid residual, maximum flow rate, international prostate symptom score, quality of life, and adverse events were assessed. Voiding success was defined as PVR ≤ 150 ml at all visits. Results. One hundred seven men were enrolled at 8 US sites; 82/107 (76.6%) completed the trial, and 79/107 (73.8%) successfully maintained PVR ≤ 150 ml for the trial duration. Patients were 77.1 ± 10.6 years old; 63/107 (58.9%) were dependent on Foley and 40/107 (37.4%) on intermittent catheterization for 36.0 ± 39.3 days and 30.2 ± 45.8 days, respectively. 25/107 (23.4%) discontinuations were primarily due to voluntary patient withdrawal 9/107 (8.4%), investigator-initiated withdrawal 8/107 (7.5%), or lack of effectiveness 4/107 (3.7%). During Spanner use, the mean Qmax was 11.2 ± 6.6, mean IPSS was 7.5 ± 6.4, and mean QOL was 2.0 ± 1.6. The most prevalent device-related adverse events were asymptomatic bacteriuria 25/107 (23.4%), discomfort 10/107 (9.4%), and urinary urgency 8/107 (7.5%). No device-related serious AEs were reported. Conclusions. This study demonstrates that catheter-dependent men with sufficient bladder contractility can achieve volitional voiding and successful bladder drainage using The Spanner Temporary Prostatic Stent for extended periods of time. |
| format | Article |
| id | doaj-art-f5e80335254a44f8b3f4c5e5d150645d |
| institution | Kabale University |
| issn | 1687-6377 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Advances in Urology |
| spelling | doaj-art-f5e80335254a44f8b3f4c5e5d150645d2025-02-03T06:05:32ZengWileyAdvances in Urology1687-63772022-01-01202210.1155/2022/7367851Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with ComorbiditiesAngelo J. Cambio0Richard M. Roach1Paul Arnold2Joseph Cambio3Clifford D. Gluck4Sean P. Heron5Brown Urology Brown PhysiciansAdvanced Urology InstituteAdvanced Urology InstituteBrown Urology Brown PhysiciansCarney HospitalPinellas UrologyPurpose. This US FDA investigational device exemption (IDE) study evaluated the extended use of The Spanner® Temporary Prostatic Stent in catheter-dependent men with urinary retention who were not deemed candidates for corrective surgery but demonstrated bladder contractility. Materials and Methods. The Spanner was placed for 3 cycles of 30 days in catheter-dependent men with comorbid conditions, confirmed detrusor contractility, and catheter-associated discomfort. At each visit, postvoid residual, maximum flow rate, international prostate symptom score, quality of life, and adverse events were assessed. Voiding success was defined as PVR ≤ 150 ml at all visits. Results. One hundred seven men were enrolled at 8 US sites; 82/107 (76.6%) completed the trial, and 79/107 (73.8%) successfully maintained PVR ≤ 150 ml for the trial duration. Patients were 77.1 ± 10.6 years old; 63/107 (58.9%) were dependent on Foley and 40/107 (37.4%) on intermittent catheterization for 36.0 ± 39.3 days and 30.2 ± 45.8 days, respectively. 25/107 (23.4%) discontinuations were primarily due to voluntary patient withdrawal 9/107 (8.4%), investigator-initiated withdrawal 8/107 (7.5%), or lack of effectiveness 4/107 (3.7%). During Spanner use, the mean Qmax was 11.2 ± 6.6, mean IPSS was 7.5 ± 6.4, and mean QOL was 2.0 ± 1.6. The most prevalent device-related adverse events were asymptomatic bacteriuria 25/107 (23.4%), discomfort 10/107 (9.4%), and urinary urgency 8/107 (7.5%). No device-related serious AEs were reported. Conclusions. This study demonstrates that catheter-dependent men with sufficient bladder contractility can achieve volitional voiding and successful bladder drainage using The Spanner Temporary Prostatic Stent for extended periods of time.http://dx.doi.org/10.1155/2022/7367851 |
| spellingShingle | Angelo J. Cambio Richard M. Roach Paul Arnold Joseph Cambio Clifford D. Gluck Sean P. Heron Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities Advances in Urology |
| title | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
| title_full | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
| title_fullStr | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
| title_full_unstemmed | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
| title_short | Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities |
| title_sort | extended use of the spanner r temporary prostatic stent in catheter dependent men with comorbidities |
| url | http://dx.doi.org/10.1155/2022/7367851 |
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