This study aimed at reporting a head-to-head comparison between water vapor thermal therapy using the Rezūm? system and prostatic urethral lift using the Urolift? system in men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).
Patients and methodsFrom December 2017 to November 2019, consecutive patients who underwent Rezūm? and Urolift? procedures in two urology centers have been retrospectively considered. Only patients with a prostate size less than 80 mL were included. We used the PSM method to adjust baseline differences between both groups. The co-primary endpoint included the change in International Prostate Symptom Score (IPSS) and IPSS- quality of life (QoL) from baseline to 12 months.
ResultsA total of 61 (52.1%) and 56 (47.9%) patients underwent Rezum? and Urolift? procedures, respectively. After PSM adjustment, 24 patients were included in both groups. No serious adverse events occurred (>?Clavien II) in both groups. At 12 months, higher IPSS improvement was observed in the Rezum? group (median:4 [IQR 3–5]) than in the Urolift? group (median:8 [IQR 7–12]), without statistical difference (p?=?0.08). The improvement in term of QoL at 12 m was similar (p?=?0.43). The retreatment rates were 25% (Urolift?) and 8.3% (Rezum?), p?=?0.24. Erection and ejaculatory function scores did not change significantly in either treatment group. Results in the full cohort showed that Rezum? appeared to deliver greater improvements for IPSS and IPSS-QoL (p?<?0.001 and p?=?0.006, respectively) and lower reintervention rate (p?=?0.006) than Urolift?.
ConclusionsIn this small retrospective study, our results indicate that both Rezum? and Urolift? provide a clinically significant improvement in symptoms and QoL, although some of these improvements were greater in the Rezum? arm. Future studies are needed to definitively assess which treatment would be best suited for each patient.
相似文献Objective
To explore efficacy and safety of Botulinum Neurotoxin Type A (BoNT-A) prostatic injection in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperperplasia.Materials and methods
A phase 3 multicenter open-labeled study randomised patients to receive BoNT-A prostatic injection or optimized medical therapy. BoNT-A injection consisted in trans-rectal injections of 200 UI in the transitional zone of the prostate. Optimal medical therapy consisted in oral medication with any drug patented for LUTS. One month (M1) after randomisation patients in the BoNT-A group were asked to stop any medical therapy related to LUTS. The main judgment criterion was the IPSS score at M4. Per-protocol analysis was performed with a non-inferiority hypothesis (ΔIPSS < 3).Results
127 patients were randomised to BoNT-A (n = 64) or medical therapy (n = 63). At randomisation mean IPSS was 16.9 ± 7.2 in the BoNT-A group vs 15.7 ± 7.3 in control. In the BoNT-A group, 44 patients (73.3%) could interrupt medical therapy for LUTS from M1 to M4. At M4, mean IPSS score was 12.0 ± 6.7 in the BoNT-A group vs 11.8 ± 6.9 in control. After adjustment for baseline IPSS, delta IPSS between groups was 0.01; 95% CI [? 2.14; 2.11] leading to accept the non-inferiority hypothesis.Conclusions
Four months after BoNT-A injection, most of the patients could interrupt LUTS-related medical treatments. In these patients, IPSS improvement was not inferior to optimized medical treatment, but the study design did not allow to conclude that this improvement was related with study drug rather than with sustained placebo effect.Trial registration
NCT01275521OBJECTIVE
- ? To evaluate the impact of urisheaths vs absorbent products (APs) on quality of life (QoL) in men with moderate to severe urinary incontinence (UI).
PATIENTS AND METHODS
- ? A randomized, controlled, crossover trial in 61 outpatient adult men with stable, moderate to severe UI, with no concomitant faecal incontinence, was conducted from June 2007 to February 2009 in 14 urology centres.
- ? Participants tested Conveen Optima urisheaths (Coloplast, Humlebaek, Denmark) with collecting bags and their usual AP in random order for 2 weeks each.
- ? The impact of each on QoL was measured using the King’s Health Questionnaire (KHQ) and the short form‐12 acute questionnaire, and each patient’s preference was recorded.
- ? A 10‐item patient questionnaire was also used to assess the product main advantages on an 11‐point scale (0: worst; 10: best). A 72‐h leakage diary was used to record the number and severity of leaks and daily product consumption. Safety was measured as the number of local adverse events.
RESULTS
- ? All dimensions of the KHQ were scored lower with urisheaths, indicating an improvement in QoL. The greatest mean score reductions were in Limitations of Daily Activities (?10.24, P= 0.01) and Incontinence Impact (?7.05, P= 0.045).
- ? The majority (69%) of patients preferred Conveen Optima urisheaths to their usual AP (P = 0.002).
- ? Urisheaths scored significantly higher for all categories in the patient questionnaire (efficacy, self‐image, odour management, discretion, skin integrity) except ease of use.
- ? Safety was considered to be good.
CONCLUSIONS
- ? Conveen Optima urisheaths showed a positive impact on QoL (according to the KHQ results) in moderate to severe incontinent men, who were long‐term users of APs, and participants largely preferred urisheaths.
- ? Conveen Optima urisheaths should be recommended to incontinent men in preference to APs.