Novel minimally invasive treatments for lower urinary tract symptoms: a systematic review and network meta-analysis

ABSTRACT Purpose: To review and compare the effectivity of novel minimally invasive treatments (MITs) to transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) in men. Methods: Medline, Embase, and Cochrane databases were searched from January 2010 to December 2022 for randomized controlled trials (RCTs) evaluating MITs, compared to TURP or sham, in men with LUTS. Studies were assessed by risk of bias tool, and evidence by GRADE. Functional outcomes by means of uroflowmetry and IPSS were the primary outcomes, safety and sexual function were secondary outcomes. As part of this review, a network meta-analysis (NMA) was conducted. MITs were ranked based on functional outcome improvement probability. Results: In total, 10 RCTs were included, evaluating aquablation, prostatic urethral lift, prostatic artery embolization (PAE), convective water vapor thermal treatment or temporary implantable nitinol device. All MITs showed a better safety profile compared to TURP. Functional outcome improvement following aquablation were comparable to TURP. In the NMA, aquablation was ranked highest, PAE followed with the second highest probability to improve functional outcomes. Other novel MITs resulted in worse functional outcomes compared to TURP. Level of evidence was low to very low. Conclusions: Five MITs for treatment of LUTS were identified. Aquablation is likely to result in functional outcomes most comparable to TURP. Second in ranking was PAE, a technique that does not require general or spinal anesthesia. MITs have a better safety profile compared to TURP. However, due to high study heterogeneity, results should be interpreted with caution

Clinical applications of functional optical coherence tomography

The purpose of the work presented in this thesis is to show the potential of functional optical coherence tomography (OCT) to discriminate pathological from normal tissues in several clinical settings, by means of the attenuation coefficient. To that end, several fundamental studies were carried out to increase the fundamental understanding of the measured signals (in phantoms, during apoptosis) and both ex and in vivo investigations are performed in the urological and gynecological clinic

Validation of the electronic version of the international index of erectile function (IIEF-5 and IIEF-15): A crossover study

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application. OBJECTIVE: The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15. METHODS: This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient. RESULTS: A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively. CONCLUSIONS: We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version. TRIAL REGISTRATION: ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388

Validation of the electronic version of the international index of erectile function (IIEF-5 and IIEF-15):A crossover study

\u3cp\u3eBACKGROUND: Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application.\u3c/p\u3e\u3cp\u3eOBJECTIVE: The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15.\u3c/p\u3e\u3cp\u3eMETHODS: This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient.\u3c/p\u3e\u3cp\u3eRESULTS: A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively.\u3c/p\u3e\u3cp\u3eCONCLUSIONS: We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version.\u3c/p\u3e\u3cp\u3eTRIAL REGISTRATION: ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388.\u3c/p\u3

Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial

Introduction The current state-of-the-art treatment modality for hypertrophic capillary malformations (CMs), laser therapy, has a considerable rate of non-responders and recurrence. Intralesional bleomycin injections (or 'sclerotherapy') are commonly used to treat venous and lymphatic malformations with an excellent effect, but these intravascular injections are not possible in CMs due to the small diameter of the vessels. Electroporation-an electric field applied to the tissue-could increase the permeability of endothelial cells, which could theoretically facilitate targeted localised bleomycin delivery. We therefore hypothesise that bleomycin injections in combination with electroporation-'electrosclerotherapy' (EST), also known as 'electrochemotherapy'-could potentially be a novel alternative treatment option for CMs. Methods and analysis In this randomised within-patient controlled pilot trial, 20 patients with hypertrophic CMs will be enrolled. Three regions of interest (ROIs) within the CM will be randomly allocated for treatment with (A) EST, (B) bleomycin sclerotherapy without electroporation and (C) no treatment. Patients and outcome assessors are blinded for the treatment allocation. Treatment outcome for each ROI will be measured approximately 7 weeks after the treatment procedure, using patient-reported and physician-reported global assessment scores, colorimetry, laser speckle imaging and reporting of adverse events. Ethics and dissemination The study protocol is approved by the ethics review committee of the Academic Medical Center, Amsterdam. Results will be published in peerreviewed medical journals and will be presented at international conferences and scientific meetings. Study results will be fed back to the patient population through website and social media notification

MRI and CT in the follow-up after irreversible electroporation of small renal masses

PURPOSE Ablation plays a growing role in the treatment of small renal masses (SRMs) due to its nephron sparing properties and low invasiveness. Irreversible electroporation (IRE) has the potential, although still experimental, to overcome current limitations of thermal ablation. No prospective imaging studies exist of the ablation zone in the follow-up after renal IRE in humans. Objectives are to assess the use of computed tomography (CT) and magnetic resonance imaging (MRI) to determine the ablation zone volume (AZV), enhancement and imaging characteristics after renal IRE. METHODS This was a prospective phase 2 study of IRE in 9 patients with 10 SRMs. MRI was performed pre-IRE, 1 week, 3 months, 6 months, and 12 months after IRE. CT was performed pre-IRE, perioperatively (direct after ablation), 3 months, 6 months, and 12 months after IRE. AZVs were assessed by two independent observers. Observer variation was analyzed. Evolution of AZVs, and their relation with the needle configuration volume (NCV; indicating planned AZV) were evaluated based on CT and MRI measurements. RESULTS Eight SRMs were clear cell renal cell carcinomas, one SRM was a papillary renal cell carcinoma and one patient had a nondiagnostic biopsy. On CT, median AZV increased perioperatively until 3 months post-IRE (16.8 cm(3) and 6.2 cm(3), respectively) compared with the NCV (4.8 cm(3)). On MRI, median AZV increased 1 week post-IRE until 3 months post-IRE (14.5 cm(3) and 4.6 cm(3), respectively) compared with the NCV (4.8 cm3). At 6 months the AZV starts decreasing (CT 4.8 cm(3); MRI 3.0 cm(3)), continuing at 12 months (CT 4.2 cm(3), MRI 1.1 cm(3)). Strong correlation was demonstrated between the planned and the post-treatment volumes. Inter-observer agreement was excellent (CT: 95% CI 0.82-0.95; MRI: 95% CI 0.86-0.96). All SRMs appeared non-enhanced immediately after ablation, except for one residual tumor. Subtraction images confirmed non-enhancement on MRI in cases with unclear enhancement (3/9). Directly after IRE, gas bubbles, perinephric stranding, and edema were observed in all cases. CONCLUSION Both CT and MRI findings indicate increase of AZV until 3 months post-IRE, followed by gradual decrease in AZV from 6 to 12 months post-IRE. Enhancement is absent in cases with complete ablation. Gas bubbles, perinephric stranding, and edema are normal findings directly post-IRE.Netherlands Organization for Health Research and Developmen

Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial

\u3cp\u3eBackground: Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men's quality of life. Methods/Design: In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires. Discussion: There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE. Trial registration: Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14.\u3c/p\u3

Bladder cancer segmentation on multispectral images

\u3cp\u3eNonmuscle Invasive Bladder Cancer (NMIBC) has high incidence, and close follow-up with cystoscopy is necessary due to its high recurrence rate after initial treatment, estimated to be as high as 75%. Because of the high recurrence rate, it is vital that the detection of bladder cancer is improved. Computer automated detection algorithms have shown to be exceptionally effective in achieving this goal. This paper presents the first automated segmentation algorithm for bladder cancer in endoscopic images. The second purpose of this study is to determine which modality is best suited for computer-aided segmentation of bladder cancer. Gabor and color features are extracted from 20 patients in four different modalities with a block-based strategy. Three different classifiers are used to classify the blocks and post-processing is applied to obtain a segmented region. The best classification results were obtained by using a support vector machine and the Spectrum B modality. Additionally, color features were found to be effective for obtaining segmentations comparable to experts.\u3c/p\u3

Irreversible electroporation for the treatment of localized prostate cancer:a summary of imaging findings and treatment feedback

\u3cp\u3ePURPOSE: Imaging plays a crucial role in ablative therapies for prostate cancer (PCa). Irreversible electroporation (IRE) is a new treatment modality used for focal treatment of PCa. We aimed to demonstrate what imaging modalities can be used by descriptively reporting contrast-enhanced ultrasonography (CEUS), multiparametric magnetic resonance imaging (mpMRI), and grey-scale transrectal ultrasound (TRUS) results. Furthermore, we aimed to correlate quantitatively the ablation zone seen on mpMRI and CEUS with treatment planning to provide therapy feedback.\u3c/p\u3e\u3cp\u3eMETHODS: Imaging data was obtained from two prospective multicenter trials on IRE for localized low- to intermediate-risk PCa. The ablation zone volume (AZV) seen on mpMRI and CEUS was 3D reconstructed to correlate with the planned AZV.\u3c/p\u3e\u3cp\u3eRESULTS: Descriptive examples are provided using mpMRI, TRUS, and CEUS for treatment planning and follow-up after IRE. The mean AZV on T2-weighted imaging 4 weeks following IRE was 12.9 cm3 (standard deviation [SD]=7.0), 5.3 times larger than the planned AZV. Linear regression showed a positive correlation (r=0.76, P = 0.002). For CEUS the mean AZV was 20.7 cm3 (SD=8.7), 8.5 times larger than the planned AZV with a strong positive correlation (r=0.93, P = 0.001). Prostate volume is reduced over time (mean= -27.5%, SD=11.9%) due to ablation zone fibrosis and deformation, illustrated by 3D reconstruction.\u3c/p\u3e\u3cp\u3eCONCLUSION: The role of imaging in conjunction with IRE is of crucial importance to guide clinicians throughout the treatment protocol. CEUS and mpMRI may provide essential treatment feedback by visualizing the ablation zone dimensions and volume.\u3c/p\u3