REZUM
Report
- Report Number
- 2124215-2023-43169
- Event Type
- Injury
- Date Received
- August 14, 2023
- Date of Event
- August 1, 2023
- Report Date
- April 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH A WATER VAPOR THERAPY PROCEDURE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.
BABAR, M., LOLOI, J., TANG, K., SINGH, S., INES, M., PATEL, R. D., IQBAL, N., & CIATTO, M. (2023). REZUM WATER VAPOR THERAPY FOR PATIENTS WITH MILD, MODERATE, OR SEVERE LOWER URINARY TRACT SYMPTOMS: A RETROSPECTIVE STUDY IN A MULTIETHNIC POPULATION. THE PROSTATE, 83(7), 713-721. HTTPS://DOI.ORG/10.1002/PROS.24508. CORRECTION TO FIELD H6: PATIENT CODES. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS AND THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION DURING TREATMENT. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH A WATER VAPOR THERAPY PROCEDURE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE PROSTATE THAT A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS FROM A MULTIETHNIC POPULATION TREATED WITH REZUM BETWEEN 2017 AND 2019, TO EVALUATE THE SAFETY AND EFFICACY OF REZUM IN PATIENTS, WHO WERE CATEGORIZED INTO THREE COHORTS BASED ON BASELINE INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) LUTS SEVERITY: MILD LUTS, MODERATE LUTS AND SEVERE LUTS. A TOTAL OF 238 PATIENTS WERE INCLUDED: 33 WITH MILD LUTS, 109 WITH MODERATE LUTS AND 96 WITH SEVERE LUTS. OUTCOME MEASURES, INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), QUALITY OF LIFE (QOL), MAXIMUM URINARY FLOW RATE (QMAX), POSTVOID RESIDUAL (PVR), BPH MEDICATION USAGE, AND ADVERSE EVENTS (AES) WERE COLLECTED AND ANALYZED AT BASELINE, 1-, 3-, 6-, AND/OR 12-MONTHS POSTOPERATIVELY. AT 1-MONTH FOLLOW-UP, THE MODERATE AND SEVERE LUTS COHORTS SAW SIGNIFICANT IMPROVEMENTS IN IPSS (MODERATE LUTS: -3.0 [-6.0, 1.5], P < 0.001; SEVERE LUTS: -10.0 [-16.0, -5.0], P < 0.001) AND QOL (MODERATE LUTS: -1.0 [-3.0, 0.0], P < 0.001; SEVERE LUTS: -1.0 [-3.0, 0.0], P < 0.001) AND IMPROVEMENTS REMAINED DURABLE UP TO 12-MONTHS (P < 0.001). THE MILD LUTS COHORT SAW SIGNIFICANT WORSENING IN IPSS BY 2.0 (0.0, 12.0) AT 1-MONTH (P = 0.002) BUT RETURNED TO BASELINE AT 3-MONTHS (P = 0.114). HOWEVER, THE MILD LUTS COHORT EXPERIENCED SIGNIFICANT IMPROVEMENTS IN QOL BY -0.5 (-3.0, 0.0) AT 3-MONTHS (P = 0.035) AND NOCTURIA BY 0.0 (-1.0, 0.0) AT 6-MONTHS (P = 0.002), BOTH OF WHICH REMAINED DURABLE TO 12-MONTHS (P < 0.05). MOST AES WERE TRANSIENT AND NONSERIOUS, WITH GROSS HEMATURIA (66.5%) BEING MOST COMMON. THERE WERE NO SIGNIFICANT DIFFERENCES IN QOL POINT REDUCTION, QMAX IMPROVEMENT, PVR REDUCTION, AND AE OCCURRENCE BETWEEN THE COHORTS AT 12-MONTHS (P > 0.05). AT 12-MONTHS, 80.0%, 87.5%, AND 66.0% OF THE PATIENTS IN THE MILD, MODERATE, AND SEVERE LUTS COHORTS DISCONTINUED THEIR BPH MEDICATIONS, RESPECTIVELY.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE PROSTATE THAT A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS FROM A MULTIETHNIC POPULATION TREATED WITH REZUM BETWEEN 2017 AND 2019, TO EVALUATE THE SAFETY AND EFFICACY OF REZUM IN PATIENTS, WHO WERE CATEGORIZED INTO THREE COHORTS BASED ON BASELINE INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) LUTS SEVERITY: MILD LUTS, MODERATE LUTS AND SEVERE LUTS. A TOTAL OF 238 PATIENTS WERE INCLUDED: 33 WITH MILD LUTS, 109 WITH MODERATE LUTS AND 96 WITH SEVERE LUTS. OUTCOME MEASURES, INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), QUALITY OF LIFE (QOL), MAXIMUM URINARY FLOW RATE (QMAX), POSTVOID RESIDUAL (PVR), BPH MEDICATION USAGE, AND ADVERSE EVENTS (AES) WERE COLLECTED AND ANALYZED AT BASELINE, 1-, 3-, 6-, AND/OR 12-MONTHS POSTOPERATIVELY. AT 1-MONTH FOLLOW-UP, THE MODERATE AND SEVERE LUTS COHORTS SAW SIGNIFICANT IMPROVEMENTS IN IPSS (MODERATE LUTS: -3.0 [-6.0, 1.5], P < 0.001; SEVERE LUTS: -10.0 [-16.0, -5.0], P < 0.001) AND QOL (MODERATE LUTS: -1.0 [-3.0, 0.0], P < 0.001; SEVERE LUTS: -1.0 [-3.0, 0.0], P < 0.001) AND IMPROVEMENTS REMAINED DURABLE UP TO 12-MONTHS (P < 0.001). THE MILD LUTS COHORT SAW SIGNIFICANT WORSENING IN IPSS BY 2.0 (0.0, 12.0) AT 1-MONTH (P = 0.002) BUT RETURNED TO BASELINE AT 3-MONTHS (P = 0.114). HOWEVER, THE MILD LUTS COHORT EXPERIENCED SIGNIFICANT IMPROVEMENTS IN QOL BY -0.5 (-3.0, 0.0) AT 3-MONTHS (P = 0.035) AND NOCTURIA BY 0.0 (-1.0, 0.0) AT 6-MONTHS (P = 0.002), BOTH OF WHICH REMAINED DURABLE TO 12-MONTHS (P < 0.05). MOST AES WERE TRANSIENT AND NONSERIOUS, WITH GROSS HEMATURIA (66.5%) BEING MOST COMMON. THERE WERE NO SIGNIFICANT DIFFERENCES IN QOL POINT REDUCTION, QMAX IMPROVEMENT, PVR REDUCTION, AND AE OCCURRENCE BETWEEN THE COHORTS AT 12-MONTHS (P > 0.05). AT 12-MONTHS, 80.0%, 87.5%, AND 66.0% OF THE PATIENTS IN THE MILD, MODERATE, AND SEVERE LUTS COHORTS DISCONTINUED THEIR BPH MEDICATIONS, RESPECTIVELY.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE PROSTATE THAT A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS FROM A MULTIETHNIC POPULATION TREATED WITH REZUM BETWEEN 2017 AND 2019, TO EVALUATE THE SAFETY AND EFFICACY OF REZUM IN PATIENTS, WHO WERE CATEGORIZED INTO THREE COHORTS BASED ON BASELINE INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS) LUTS SEVERITY: MILD LUTS, MODERATE LUTS AND SEVERE LUTS. A TOTAL OF 238 PATIENTS WERE INCLUDED: 33 WITH MILD LUTS, 109 WITH MODERATE LUTS AND 96 WITH SEVERE LUTS. OUTCOME MEASURES, INCLUDING INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), QUALITY OF LIFE (QOL), MAXIMUM URINARY FLOW RATE (QMAX), POSTVOID RESIDUAL (PVR), BPH MEDICATION USAGE, AND ADVERSE EVENTS (AES) WERE COLLECTED AND ANALYZED AT BASELINE, 1-, 3-, 6-, AND/OR 12-MONTHS POSTOPERATIVELY. AT 1-MONTH FOLLOW-UP, THE MODERATE AND SEVERE LUTS COHORTS SAW SIGNIFICANT IMPROVEMENTS IN IPSS (MODERATE LUTS: -3.0 [-6.0, 1.5], P < 0.001; SEVERE LUTS: -10.0 [-16.0, -5.0], P < 0.001) AND QOL (MODERATE LUTS: -1.0 [-3.0, 0.0], P < 0.001; SEVERE LUTS: -1.0 [-3.0, 0.0], P < 0.001) AND IMPROVEMENTS REMAINED DURABLE UP TO 12-MONTHS (P < 0.001). THE MILD LUTS COHORT SAW SIGNIFICANT WORSENING IN IPSS BY 2.0 (0.0, 12.0) AT 1-MONTH (P = 0.002) BUT RETURNED TO BASELINE AT 3-MONTHS (P = 0.114). HOWEVER, THE MILD LUTS COHORT EXPERIENCED SIGNIFICANT IMPROVEMENTS IN QOL BY -0.5 (-3.0, 0.0) AT 3-MONTHS (P = 0.035) AND NOCTURIA BY 0.0 (-1.0, 0.0) AT 6-MONTHS (P = 0.002), BOTH OF WHICH REMAINED DURABLE TO 12-MONTHS (P < 0.05). MOST AES WERE TRANSIENT AND NONSERIOUS, WITH GROSS HEMATURIA (66.5%) BEING MOST COMMON. THERE WERE NO SIGNIFICANT DIFFERENCES IN QOL POINT REDUCTION, QMAX IMPROVEMENT, PVR REDUCTION, AND AE OCCURRENCE BETWEEN THE COHORTS AT 12-MONTHS (P > 0.05). AT 12-MONTHS, 80.0%, 87.5%, AND 66.0% OF THE PATIENTS IN THE MILD, MODERATE, AND SEVERE LUTS COHORTS DISCONTINUED THEIR BPH MEDICATIONS, RESPECTIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307446 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H| O |