REZUM
Report
- Report Number
- 2124215-2025-93995
- Event Type
- Injury
- Date Received
- December 31, 2025
- Date of Event
- October 30, 2021
- Report Date
- February 2, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS REVIEWED. THE PATIENT SYMPTOM OF SEXUAL DYSFUNCTION WAS FOUND TO BE LISTED IN THE IFU. THE PATIENT SYMPTOM IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE/PROCEDURE, AND IT IS NOTED AS SUCH IN THE INSTRUCTIONS FOR USE. CORRECTION TO FIELD A2: AGE AT TIME OF EVENT, UNIT OF MEASURE - AGE. B3. DATE OF EVENT: ACTUAL EVENT DATE IS UNKNOWN; ARTICLE PUBLISHED DATE HAS BEEN SELECTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MCVARY K. T., EL-ARABI A., AND ROEHRBORN, C. (2021). PRESERVATION OF SEXUAL FUNCTION 5 YEARS AFTER WATER VAPOR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA. SEXUAL MEDICINE, 9:100454. HTTPS://DOI.ORG/10.1016/J.ESXM.2021.100454.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MCVARY K. T., EL-ARABI A., AND ROEHRBORN, C. (2021). PRESERVATION OF SEXUAL FUNCTION 5 YEARS AFTER WATER VAPOR THERMAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA. SEXUAL MEDICINE, 9:100454. HTTPS://DOI.ORG/10.1016/J.ESXM.2021.100454.
IT WAS REPORTED VIA AN ARTICLE PUBLISHED ON SEXUAL MEDICINE THAT A STUDY WAS CONDUCTED TO EVALUATE LONG-TERM IMPACT OF A SINGLE WATER VAPOR THERMAL THERAPY (WVTT) PROCEDURE ON ERECTILE AND EJACULATORY FUNCTION IN SUBJECTS ENROLLED IN THE REZUM II PROSPECTIVE, MULTICENTER, RANDOMIZED, BLINDED CONTROLLED TRIAL. A TOTAL OF 197 PATIENTS ENROLLED (136 WERE TREATED AND 61 WERE UNDER CONTROL) IN 15 CENTERS. UNBLINDED AT THE 3-MONTH FOLLOW-UP VISIT, 53 PATIENTS FROM THE CONTROL GROUP DECIDED TO CROSS-OVER AND RECEIVED WVTT. AT THE END A TOTAL OF 125 SUBJECTS FROM THE TREATMENT AND CROSS-OVER GROUPS WERE INCLUDED IN THIS SUB ANALYSIS WITH 67 SUBJECTS REMAINING. RESULTS SUGGEST THAT TREATMENT OF LOWER URINARY TRACT SYMPTOMS (LUTS) /BENIGN PROSTATIC HYPERPLASIA (BPH) WITH WVTT DOES NOT HAVE A CLINICALLY MEANINGFUL IMPACT ON ERECTILE OR EJACULATORY FUNCTION SINCE PATIENTS STAY WITHIN THEIR SCORE CATEGORY. A NON-CLINICALLY SIGNIFICANT DECLINE IN SEXUAL FUNCTION WAS OBSERVED AMONG SUBJECTS IN THE BASELINE ED (ERECTILE DYSFUNCTION) AND EJD (EJACULATORY DYSFUNCTION) GROUPS COMPARED TO SUBJECTS REPORTING NO ED/EJD WHO SHOWED LITTLE CHANGE. IN SUBJECTS WITH PRE-EXISTING ED AND/OR EJD, LUTS IMPROVEMENT OCCURRED SIMILARLY BETWEEN THOSE WITH BASELINE ED AND EJD COMPARED TO THOSE WITHOUT BASELINE DYSFUNCTION. RESULTS SUGGEST THAT TREATMENT OF LUTS/BPH WITH WVTT DOES NOT HAVE A CLINICALLY MEANINGFUL IMPACT ON ERECTILE OR EJACULATORY FUNCTION SINCE PATIENTS STAY WITHIN THEIR SCORE CATEGORY. THE GRADUAL DECLINE IN SEXUAL FUNCTION OVER 5 YEARS SEEN IN THIS ANALYSIS POSSIBLY REFLECTS THE PARA-AGING PROCESS.
IT WAS REPORTED VIA AN ARTICLE PUBLISHED ON SEXUAL MEDICINE THAT A STUDY WAS CONDUCTED TO EVALUATE LONG-TERM IMPACT OF A SINGLE WATER VAPOR THERMAL THERAPY (WVTT) PROCEDURE ON ERECTILE AND EJACULATORY FUNCTION IN SUBJECTS ENROLLED IN THE REZUM II PROSPECTIVE, MULTICENTER, RANDOMIZED, BLINDED CONTROLLED TRIAL. A TOTAL OF 197 PATIENTS ENROLLED (136 WERE TREATED AND 61 WERE UNDER CONTROL) IN 15 CENTERS. UNBLINDED AT THE 3-MONTH FOLLOW-UP VISIT, 53 PATIENTS FROM THE CONTROL GROUP DECIDED TO CROSS-OVER AND RECEIVED WVTT. AT THE END A TOTAL OF 125 SUBJECTS FROM THE TREATMENT AND CROSS-OVER GROUPS WERE INCLUDED IN THIS SUB ANALYSIS WITH 67 SUBJECTS REMAINING. RESULTS SUGGEST THAT TREATMENT OF LOWER URINARY TRACT SYMPTOMS (LUTS) /BENIGN PROSTATIC HYPERPLASIA (BPH) WITH WVTT DOES NOT HAVE A CLINICALLY MEANINGFUL IMPACT ON ERECTILE OR EJACULATORY FUNCTION SINCE PATIENTS STAY WITHIN THEIR SCORE CATEGORY. A NON-CLINICALLY SIGNIFICANT DECLINE IN SEXUAL FUNCTION WAS OBSERVED AMONG SUBJECTS IN THE BASELINE ED (ERECTILE DYSFUNCTION) AND EJD (EJACULATORY DYSFUNCTION) GROUPS COMPARED TO SUBJECTS REPORTING NO ED/EJD WHO SHOWED LITTLE CHANGE. IN SUBJECTS WITH PRE-EXISTING ED AND/OR EJD, LUTS IMPROVEMENT OCCURRED SIMILARLY BETWEEN THOSE WITH BASELINE ED AND EJD COMPARED TO THOSE WITHOUT BASELINE DYSFUNCTION. RESULTS SUGGEST THAT TREATMENT OF LUTS/BPH WITH WVTT DOES NOT HAVE A CLINICALLY MEANINGFUL IMPACT ON ERECTILE OR EJACULATORY FUNCTION SINCE PATIENTS STAY WITHIN THEIR SCORE CATEGORY. THE GRADUAL DECLINE IN SEXUAL FUNCTION OVER 5 YEARS SEEN IN THIS ANALYSIS POSSIBLY REFLECTS THE PARA-AGING PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2638946 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Other |