Real-world evidence with the Prostatic Urethral Lift and Rezūm: a retrospective cohort study on the efficacy and durability in 12-month clinical outcomes
Mustufa Babar, BS, Matthew Ines, BS, Sandeep Singh, BS, Nazifa Iqbal, BA, Michael Ciatto, MD.
DSS Urology, Queens Village, NY.
BACKGROUND: The Prostatic Urethral Lift (PUL) and Rezūm are attractive minimally invasive treatment options for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia. PUL relies on a mechanical approach, using implants to create a continuous channel between the prostate's lateral lobes, while Rezūm relies on convective water vapor thermal energy to ablate the prostate's lateral and medial lobes. We report the first study analyzing 12-month real-world clinical outcomes between PUL and Rezūm.
METHODS: Clinical outcomes for the PUL group were obtained from published retrospective literature while those for the Rezūm group were obtained by conducting a retrospective study. International Prostate Symptom Score (IPSS) and Quality of Life (QoL) were assessed at 1-, 3-, 6-, and 12-month while maximum flow rate (Qmax) was assessed at 3-, 6-, and 12-month. Statistically significant differences between groups and from baseline to follow-up were determined using a two-sample t-test and paired t-test, respectively.
RESULTS: A total of 1413 patients were included in the PUL group and 219 patients were included in the Rezūm group. The PUL group had a higher mean baseline age (70.0 years), IPSS (19.0 points), Qmax (13.0 mL/s), and PVR (135.0 mL) when compared to the Rezūm group (63.3 years, 17.2 points, 11.5 mL/s, 29.2 mL, P<0.05). The Rezūm group had a higher mean baseline QoL (4.3 points) when compared to the PUL group (4.0 points, P<0.01). There were no significant differences in mean baseline prostate volume and PSA between the groups. Both groups saw significant improvements in IPSS and QoL as early as 1-month which remained durable to 12-month (P<0.01). At 1-month, the PUL group saw rapid percent changes in IPSS (-39%) and QoL (-43%) with maximum percent changes achieved at 3-month (-42%, -45%). The Rezūm group saw gradual improvements in IPSS and QoL with maximum percent changes in IPSS (-37%) and QoL (-44%) achieved at 6- and 12-month, respectively. Improvements in Qmax were durable to 12-month in the Rezūm group (P<0.01) and to 6-month in the PUL group (P=0.03). Maximum percent change in Qmax was seen at 3-month for the Rezūm group (117%) and at 6-month for the PUL group (36%).
CONCLUSIONS: Real-world application of PUL and Rezūm showed significant and durable improvements in LUTS and QoL up to 12 months. PUL demonstrated rapid relief in LUTS with maximum improvements achieved in 3 months while Rezūm yielded gradual relief with maximum improvements achieved in 6 months, suggesting that cell necrosis from water vapor treatments with Rezūm requires a longer healing period. However, Rezūm demonstrated greater and more durable improvements in flow rates.
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