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Efficacy and Safety of Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
C. Dixon, ER. Cedano, D. Pacik, V. Vit, G. Varga, L. Wagrell, M. Tornblom, L. Mynderse, T. Larson,
Language English Country United States
Document type Clinical Trial, Journal Article, Multicenter Study
- MeSH
- Patient Safety MeSH
- Risk Assessment MeSH
- Prostatic Hyperplasia complications diagnosis surgery MeSH
- Internationality MeSH
- Confidence Intervals MeSH
- Laser Therapy instrumentation methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Minimally Invasive Surgical Procedures methods MeSH
- Follow-Up Studies MeSH
- Recovery of Function MeSH
- Pilot Projects MeSH
- Prospective Studies MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Lower Urinary Tract Symptoms etiology physiopathology surgery MeSH
- Transurethral Resection of Prostate methods MeSH
- Urodynamics MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
OBJECTIVE: To assess 1-year efficacy and safety data from pilot trials of the Rezūm System water vapor to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 65 men with symptoms of moderate to severe BPH were enrolled in pilot studies at centers in the Dominican Republic, the Czech Republic, and Sweden. Each patient was treated with transurethral delivery of sterile water vapor (steam). International Prostate Symptom Score (IPSS), peak urinary flow (Qmax), quality of life (QoL), postvoid residual, International Index of Erectile Function, and prostate-specific antigen were evaluated at 1 week and 1, 3, 6, and 12 months post-treatment. Safety was also assessed. RESULTS: Statistically significant clinical improvements at 1, 3, 6, and 12 months were reported for IPSS (decreased by 6.8, 13.4, 13.1, and 12.5 points, respectively) and Qmax (increased by 2.0, 4.7, 4.3, and 4.6 mL/sec, respectively). At 12 months, these results equated to a 56% improvement in IPSS (P <.001) and an 87% improvement in Qmax (P <.001). QoL also improved at 12 months with a 61% improvement. Sexual function was maintained. Most of the adverse events (AEs) were related to endoscopic instrumentation and were of short duration. One case of urinary retention was classified as a procedure/device-related serious AE. CONCLUSION: The Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.
Department of Urology Brno University Hospital Brno Czech Republic
Department of Urology Clinical Canela La Romana Dominican Republic
Department of Urology Lenox Hill Hospital New York NY
Department of Urology Mayo Clinic Rochester MN
References provided by Crossref.org
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- $a OBJECTIVE: To assess 1-year efficacy and safety data from pilot trials of the Rezūm System water vapor to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 65 men with symptoms of moderate to severe BPH were enrolled in pilot studies at centers in the Dominican Republic, the Czech Republic, and Sweden. Each patient was treated with transurethral delivery of sterile water vapor (steam). International Prostate Symptom Score (IPSS), peak urinary flow (Qmax), quality of life (QoL), postvoid residual, International Index of Erectile Function, and prostate-specific antigen were evaluated at 1 week and 1, 3, 6, and 12 months post-treatment. Safety was also assessed. RESULTS: Statistically significant clinical improvements at 1, 3, 6, and 12 months were reported for IPSS (decreased by 6.8, 13.4, 13.1, and 12.5 points, respectively) and Qmax (increased by 2.0, 4.7, 4.3, and 4.6 mL/sec, respectively). At 12 months, these results equated to a 56% improvement in IPSS (P <.001) and an 87% improvement in Qmax (P <.001). QoL also improved at 12 months with a 61% improvement. Sexual function was maintained. Most of the adverse events (AEs) were related to endoscopic instrumentation and were of short duration. One case of urinary retention was classified as a procedure/device-related serious AE. CONCLUSION: The Rezūm System provides effective relief of LUTS associated with BPH at 1 year. The procedure is safe with an acceptable side effect profile.
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