REZUM
Report
- Report Number
- 2124215-2026-00832
- Event Type
- Injury
- Date Received
- January 6, 2026
- Date of Event
- October 13, 2018
- Report Date
- February 3, 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
THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. 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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MCVARY KT, ROGERS T, MAHON J, ET AL. IS SEXUAL FUNCTION BETTER PRESERVED AFTER WATER VAPOR THERMAL THERAPY OR MEDICAL THERAPY FOR LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA? J SEX MED 2018;15(12):1728-38.
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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MCVARY KT, ROGERS T, MAHON J, ET AL. IS SEXUAL FUNCTION BETTER PRESERVED AFTER WATER VAPOR THERMAL THERAPY OR MEDICAL THERAPY FOR LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA? J SEX MED 2018;15(12):1728-38.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF SEXUAL MEDICINE THAT A STUDY WAS CONDUCTED TO COMPARE SEXUAL FUNCTION OVER 3 YEARS AFTER CONTINUOUS DAILY TREATMENT WITH PHARMACEUTICAL AGENTS IN THE MEDICAL THERAPY OF PROSTATIC SYMPTOMS (MTOPS) STUDY VS A SINGLE THERMAL THERAPY PROCEDURE (REZUM STUDY) IN SUBJECTS WITH MATCHED CRITERIA FOR LUTS SEVERITY AND PROSTATE SIZE. SEXUAL FUNCTION DATA FROM SEXUALLY ACTIVE COHORTS IN THE MTOPS STUDY (1,209) RANDOMIZED TO DOXAZOSIN, FINASTERIDE, COMBINATION DRUGS AND PLACEBO, AND SEXUALLY ACTIVE MEN WHO RECEIVED THERMAL THERAPY (86) WAS USED. A TOTAL OF 1477 SUBJECTS WERE INVOLVED. MTOPS STUDY PARTICIPANTS COMPLETED THE BRIEF MALE SEXUAL FUNCTION INVENTORY; MEN IN THE REZUM TRIAL COMPLETED THE INTERNATIONAL INDEX OF ERECTILE FUNCTION AND MALE SEXUAL HEALTH QUESTIONNAIRE. ESTIMATED MEAN CHANGES FROM BASELINE FOR SEXUAL FUNCTION VARIABLES WERE COMPARED USING A LINEAR MIXED REPEATED MEASURES MODEL WITH FIXED EFFECTS FOR TREATMENT AND FOLLOW-UP VISITS. WITH CONTINUED DAILY DRUG USE, MEN EXPERIENCED SIGNIFICANT WORSENING OF SEXUAL DESIRE, ERECTILE AND EJACULATORY FUNCTION WITH FINASTERIDE AND COMBINATION DRUG THERAPY, AND REDUCED DESIRE AND ERECTILE FUNCTION WITH DOXAZOSIN. THERMAL THERAPY WAS NOT ASSOCIATED WITH SIGNIFICANT NEGATIVE CHANGES IN SEXUAL FUNCTION THROUGHOUT 3 YEARS AFTER TREATMENT. SOME OF THE OUTCOMES EXPERIENCED BY THE PATIENTS WERE ERECTILE DYSFUNCTION, EJACULATORY DYSFUNCTION, WORSENING OF SEXUAL DESIRE AND OVERALL SEXUAL SATISFACTION DECREASE. A SINGLE WATER VAPOR THERMAL THERAPY PROCEDURE FOR TARGETED PROSTATE TISSUE ABLATION FOR LUTS/ BENIGN PROSTATIC HYPERPLASIA HAD NO DELETERIOUS EFFECT ON 4 SEXUAL FUNCTION DOMAINS COMPARED WITH APPRECIABLE WORSENING OF SEXUAL FUNCTION AFTER LONG-TERM SINGLE OR COMBINATION DRUG USE.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF SEXUAL MEDICINE THAT A STUDY WAS CONDUCTED TO COMPARE SEXUAL FUNCTION OVER 3 YEARS AFTER CONTINUOUS DAILY TREATMENT WITH PHARMACEUTICAL AGENTS IN THE MEDICAL THERAPY OF PROSTATIC SYMPTOMS (MTOPS) STUDY VS A SINGLE THERMAL THERAPY PROCEDURE (REZUM STUDY) IN SUBJECTS WITH MATCHED CRITERIA FOR LUTS SEVERITY AND PROSTATE SIZE. SEXUAL FUNCTION DATA FROM SEXUALLY ACTIVE COHORTS IN THE MTOPS STUDY (1,209) RANDOMIZED TO DOXAZOSIN, FINASTERIDE, COMBINATION DRUGS AND PLACEBO, AND SEXUALLY ACTIVE MEN WHO RECEIVED THERMAL THERAPY (86) WAS USED. A TOTAL OF 1477 SUBJECTS WERE INVOLVED. MTOPS STUDY PARTICIPANTS COMPLETED THE BRIEF MALE SEXUAL FUNCTION INVENTORY; MEN IN THE REZUM TRIAL COMPLETED THE INTERNATIONAL INDEX OF ERECTILE FUNCTION AND MALE SEXUAL HEALTH QUESTIONNAIRE. ESTIMATED MEAN CHANGES FROM BASELINE FOR SEXUAL FUNCTION VARIABLES WERE COMPARED USING A LINEAR MIXED REPEATED MEASURES MODEL WITH FIXED EFFECTS FOR TREATMENT AND FOLLOW-UP VISITS. WITH CONTINUED DAILY DRUG USE, MEN EXPERIENCED SIGNIFICANT WORSENING OF SEXUAL DESIRE, ERECTILE AND EJACULATORY FUNCTION WITH FINASTERIDE AND COMBINATION DRUG THERAPY, AND REDUCED DESIRE AND ERECTILE FUNCTION WITH DOXAZOSIN. THERMAL THERAPY WAS NOT ASSOCIATED WITH SIGNIFICANT NEGATIVE CHANGES IN SEXUAL FUNCTION THROUGHOUT 3 YEARS AFTER TREATMENT. SOME OF THE OUTCOMES EXPERIENCED BY THE PATIENTS WERE ERECTILE DYSFUNCTION, EJACULATORY DYSFUNCTION, WORSENING OF SEXUAL DESIRE AND OVERALL SEXUAL SATISFACTION DECREASE. A SINGLE WATER VAPOR THERMAL THERAPY PROCEDURE FOR TARGETED PROSTATE TISSUE ABLATION FOR LUTS/ BENIGN PROSTATIC HYPERPLASIA HAD NO DELETERIOUS EFFECT ON 4 SEXUAL FUNCTION DOMAINS COMPARED WITH APPRECIABLE WORSENING OF SEXUAL FUNCTION AFTER LONG-TERM SINGLE OR COMBINATION DRUG USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154649 | REZUM | UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |