madman
Super Moderator
Abstract
Purpose Rezūm is the latest developed minimally invasive treatment for benign prostatic hyperplasia (BPH). We aimed to carefully assess the functional outcomes of patients treated with Rezūm for BPH.
Methods We prospectively followed 135 consecutive patients treated by Rezūm at 5 institutions from June 2019 to August 2020. The International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF), the Overactive Bladder Questionnaire-Short Form (OAB-q SF) score, the International Index of Erectile Function (IIEF-5) and questions 9 and 10 to assess ejaculatory dysfunction were recorded. Election criteria were age>18, no prior prostate interventions, IPSS≥13, post-void residual≤250 mL, prostate volume between 30 and 120 ccs.
Results The median operative time was 10.5 (IQR 8.7–15) min. All patients were dismissed few hours after surgery with an indwelling urinary catheter that was removed after a median of 7 (IQR 7–10) days. A significant decrease of IPSS from baseline at first (p=0.001) and third (p<0.0001) months after surgery was reported. No difference was reported in terms of ICIQ-UI SF scores postoperatively. A mild reduction of the OAB-q SF score was reported at 1 month from surgery (p=0.06) that turned significant at 3 months postoperatively (p<0.0001). A slight but statistically significant increase of the IIEF-5 score was reported from baseline at 6 months (p=0.04). Postoperatively, patients reported a significant decrease in ejaculatory dysfunction after alpha-blocker interruption.
Conclusion Rezūm treatment is a feasible minimally invasive option for patients with BPH symptoms and showed optimally early functional outcomes.
Introduction
It is estimated that BPH currently affects 6% of the male population worldwide [2, 3]. Symptoms related to BPH increase proportionally with the age [1–3]. There is evidence from longitudinal studies that BPH is a progressive disease: prostate size increases, symptoms and health‐related quality of life worsen, flow rates deteriorate, and some men develop unfavorable outcomes such as acute urinary retention (AUR), or the need for surgery [4]. Several options exist for BPH management with a significant range of invasiveness, efficacy, and cost [5, 6].
Decision making varies according to the severity of symptoms, patients’ interest in sexual function preservation and clinical features such as prostatic length and volume (PV), prostatic urethral angle (PUA), median lobe (ML), elevated the central zone (ECZ), intravesical prostatic protrusion (IPP) patients’ pain tolerance and propensity to bleeding [5–8]. Minimally invasive surgical treatments (MISTs), both based on physical energy and mechanical expander options, represent alternative intervention before or after any pharmacotherapy [9–14].
The latest developed MIST is water vapor thermal therapy using radiofrequency to create thermal energy (Rezūm System, Boston Scientific, Marlborough, MA) in the form of water vapor [15–17].
The Rezūm treatment can be quickly performed under local anesthesia in an office setting. Steam is delivered to the hyperplastic prostatic tissue through a dedicated cystoscope for a short amount of time (9 s for each injection) leading to cell membrane disruption [15–17]. Within 3 months the treated tissue shrinks up to 40% and patients report relief of LUTS and enhanced quality of life without sexual function disturbance [15]. All zones of the prostate are amenable for treatment, including the intravesical median lobe [7]. The aim of this study is to present a detailed prospectively collected record of the functional outcomes of patients treated with Rezūm for benign prostatic hyperplasia.
*The Rezūm procedure
Rezūm treatment is not suitable for all patients. In particular, it has been cautiously contraindicated in patients with a urinary implant or penile prosthesis. The presence of recurrent or active urinary tract infection and/or urinary retention have been considered relative contraindications to treatment with Rezūm. Similarly, it is relatively not indicated in patients with previous prostate surgery, radiation treatment, or focal therapy. Marion’s disease or bladder neck stenosis is also a contraindication to this type of treatment. This study is not devoid of limitations. Although prospective in nature, it is a longitudinal cohort study with no control arm [25]. At present, there is a lack of data on long-term follow-up and the need for repeat or alternate procedures is unknown. However, even if more powered studies are awaited to adequately evaluate the retreatment rates, the impact on the quality of life, and the pharmacoeconomics, Rezūm showed good outcomes on early follow-up. Apart from being randomized, future studies also need to be independent of funding or support from the industry or commercial company to avoid any potential bias in their conduct.
Purpose Rezūm is the latest developed minimally invasive treatment for benign prostatic hyperplasia (BPH). We aimed to carefully assess the functional outcomes of patients treated with Rezūm for BPH.
Methods We prospectively followed 135 consecutive patients treated by Rezūm at 5 institutions from June 2019 to August 2020. The International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF), the Overactive Bladder Questionnaire-Short Form (OAB-q SF) score, the International Index of Erectile Function (IIEF-5) and questions 9 and 10 to assess ejaculatory dysfunction were recorded. Election criteria were age>18, no prior prostate interventions, IPSS≥13, post-void residual≤250 mL, prostate volume between 30 and 120 ccs.
Results The median operative time was 10.5 (IQR 8.7–15) min. All patients were dismissed few hours after surgery with an indwelling urinary catheter that was removed after a median of 7 (IQR 7–10) days. A significant decrease of IPSS from baseline at first (p=0.001) and third (p<0.0001) months after surgery was reported. No difference was reported in terms of ICIQ-UI SF scores postoperatively. A mild reduction of the OAB-q SF score was reported at 1 month from surgery (p=0.06) that turned significant at 3 months postoperatively (p<0.0001). A slight but statistically significant increase of the IIEF-5 score was reported from baseline at 6 months (p=0.04). Postoperatively, patients reported a significant decrease in ejaculatory dysfunction after alpha-blocker interruption.
Conclusion Rezūm treatment is a feasible minimally invasive option for patients with BPH symptoms and showed optimally early functional outcomes.
Introduction
It is estimated that BPH currently affects 6% of the male population worldwide [2, 3]. Symptoms related to BPH increase proportionally with the age [1–3]. There is evidence from longitudinal studies that BPH is a progressive disease: prostate size increases, symptoms and health‐related quality of life worsen, flow rates deteriorate, and some men develop unfavorable outcomes such as acute urinary retention (AUR), or the need for surgery [4]. Several options exist for BPH management with a significant range of invasiveness, efficacy, and cost [5, 6].
Decision making varies according to the severity of symptoms, patients’ interest in sexual function preservation and clinical features such as prostatic length and volume (PV), prostatic urethral angle (PUA), median lobe (ML), elevated the central zone (ECZ), intravesical prostatic protrusion (IPP) patients’ pain tolerance and propensity to bleeding [5–8]. Minimally invasive surgical treatments (MISTs), both based on physical energy and mechanical expander options, represent alternative intervention before or after any pharmacotherapy [9–14].
The latest developed MIST is water vapor thermal therapy using radiofrequency to create thermal energy (Rezūm System, Boston Scientific, Marlborough, MA) in the form of water vapor [15–17].
The Rezūm treatment can be quickly performed under local anesthesia in an office setting. Steam is delivered to the hyperplastic prostatic tissue through a dedicated cystoscope for a short amount of time (9 s for each injection) leading to cell membrane disruption [15–17]. Within 3 months the treated tissue shrinks up to 40% and patients report relief of LUTS and enhanced quality of life without sexual function disturbance [15]. All zones of the prostate are amenable for treatment, including the intravesical median lobe [7]. The aim of this study is to present a detailed prospectively collected record of the functional outcomes of patients treated with Rezūm for benign prostatic hyperplasia.
*The Rezūm procedure
Rezūm treatment is not suitable for all patients. In particular, it has been cautiously contraindicated in patients with a urinary implant or penile prosthesis. The presence of recurrent or active urinary tract infection and/or urinary retention have been considered relative contraindications to treatment with Rezūm. Similarly, it is relatively not indicated in patients with previous prostate surgery, radiation treatment, or focal therapy. Marion’s disease or bladder neck stenosis is also a contraindication to this type of treatment. This study is not devoid of limitations. Although prospective in nature, it is a longitudinal cohort study with no control arm [25]. At present, there is a lack of data on long-term follow-up and the need for repeat or alternate procedures is unknown. However, even if more powered studies are awaited to adequately evaluate the retreatment rates, the impact on the quality of life, and the pharmacoeconomics, Rezūm showed good outcomes on early follow-up. Apart from being randomized, future studies also need to be independent of funding or support from the industry or commercial company to avoid any potential bias in their conduct.
