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INTRODUCTION AND OBJECTIVE: Robotic assisted radical prostatectomy (RARP) is an invaluable whole gland treatment for intermediate, high-risk prostate cancer (PCa). However, a non-negligible proportion of these patients still harbour urinary incontinence and erectile disfunction after surgery. To assess the efficacy of our rehabilitation program in these patients. METHOD(S): A two arm, retrospective study on patients who underwent a RARP at a single institution in two pre-specified time intervals, namely March-July 2019 (study group) and March-July 2020 (control group), was conducted. Patients in the study group underwent a specific rehabilitation program, consisting of counseling with a prostate case-manager, an urologist and a physiotherapist, therefore starting pelvic floor muscle training (PFMT) at least 1-month before RARP. Due to the Covid-19 pandemic restrictions, this structured program was not delivered to the control group. The primary endpoint was the assessment functional outcomes at 30 days, 3 and 6 months after surgery. Continence recovery was defined as no use of pad, while erectile function (EF) recovery was defined as erection sufficient for an intercourse. Secondary endpoints included the following: surgical waiting time (SWT;period from prostate biopsy to surgery), biochemical recurrence (BCR) and/or imaging evidence of progression. RESULT(S): We included 249 patients, 136 (54.6%) in the study group and 113 (45.4%) in the control group. At 30 days after RARP, 49 (36.0%) patients in the study group were completely continent, and 6 (4.4%) had preserved EF as compared to 8 (7.1%) and 0 (0%) in the control group (p<0.001 and p=0.072 respectively). At 3 months, 131 (96.3%) were continent and 30 (22.1%) patients had recovery of EF in the study group, compared with 77 (68.14%) and 9 (8.0%) in the control group (p<0.001). Finally, at 6 months, 134 (98.5%) were continent and 50 (36.8%) had erection sufficient for intercourse in the study group, as compared with 96 (85.0%) and 19 (16.8%) in the control group (p<0.001). Median SWT was 2.9 (2.5-3.1) in 2019 and 5.8 (5.0-7.0) in 2020, (p<0.001). Median follow-up was 42 months (43-44) in the study group vs 32 (31-32) in the control group. No significant differences were observed in the proportion of patients experiencing BCR or imaging disease progression (8.1% vs 2.7%, p>=0.05). CONCLUSION(S): Our rehabilitation program is an valuable tool to enhance functional outcomes in patients undergoing RARP. Further prospective studies are still needed to confirm our results.
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Purpose: Coronavirus disease 2019 (COVID-19) is a disease that can affect many of our organs, and its effects on the human body are still unknown. In this study, we aimed to find the answer to the question of whether erectile dysfunction (ED) develops in patients who had COVID-19. Material(s) and Method(s): This is a prospective study of 459 patients. Married male patients aged between 25 and 70 years and who were hospitalized and treated for COVID-19 were included in the study. The patients were divided into three groups as mild, moderate, and severe cases, according to the extent of the disease. Each patient was asked to complete the International Index of Erectile Function (IIEF) upon admission and 45 th and 90 th days after discharge. Admission, 45 th and 90 th values of IIEF were compared within itself. Result(s): Statistically significant differences were observed in the IIEF evaluations on admission and 45 th and 90 th days of the patients in the three groups. IIEF values of three patient groups displayed a decrease on the 45 th day with respect to admission, while the 90 th day values were higher in comparison to 45 th day, although still remained lower than the values of admission. Evaluation of the erectile function values of the patients revealed that IIEF values on admission decreased on 45 th and 90 th day values. Conclusion(s): We determined that COVID-19 affected IIEF values in male patients, which might cause ED by reducing erectile function values.Copyright © 2023 Wolters Kluwer Medknow Publications. All rights reserved.
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Introduction & Objectives: Robotic assisted radical prostatectomy (RARP) is an invaluable whole gland treatment for intermediate, high-risk prostate cancer (PCa). However, a non-negligible proportion of these patients still harbour urinary incontinence and erectile disfunction after surgery. To assess the efficacy of our rehabilitation program among patient with intermediate, high-risk PCa underwent RARP. Material(s) and Method(s): A two arm, retrospective study on patients who underwent a RARP at a single institution in two time intervals, namely March-July 2019 (study group) and March-July 2020 (control group), was conducted. Patients in the study group underwent a specific rehabilitation program, consisting of counseling with a prostate case-manager, an urologist and a physiotherapist, therefore starting pelvic floor muscle training (PFMT) at least 1-month before RARP. Due to the Covid-19 pandemic restrictions, this structured program was not delivered to the control group. The primary endpoint was the assessment functional outcomes at 30 days, 3 and 6 months after surgery. Continence recovery was defined as no use of pad, while erectile function (EF) recovery was defined as erection sufficient for an intercourse. Secondary endpoints included the following: surgical waiting time (SWT), defined as period from prostate biopsy to surgery and oncological outcomes, defined as biochemical recurrence (BCR) and/or imaging evidence of progression. Result(s): We included 249 patients, 136 (54.6%) in the study group and 113 (45.4%) in the control group. No significant differences in baseline characteristics, clinical and pathological features were observed between the two groups. At 30 days after RARP, 49 (36.0%) patients in the study group were completely continent, and 6 (4.4%) had preserved EF as compared to 8 (7.1%) and 0 (0%) in the control group (p <0.001 and p=0.072 respectively). At 3 months, 131 (96.3%) were fully continent and 30 (22.1%) patients had full recovery of EF in the study group, compared with 77 (68.14%) and 9 (8.0%) in the control group (p <0.001). Finally, at 6 months, 134 (98.5%) were continent and 50 (36.8%) had erection sufficient for intercourse in the study group, as compared with 96 (85.0%) and 19 (16.8%) in the control group (p <0.001). Median SWT was 2.9 (2.5-3.1) in 2019 and 5.8 (5.0-7.0) in 2020, (p<0.001). Median follow-up was 42 months (43-44) in the study group vs 32 (31-32) in the control group. No significant differences were observed in the proportion of patients experiencing BCR or disease progression between the two groups (8.1% vs 2.7%, p>=0.05). Conclusion(s): Our rehabilitation program appears to be a valuable tool to enhance functional outcomes in patients undergoing RARP. Further prospective studies on larger populations are still needed to confirm our results.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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INTRODUCTION AND OBJECTIVE: BPH affects tens of millions of men across the world. Most procedures require either general or regional anesthesia or a transurethral approach. Herein, we present the 3 & 6 months results of NCT04760483 is a phase I prospective, single center, interventional pilot study evaluating transperineal laser ablation (TPLA) of BPH tissues, carried in Office setting under local anesthesia. A detailed step by step video depiction of this procedure is available at the AUA video library. The objectives call for safety, feasibility, and impact in pertinent outcomes measures, such as Uroflowmetry, IPSS, Hematuria, Erectile function, and ejaculation METHODS: The study contemplated accrual of 20 men between 50 and 80 years with prostate volumes between 30 and 120 cc, IPSS scores >9, peak flows between 5 and 15 cc/s and void residuals under <250 ml. Any patient neurological conditions, history of any surgical intervention or urinary retention were excluded. IPSS assessments, Flow studies and prostate volume measures were conducted at 3 months. Herein we present the results. Bayesian analysis for continuous measurements were performed and non-parametric differences were evaluated using chi2 tests. RESULTS: Patients enrolled between December 2020 and February of 2021. The median (IQR) for age and BMI was 68 (58,73) and 29 (27,31), respectively. These parameters for room time, ablation time, watts and total joules were 29 (23,32), 9 minutes (7,12), 6 (5,7) watts and 3,400 (2,600, 3600) joules, respectively. 8(40%) were discharged with a Foley due to elevated residuals. 16 patients had erections and ejaculations before and 3 months after TPLA. 17/20 (85%) had significant improvement in their urinary profile after TPLA (See TABLE for details). One of the initial responders suffered from COVID- 19 infection and developed a CVA that hindered his urinary function. CONCLUSIONS: TPLA in the office setting is feasible and safe. Three month outcomes showed subjective and objective sustained improvement in over 80% of patients for at least 6 months. Furthermore, erections or ejaculations were not affected. This novel and promising approach demands further evaluation in phase II-III trials. (Figure Presented).
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Introduction: High-Intensity Focused Electromagnetic (HIFEM) field technology utilizes rapidly changing magnetic fields that generate electrical currents in the underlying tissue where it depolarizes motor neurons and causes muscle contractions. BTL Emsella provides non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female incontinence. Novel protocol U2 is intended for men and uses a field intensity max of 2.5 T and a 10 cm depth of penetration for 28 minutes. Objective: Determine the effects of High-Intensity Focused Electromagnetic (HIFEM) field technology on the intensity and duration of ejaculation in men, with additional observations on erectile function using the IIEF-15 and urination using the IPSS. Methods: We looked at the effects of HIFEM on ejaculation, erectile function, and urination. Our IRB-approved protocol was one 28 minutes pelvic floor treatment per week for 4 weeks. At baseline, end of treatment, and one month post-treatment, the patient completed the IIEF-15, IPSS, and the LuBE Score, a four-question 5 point Likert style questionnaire created specifically for this study to investigate patient-reported aspects of orgasm, including volume, force, duration, and intensity of ejaculation. 0 is no change, 1 is increased, 2 is dramatically increased, -1 is decreased, -2 is dramatically decreased. Men participated with their sexual partners who also received four weekly treatments. Results: 12 men, average age of 57, completed the protocol. The range of the LuBE score is -8 to 8. The LuBE Score increased from baseline 0 up to 2.1 (median is 3 with a range of -1 to 5) to 2.7 (median of 3 with a range of 0 to 4) one month after the completion of treatment. The IIEF-15 increased from 54 at baseline to 60.3 at the completion of treatment and 60.4 one month after the completion of treatment. The IPSS declined from 7.1 to 4.6 at the completion of treatment and down to 3.3 one month after th Conclusions: We conclude that the U2 protocol for HIFEM boosts the strength of the bulbocavernosus and ischiocavernosus muscle and the pelvic floor resulting in an increase in volume, force, duration and intensity of ejaculation. In addition, there was a six-point increase in IIEF-15 score. There was a 3 to 4 point drop in IPSS score. We were surprised to see improvements in IIEF-15 and IPSS, and this should be investigated further. COVID limited patient recruitment, but the results indicate that pelvic HIFEM potentially improves ejaculation. Based on patient communications, I believe that more treatments than the four provided will add to the benefits. I plan on studies with more participants and extended treatment sessions. Disclosure: Yes, this is sponsored by industry/sponsor: BTL Clarification: No industry support in study design or execution Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science
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Introduction & Objectives: Robot-assisted Radical Prostatectomy (RARP) is an effective cure for organ confined prostate cancer but is associated with considerable post-operative functional toxicity. The NeuroSAFE technique (intra-operative frozen section analysis of the neurovascular structure adjacent margin) may help improve functional outcomes by promoting optimal nerve-sparing (NS) RARP without compromising on oncological outcomes. NeuroSAFE technique has reported favourably in retrospective, single-centre studies but has never been evaluated prospectively by a randomised study. The NeuroSAFE PROOF Feasibility Study has succeeded in demonstrating feasibility and has been succeeded by the fully powered, definitive NeuroSAFE PROOF Randomized Controlled Trial (RCT) (NCT03317990). Materials & Methods: Potent men (IIEF-5>21) with localised prostate cancer at 4 regional uro-oncology centres in the UK (UCLH, Bristol, Sheffield and Glasgow) are eligible. Participants are randomised 1:1 to RARP with NS decision guided by standard of care (clinical information, DRE and pre-operative mpMRI surgical plan) vs. RARP with NS decision guided by standard of care information and the NeuroSAFE technique. The primary outcome is erectile function (EF) recovery assessed by IIEF-5 score at 12-months. Important secondary outcomes include detailed peri-operative outcomes, histological outcomes, post-operative complications, biochemical recurrence rates, urinary continence (assessed by ICIQ), health related quality of life (assessed by Rand-36 and EQ-5D-5L), and health economics. In order to demonstrate a difference of 15% in EF recovery rates between the arms, a total of 404 men will be randomised and treated. Patient follow-up will continue for 5 years after RARP. Results: At the time of writing, 160 men have been recruited and treated with RARP as per random allocation at 4 participating sites. The independent DMC has met twice to ensure the oncological safety of the trial and will continue to review the data at intervals. Covid-19 has led to significant challenges, including suspension of recruitment and difficulties performing follow-up. The trial team have developed new methods of recruitment, consent and follow-up to ensure conduct of the study remains in line with the highest standards of trial conduct, including electronic remote consent processes and remote collection of PROMs. Conclusions: The NeuroSAFE technique has been reported as a method to optimise outcomes for men undergoing RARP for over a decade, but, in the absence of Level 1 evidence, equipoise remains. Despite the Covid-19 pandemic recruitment continues to be favourable. We hope that our
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Background Adults with sickle cell disease (SCD) face unique fertility risks due to SCD and use of disease modifying therapies (DMTs). Concerns about compromising fertility may inform patients' therapy choices, but little is known about fertility knowledge in adults with SCD. The Cardiff Fertility Knowledge Scale (CFKS) and Fertility Treatment Perception Survey have been studied in international and national cohorts 1,2. The purpose of this study was to administer these surveys to adults with SCD and compare responses to previously studied populations. Methods Our IRB approved this cross-sectional study of adults with SCD (≥18YO) cared for at our Sickle Cell Center for Adults. Due to the COVID-19 pandemic, eligible subjects were recruited during routine telemedicine clinic visits and by invitation via electronic medical record. We collected demographic information (sex, age (≥/< 31YO), educational attainment, and use of DMTs). The CFKS is a 13-question survey that measures knowledge of causes of reduced fertility, common misconceptions about fertility, and infertility facts. Questions are answered True/False/Don't know and equally weighted;the cumulative score is 0-100%. We compared the mean CFKS scores to the scores from two published cohorts 1,2. The fertility treatment perception survey consists of two positive and four negative statements about fertility treatment with responses given on a five-point Likert scale (1= strongly disagree to 5= strongly agree). Responses are calculated by number of respondents with an agreement score of 4 and/or 5 divided by total number of respondents per sub-group;higher scores indicate stronger agreement. Analysis included summary statistics with means and standard deviations and independent student's T-test to compare the mean fertility knowledge scores. Results We contacted 435 subjects;91 respondents were enrolled (21% response rate). Respondents were 77% female [median age 33 years (IQR 23, 50)]. 51% completed high school or less and 18% used one or more DMTs, with 65% taking hydroxyurea. Table 1 shows the CFKS results. The average CFKS score was 50%, lower than the international cohort (50% vs. 57%, p<0.001) and higher than a cohort of Black women in Atlanta, GA (50% vs. 38%, p<0.001). Respondents with higher educational attainment had a higher score (55% secondary education vs. 44% primary education, p=0.04). The questions most answered correctly addressed the lack of correlation between erectile function and fertility (79%) and smoking's risk to fertility in men (69%) and women (71%). The questions least answered correctly were about classifying infertility (32%) and the impact of age effect (34%), overweight effect (25%), and sexually transmitted infections' effect on fertility (36%). There was no difference in knowledge scores by age, sex, or SCD treatment. Table 2 shows fertility treatment perception survey results. Some respondents (34%) agreed that fertility treatments are safe. Almost half (46%) agreed that fertility treatments are effective. Over 60% of respondents agreed that fertility treatments are scary and/or cause emotional problems, while 48% agreed that fertility treatments may have short-term physical effects. There was no difference in responses by sex, age, or SCD treatment. Conclusion In this study, we identify that higher educational attainment in adults with SCD is associated with better fertility knowledge. All subjects had low knowledge of sexually transmitted infections, weight gain, and older age as infertility risks. Although there is concern that hydroxyurea may compromise fertility, its use was not associated with greater fertility knowledge in this study. Given concerns about fertility in the SCD community, we identify an opportunity to support patients concerned about fertility by contextualizing real or theorized SCD-specific fertility risks within a broader set of established fertility risks. References: 1. Bunting L, Tsibulsky I, Boivin J. Fertility knowledge and beliefs about fertility treatment: findings from the International Fer ility Decision-making Study. Hum Reprod. 2013 Feb;28(2):385-97. doi: 10.1093/humrep/des402. Epub 2012 Nov 25. PMID: 23184181. 2. Wiltshire A, Brayboy LM, Phillips K, et al. Infertility knowledge and treatment beliefs among African American women in an urban community. Contracept Reprod Med. 2019 Sep 24;4:16. doi: 10.1186/s40834-019-0097-x. PMCID: PMC6757383. [Formula presented] Disclosures: Lanzkron: Shire: Research Funding;GBT: Research Funding;Novo Nordisk: Consultancy;CSL Behring: Research Funding;Pfizer: Current holder of individual stocks in a privately-held company;Teva: Current holder of individual stocks in a privately-held company;Novartis: Research Funding;Bluebird Bio: Consultancy;Imara: Research Funding.