Water Vapor Thermal Therapy in Men With Prostate Volume ≥80 cm3: A Systematic Review and Meta-Analysis.

OBJECTIVE: To determine the safety and effectiveness of water vapor thermal therapy (Rezum) in men with large prostate volumes of at least 80cm3. METHODS: We performed systematic searches for studies of Rezum therapy in men with prostate volume of at least 80 cm3. Meta-analysis outcomes included the International Prostate Symptom Score (IPSS), IPSS Quality of Life (IPSS-QOL), Qmax, postvoid residual, International Index of Erectile Function-Erectile Function (IIEF-EF), and serious (Clavien-Dindo grade III-V) complications, surgical retreatments. Outcomes were analyzed using a random effects meta-analysis model. RESULTS: The review included 15 studies (11 retrospective) of 471 men with prostate volume at least 80 cm3 treated with Rezum therapy and followed for a median of 6months (range: 3-17months). Rezum therapy resulted in statistically significant improvements in IPSS (mean change: -11.0; 95% CI: -12.2, -9.7; P < .001), IPSS-QOL (mean change: -2.9; 95% CI: -3.5, -2.4; P < .001), Qmax (mean change: 6.5 mL/s; 95% CI: 4.8, 8.2 mL/s; P < .001), and postvoid residual (mean change: -101 mL; 95% CI: -145, -57; P < .001). No change in IIEF-EF was observed (mean change: 0.3; 95% CI: -1.1, 1.6; P = .71). Serious complications occurred in <0.1% (95% CI: 0.0%, 0.4%) and surgical retreatment in 1.2% (95% CI: 0.0%, 3.5%) of patients. CONCLUSION: Rezum therapy provides a statistically significant and clinically important short-term improvement in lower urinary tract symptoms with low complication rates in men with prostate volume of at least 80 cm3. Long-term outcomes with Rezum therapy in large prostates remain unclear.

Prospective Trial of Water Vapor Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia in Subjects with a Large Prostate: 6- and 12-month Outcomes.

Background: Current guidelines recommend Rezum water vapor thermal therapy for the treatment of benign prostatic hyperplasia (BPH) for prostate glands ranging in volume from 30 to 80 cm3. Few prospective studies have specifically evaluated the use of Rezum for larger prostates. Objective: To evaluate the safety and efficacy of water vapor thermal therapy in patients with a prostate gland >80 cm3 and ≤150 cm3. Design setting and participants: In this prospective, single-arm study at seven centers in the USA, subjects were males aged >50 yr with symptomatic BPH and prostate volume of >80 cm3 and ≤150 cm3. Intervention: Rezum was used to deliver sterile water vapor via a transurethral approach to ablate targeted areas of prostate tissue. Outcome measurements and statistical analysis: The primary efficacy outcome was response to therapy, defined on a per-patient basis as a ≥30% improvement in International Prostate Symptom Score (IPSS) from baseline to 6 mo. The primary safety outcome was a composite of serious device-related safety events. Secondary outcomes included catheterization for device-related retention. IPSS outcomes over time were analyzed via generalized estimating equations. Results and limitations: Among 47 eligible patients, prostate volume ranged from 80.8 to 148.1 cm3. All patients completed 6-mo follow-up, and 40/47completed 12-mo follow-up. At 6 mo, 83% were treatment responders according to the primary efficacy endpoint. The mean IPSS improvement at 6 mo was 11.9 ± 7.5 points, reflecting significant improvement. The primary safety outcome was met, with no occurrence of device-related composite safety events. The study is limited by the nonrandomized design and early termination, unrelated to safety or effectiveness. Conclusions: Our results are consistent with previous findings for prostate glands of up to 80 cm3, and indicate the safety and efficacy of Rezum for BPH in patients with a larger prostate. Patient summary: Rezum therapy, in which water vapor is used to treat targeted areas of the prostate, is currently recommended for patients with benign enlargement of the prostate and a prostate size of up to 80 cm3. We found that this treatment was also effective and safe in patients with a larger prostate of 80-150 cm3.

Minimally Invasive Treatments for Benign Prostatic Obstruction: A Systematic Review and Network Meta-analysis.

CONTEXT: Minimally invasive surgical therapies for male lower urinary tract symptoms secondary to benign prostatic obstruction were developed to be safer and more tolerable than standard ablative techniques. These treatments have not been compared with each other in a randomised fashion, and for some treatments, there are no trials against a reference technique. OBJECTIVE: To compare the efficacy, safety, and tolerability of water vapour thermal therapy (WVTT), prostatic urethral lift (PUL), prostatic arterial embolisation (PAE), temporary implantable nitinol device (iTIND), transurethral microwave thermotherapy (TUMT), and transurethral resection of the prostate (TURP). EVIDENCE ACQUISITION: A systematic search of MEDLINE/PubMed, Embase, Cochrane Library, and grey literature for randomised controlled trials was performed. Trials meeting the selection criteria were assessed for the risk of bias using the Cochrane RoB2 tool. Treatments were compared, using a network meta-analysis, in terms of outcomes including symptom score, quality of life, maximum urinary flow rate, postvoid residual urine, International Index of Erectile Function (IIEF-5), and scales from the Male Sexual Health Questionnaire. EVIDENCE SYNTHESIS: The search identified 63 trials. Symptoms and quality of life for PAE, PUL, and WVTT appeared similar to those for TURP, whereas TURP was found to have the most clinically significant improvement in flow rate. TUMT was less efficacious than TURP but provided similar results on quality of life. Comparisons of ejaculatory function favoured WVTT and PUL compared with TURP. The relative efficacy of iTIND was less clear because of the risk of bias in the respective trial. CONCLUSIONS: PAE, PUL, and WVTT appear favourable from a risk-benefit perspective despite probably having less efficacy than TURP for objective outcomes. These findings warrant confirmation through long-term randomised controlled trials. PATIENT SUMMARY: This paper has summarised the evidence from 63 clinical trials on minimally invasive surgical therapies for men with symptoms of an enlarged prostate, including water vapour thermal therapy (WVTT), prostatic urethral lift (PUL), prostatic arterial embolisation (PAE), temporary implantable nitinol device, and transurethral microwave thermotherapy (TUMT). Improvement in symptoms for each of PAE, PUL, TUMT, and WVTT in short-term follow-up was similar to that for the standard surgical treatment, although standard surgery appeared to provide the greatest increase in urine flow. Men who had WVTT or PUL were less likely to have problems with sexual function than those who had standard surgery.

The Efficacy and Safety of Laser and Electrosurgical Transurethral Procedures for the Treatment of BPO in High-Risk Patients: A Systematic Review.

Objective: To compare efficacy and safety outcomes of GreenLight, Holmium and Thulium laser  techniques with standard monopolar and bipolar transurethral resection of the prostate (TURP) in high-risk patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). Methods: We conducted a systematic literature review of studies in patients undergoing BPO surgeries who may be considered high-risk for standard TURP, with higher risk defined as follows: large prostates (≥80 mL) and/or taking antithrombotic agents and/or urinary retention and/or age >80 years and/or significant comorbidity.  Outcomes summarised included bleeding complications, re-intervention rates, hospital length of stay, and standard measures of disease and symptom severity for all available timepoints. Results: A total of 276 studies of 32,722 patients reported relevant data. Studies were heterogeneous in methodology, population and outcomes reported. IPSS reduction, Qmax improvement and PVR were similar across all interventions. Mean values at baseline and after 12 months across interventions were 13.2-29 falling to 2.3-10.8 for IPSS, 0-19 mL/s increasing to 7.5-34.1 mL/s for Qmax and 41.4-954 mL falling to 5.1-138.3 mL for PVR. Laser treatments show some advantages compared with monopolar and bipolar TURP for some adverse events and safety parameters such as bleeding complications. Duration of hospital stay, reinterventions and recatheterisations were lower with GreenLight, HoLEP, Thulium lasers, and bipolar enucleation than TURP. Conclusions: Laser therapies are effective and well-tolerated treatment options in high-risk patients with BPO compared with monopolar or bipolar TURP. The advantageous safety profile of laser treatments means that patients with a higher bleeding risk should be offered laser surgery preferentially to mTURP or bTURP.

Effectiveness of convective water vapor energy therapy versus prostatic urethral lift for symptomatic benign prostatic hyperplasia: a systematic review and indirect comparison.

PURPOSE: To synthesize the evidence from randomized controlled trials of prostatic urethral lift (PUL) and convective water vapor thermal energy therapy (WAVE) for minimally invasive treatment of men with benign prostatic hyperplasia. METHODS: A systematic search of databases was performed to identify trials comparing WAVE or PUL to either an active or sham surgery control in subjects with symptomatic benign prostatic obstruction. A controlled indirect treatment comparison based on the approach of Bucher was performed for outcomes including International Prostate Symptom Score and maximum urinary flow rate (Qmax). The durability of treatment response was assessed by life-table analysis of freedom from retreatment through 4 years. RESULTS: Two multicenter sham-controlled trials (Rezum II Study, NCT01912339: LIFT Study, NCT01294150) were identified. The trials employed a common sham procedure and were similar with respect to their designs and subjects' baseline characteristics. Comparisons on the treatment effect in excess of sham response found non-significant differences between WAVE and PUL for symptom score [mean difference (MD): - 1.7 points; 95% confidence interval (CI): - 4.8, 1.4] but Qmax improvements favored WAVE [MD: 3.4 ml/sec; CI: 1.2, 5.6]. The proportion free of retreatment through 4 years was 89.1% for WAVE versus 75.4% for PUL [log-rank P = 0.004]. CONCLUSIONS: PUL and WAVE provide similar subjective improvements but flow-rate improvement and durability of response seem greater for WAVE. The confirmation of these findings in a randomized trial is warranted.

Effect of therapeutic plasma exchange on coagulation parameters in patients on warfarin.

Therapeutic plasma exchange (TPE) without plasma replacement results in coagulation factor removal. Warfarin decreases the activity of vitamin K dependent coagulation factors. The combined effect of TPE and warfarin on the coagulation system has not been studied. A prospective, observational study was conducted in patients undergoing TPE while on warfarin. One plasma volume TPEs were performed on the COBE Spectra Apheresis System (Terumo BCT, Lakewood, CO) with 5% albumin. International normalized ratio (INR), fibrinogen, and factor II activity were obtained pre and post procedure. Eight patients underwent 121 TPEs that met study criteria with pre and post data. The average pre values were INR 2.09 ± 0.58, fibrinogen 263 ± 76 mg/dl, and factor II 29 ± 16% and the average post values were INR 4.12 ± 1.44, fibrinogen 105 ± 31 mg/dl, and factor II 13 ± 7%. The pre-INR was ≥2.00 for 55% of TPEs. The pre value (Y0 ) predicts the post value (Y) by the following equations Y = -0.54 + 2.21Y0 , Y =12.10 + 0.35Y0, and Y =1.83 + 0.39Y0 for INR, fibrinogen, and factor II respectively. In conclusion, pre procedure laboratory values can predict the post laboratory values for patients on warfarin receiving single plasma volume TPE with albumin replacement. The post-INR is approximately twice the pre-INR. At normal and mildly elevated pre-INR, the effect of TPE on the INR is less marked. A single plasma volume TPE decreases the plasma level by ∼65% for fibrinogen and 60% for factor II.