ABSTRACT
BACKGROUND: Despite the existence of conservative therapies for Peyronie's disease (PD), surgery is commonly utilized for the treatment of bothersome curvatures due to its potential effectiveness, although it carries intrinsic risks and may not universally lead to satisfactory outcomes. AIM: To explore the rate and factors influencing patients' willingness to undergo surgery for PD. METHODS: Data were prospectively collected in 5 European academic centers between 2016 and 2020. Data included age, time from PD onset, penile pain, curvature degree, difficulty at penetration, hourglass deformity, erectile dysfunction (ED), and previous treatments. All patients were offered conservative treatments, either medications or injections. Tunical shortening or lengthening procedures were offered as an alternative to conservative treatments, when indicated. Penile prosthesis was offered to those with concomitant ED. Patients' attitudes with surgery were recorded. Logistic regression analyses tested the profile of patients who were more likely to be willing to undergo surgery. OUTCOMES: Patients' willingness to undergo surgery for PD. RESULTS: This study included 343 patients with a median age of 57.3 years (IQR, 49.8-63.6) and a median penile curvature of 40.0° (IQR, 30.0°-65.0°). Overall, 161 (47%) experienced penetration difficulties and 134 (39%) reported ED. Additionally, hourglass deformity and penile shortening were reported by 48 (14%) and 157 (46%), respectively. As for previous treatments, 128 (37%) received tadalafil once daily; 54 (16%) and 44 (13%), intraplaque verapamil and collagenase injections; and 30 (9%), low-intensity shock wave therapy. Significant curvature reduction (≥20°) was observed in 69 (20%) cases. Only 126 (37%) patients were open to surgery for PD when suggested. At logistic regression analysis after adjusting for confounders, younger age (odds ratio [OR], 0.97; 95% CI, 0.95-1.00; P = .02), more severe curvatures (OR, 1.04; 95% CI, 1.03-1.06; P < .0001), and difficulty in penetration (OR, 1.88; 95% CI, 1.04-3.41; P = .03) were associated with a greater attitude to consider surgical treatment. CLINICAL IMPLICATIONS: The need for effective nonsurgical treatments for PD is crucial, as is comprehensive patient counseling regarding surgical risks and benefits, particularly to younger males with severe curvatures. STRENGTHS AND LIMITATIONS: Main limitations are the cross-sectional design and the potential neglect of confounding factors. CONCLUSIONS: Patients with PD, having a lower inclination toward surgery, emphasize the need for effective nonsurgical alternatives and accurate counseling on the risks and benefits of PD surgery, particularly for younger men with severe curvatures.
Subject(s)
Erectile Dysfunction , Penile Implantation , Penile Induration , Male , Humans , Middle Aged , Cross-Sectional Studies , Penis/surgery , Treatment Outcome , Erectile Dysfunction/surgery , Erectile Dysfunction/complicationsABSTRACT
Background and Objectives: The relationship between male infertility (MI) and testicular cancer (TC) is bilateral. On one hand, it is well-established that patients diagnosed with TC have a high risk of pre- and post-treatment infertility. On the other hand, the risk of developing TC in male infertile patients is not clearly defined. The objective of this review is to analyze the histopathological, etiological, and epidemiological associations between MI and the risk of developing testicular cancer. This review aims to provide further insights and offer a guide for assessing the risk factors for TC in infertile men. Materials and Methods: A comprehensive literature search was conducted to identify relevant studies discussing the relationship between MI and the risk of developing TC. Results: The incidence rates of germ cell neoplasia in situ (GCNIS) appear to be high in infertile men, particularly in those with low sperm counts. Most epidemiological studies have found a statistically significant risk of developing TC among infertile men compared to the general or fertile male populations. The concept of Testicular Dysgenesis Syndrome provides an explanatory model for the common etiology of MI, TC, cryptorchidism, and hypospadias. Clinical findings such as a history of cryptorchidism could increase the risk of developing TC in infertile men. Scrotal ultrasound evaluation for testis lesions and microlithiasis is important in infertile men. Sperm analysis parameters can be useful in assessing the risk of TC among infertile men. In the future, sperm and serum microRNAs (miRNAs) may be utilized for the non-invasive early diagnosis of TC and GCNIS in infertile men. Conclusions: MI is indeed a risk factor for developing testicular cancer, as demonstrated by various studies. All infertile men should undergo a risk assessment using clinical examination, ultrasound, and semen parameters to evaluate their risk of TC.
Subject(s)
Cryptorchidism , Infertility, Male , Testicular Neoplasms , Humans , Male , Testicular Neoplasms/complications , Testicular Neoplasms/epidemiology , Cryptorchidism/complications , Cryptorchidism/epidemiology , Semen , Infertility, Male/epidemiology , Infertility, Male/etiologyABSTRACT
BACKGROUND: Some studies showed encouraging results on the efficacy and safety of penile traction therapy after Peyronie's disease (PD) surgery. The early traction therapy (ETT) could be an effective and safe approach to minimize penile shortening in patients undergoing PD surgery. AIM: To evaluate the feasibility, efficacy, and safety of a novel penile splint as ETT in patients with PD undergoing grafting techniques. METHODS: Patients with PD underwent plaque incision and grafting technique; at the end of the procedure, a novel penile splint (ETT) was applied to all patient. The device consisted of 2 10CH intubating stylets, self-adapted to each patient, that kept the penis stretched with the aid of non-absorbable sutures. The total expense for the materials needed to build each penile splint was less than 15 euros. This active traction was maintained for 1-3 weeks; then, we removed the stitches leaving the device on-site for a passive traction. Within 3-4 weeks from surgery, the penile splint was replaced by a standard penile traction device. OUTCOMES: The main outcomes evaluated at 6 months included stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse. RESULTS: A total of 46 patients were enrolled. The median preoperative IIEF-EF, penile curvature, and SPL were 27 points, 70°, and 13 cm, respectively. The median follow-up was 15 months. The median postoperative IIEF-EF was 25 points (P < .001). The median residual penile curvature was 10° (P < .001). The median postoperative SPL was 13 cm (P = .269). 8 patients (17.4%) lost 1 cm of SPL; no shortening greater than 1 cm was recorded. The median time to first satisfactory sexual intercourse and patient satisfaction score was 6 weeks and 9 points, respectively. CLINICAL IMPLICATIONS: Our results could pave the way for a new line of research, which in turn could lead to an improvement in the postoperative management of the patient undergoing surgery for PD. STRENGTH & LIMITATIONS: This is the first study evaluating the ETT after PD surgery. The main limitation of this study is the lack of a randomized control group. Other weaknesses are the small sample size and the short follow-up time. CONCLUSION: Our novel penile splint is inexpensive, easy to assemble, and adaptable to the patient. ETT using this novel device, followed by standard traction therapy, seems to be feasible, effective, and safe. Fernández-Pascual E, Manfredi C, Cocci A, et al. A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease. J Sex Med 2020;17:1819-1824.
Subject(s)
Penile Induration , Humans , Male , Patient Satisfaction , Penile Induration/surgery , Penis/surgery , Splints , Traction , Treatment OutcomeABSTRACT
BACKGROUND: A xenograft consisting of equine collagen coated with human fibrinogen and thrombin (TachoSil; Baxter, CA) has recently been introduced in grafting procedures for Peyronie's disease (PD). AIM: To describe the results of a multicenter prospective registry on patients with PD undergoing plaque incision or and grafting (PIG) or plaque excision and grafting (PEG) with collagen fleece TachoSil, to evaluate the efficacy and safety of this procedure. METHODS: A prospective non-controlled multicenter study of patients with PD was performed between May 2016 and March 2018. Patients from 10 centers with stable PD for at least 3 months, difficulties in sexual intercourse, normal erectile function with or without pharmacological treatment, curvature >45°, and/or penile shortening and/or complex deformities were included. All patients underwent PIG/PEG with collagen fleece TachoSil. OUTCOMES: The main outcome measure of this study were penile curvature correction (intraoperative), penile shortening (intraoperative), erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) and the Erection Hardness Score, subjective patient outcomes with non-validated questionnaires, and complications. RESULTS: A total of 52 patients were enrolled in the study. The mean (SD) preoperative penile curvature was 72.8° (17.0). PIG was the preferred technique (80.8%). Intraoperatively, complete curvature correction was achieved in 92.3%, and no significant penile shortening was recorded in 80.8% of subjects. Subjective penile shortening was reported in 83.3% of patients at 6 months. No objective measurement of penile curvature and length was recorded during follow-up. No statistically significant difference from the baseline was found in IIEF-5 and Erection Hardness Score at 3 or at 6 months, although 16.7% of men experienced a worsening of IIEF-5 scores and 14.3% required de novo phosphodiesterase type 5 inhibitor use. 6 months after surgery, 78.5% of men were satisfied with intervention. Swelling and ecchymosis/hematoma were the most common perioperative complications (40.4%). 2 cases (3.8%) of wound infection were recorded. At 6 months, 35.7% of patients reported mild penile hypesthesia. CLINICAL IMPLICATIONS: Our results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening. STRENGTH & LIMITATIONS: This is the first multicentre study on patients with PD undergoing grafting with TachoSil without concomitant placement of penile prosthesis. The main limitations are the short follow-up and the relatively small sample size. CONCLUSION: Grafting with TachoSil after PIG/PEG in patients with PD is an effective and safe procedure. Among the main advantages of this technique, there are ease of use of the graft and reduced operative time. Fernández-Pascual E, Manfredi C, Torremadé J, et al. Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease. J Sex Med 2020;17:2279-2286.
Subject(s)
Penile Induration , Animals , Collagen , Drug Combinations , Fibrinogen/therapeutic use , Horses , Humans , Male , Patient Satisfaction , Penile Induration/surgery , Penis , Prospective Studies , Thrombin , Treatment OutcomeABSTRACT
OBJECTIVES: To compare the efficacy and safety of a combined treatment of percutaneous needle tunnelling (PNT) and a modified collagenase Clostridium histolyticum (CCH) protocol (PNT/CCH) vs the modified protocol alone (CCH) in the treatment of Peyronie's disease (PD). PATIENTS AND METHODS: A prospective registry of patients treated with a modified CCH protocol was maintained between June 2014 and February 2018. The last 50 patients received PNT as an adjuvant therapy (PNT/CCH), and their data were compared with those of the other 94 patients treated previously (CCH). PNT involves the creation of multiple holes made percutaneously in the plaque before each injection. The modified protocol consisted of two collagenase injections, at 1-week intervals, followed by penile modelling. Patients used penile traction therapy, tadalafil and pentoxifylline for the next 2 months and were followed up for 6 months. The main outcome was improvement of curvature. Secondary outcomes were improvements in erectile function, PD symptoms, stretched penile length and satisfaction. RESULTS: Improvement in curvature was greater in patients in the PNT/CCH group than in the CCH group (mean ± sd 19.2 ± 6.1° vs 12.7 ± 5.0°; P < 0.001 [36.2 ± 12.5% vs 28.1 ± 14.5%; P = 0.001]). Compared with baseline, both interventions were associated with significant improvement in secondary outcomes. The main complications were ecchymosis, bruising and penile pain, with no significant differences between groups. CONCLUSIONS: Treatment of PD with CCH using our modified protocol in combination with PNT is safe and more effective than the modified protocol alone, with the potential for improved cost-effectiveness.
Subject(s)
Microbial Collagenase/administration & dosage , Penile Induration , Penis , Adult , Humans , Injections, Intralesional/adverse effects , Injections, Intralesional/methods , Male , Microbial Collagenase/therapeutic use , Middle Aged , Penile Induration/drug therapy , Penile Induration/physiopathology , Penile Induration/surgery , Penis/physiopathology , Penis/surgery , Prospective Studies , Treatment OutcomeABSTRACT
INTRODUCTION: Patients with Peyronie's disease (PD) and erectile dysfunction (ED) concomitant with shortening or other malformations benefit from prosthesis implantation and penile lengthening procedures. AIM: To evaluate the safety and efficacy of a multi-incisional technique with penile prosthesis implantation with multiple corporeal incisions and collagen grafting for the surgical management of complex cases of PD with ED and severe penile shortening. METHODS: From February 2015-May 2018, 43 consecutive patients with complex PD were treated using this technique. Implantation of a penile prosthesis (malleable or inflatable [IPP]) together with multiple relaxing tunica albuginea incisions and grafting with a self-adhesive collagen-fibrin fleece (TachoSil, Baxter Healthcare) was performed in all patients by a single surgeon (J.I.M.S.). MAIN OUTCOME MEASURE: Penile length and curvature correction, operative time, and incidence of postoperative complications were recorded as outcome measures. Functional outcomes were measured with questionnaires (International Index of Erectile Function-5, Erection Hardness Score, modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, PD Questionnaire) before and 3 and 6 months after surgery. RESULTS: With a median follow-up of 21 months (range 10-31), mean postsurgical penile lengthening was 2.5 (range 1-5) cm, with an improvement in the Bother domain of the PD Questionnaire of 4.4 (range 2-5) points. The average operative time was 86.7 and 71.6 minutes for the IPP and malleable penile prosthesis procedure, respectively. No glans ischemia was recorded; however, 1 IPP infection and 1 delayed distal corporeal erosion were recorded. Hematoma or bruising was observed in 23.2% of patients. The modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was completed by 39 (90.7%) patients. Overall, 89.7% would recommend this surgery. Patient satisfaction with straightness and length was 94.9% and 82.1%, respectively. CLINICAL IMPLICATIONS: The described technique helps restoration of penile length and erectile function in patients with complex PD. STRENGTHS & LIMITATIONS: The strength of the study is that it offers a simple, easy-to-apply technique for surgeons to correct shortening and other malformations in patients with ED and complex PD. The study is limited by the small number of patients, the short follow-up period and the performance of the technique by a single high-volume implanter. CONCLUSION: The implantation of a penile prosthesis (malleable or inflatable) together with multiple incisions of the plaque/tunica albuginea and grafting with a collagen fleece is a safe and efficient treatment for patients with complex PD in addition to ED and significant shortening. Fernández-Pascual E, Gonzalez-García FJ, Rodríguez-Monsalve M, et al. Surgical Technique for Complex Cases of Peyronie's Disease With Implantation of Penile Prosthesis, Multiple Corporeal Incisions, and Grafting With Collagen Fleece. J Sex Med 2019;16:323-332.
Subject(s)
Collagen/administration & dosage , Patient Satisfaction , Penile Implantation , Penile Induration/surgery , Humans , Male , Middle Aged , Penile Erection , Postoperative Complications , Surveys and Questionnaires , Transplants , Treatment OutcomeABSTRACT
The objective of this study was to evaluate and compare efficacy and safety of two different Disposable circumcision suture devices (DCSDs). A prospective comparative non-randomized multicenter study was performed between November 2019 and February 2023. Patients underwent circumcision using a DCSD (CircCurerTM or the ZSR® device) according to the surgeon preference and device availability. A total of 378 patients were circumcised; 184 using CircCurerTM and 194 patients using ZSR®. No differences in baseline characteristics were observed. CircCurer and ZSR Groups showed similar rates of operative time (7.7 ±2.1 vs 7.3 ±2.0 min), surgical site infection (1.1% Vs 1.5%), edema (13% Vs 8.2%), hematomas (2.7% Vs 1.1%), and postoperative pain (2.5 Vs 2.0 points). ZSR Group had a significantly higher rate of clip fallout (62.9% Vs 38%, p < 0.001). At 2 months, patients of both groups reported a median satisfaction of 9 (8-9) points. Main limitation consist in non-randomized study. DCSDs seem to be effective and safe, with short operative times, uncommon and mild complications, and high patient satisfaction. ZSR® device has a higher rate of spontaneous staple dropout.
ABSTRACT
Background: Cell therapy (CT) is a form of regenerative medicine under investigation for the management of male sexual dysfunction (MSD). Aim: We sought to perform a systematic review of published information on CT for MSD and provide an official position statements for the European Society for Sexual Medicine. Methods: A comprehensive bibliographic search on the MEDLINE, Web of Science, Scopus, and Cochrane Library databases was conducted in February 2023. Articles were selected based on the Population, Intervention, Comparator, Outcome, Study design (PICOS) model if they included male patients (P) undergoing CT (I) with or without comparison with other treatments (C) and evaluated the impact of CT on sexual function (O). Quantitative data were reported as found in the original studies (S). Level of evidence and grade of recommendation according to the Oxford Centre for Evidence-Based Medicine were assigned to each statement. Outcomes: Outcomes were determined based on assessment of erectile function, ejaculatory function, orgasmic function, sexual desire, and penile curvature. Results: A total of 19 studies and 421 patients were included. Most articles (n = 12, 63%) were case series, whereas a minority of papers (n = 6, 32%) had a comparative group; only 2 articles reported randomized controlled trials (RCTs) and 1 article reported a post hoc analysis of RCTs. Most articles (16, 84%) investigated patients with erectile dysfunction (ED). Improvements in the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) or the IIEF 5-item version (IIEF-5) were found in 11/15 (73%) studies, with mean increases in IIEF-EF, mean IIEF-5, and median IIEF-EF between 8 and 14 points, 2 and 9 points, and 4.5 and 6 points, respectively. Two papers (20%) evaluated men with Peyronie's disease (PD). In both ot these articles penile curvature improvement and plaque volume reduction were described in all patients (n = 16, 100%). Objective measurements were performed in 1 study, which showed 10°-120° (15%-100%) curvature improvement and 90%-100% plaque reduction. Mild transient adverse events at the donor or administration sites were found in 7/16 (44%) papers on ED. Priapism was reported in one case (20%) and mild penile skin complications were reported in the majority of patients after CT for PD. No severe adverse events were described. Clinical Implications: Although high-quality evidence is lacking, CT appears to have potential benefits from application in patients with ED or PD. Strengths and Limitations: This report is to our knowledge the most comprehensive and up-to-date systematic review on the topic of CT for the management of MSD, including the position statements of the European Society for Sexual Medicine. Overall the assessment of available studies demonstrated low quality and significant heterogeneity. Conclusion: Preliminary findings support potential efficacy and safety of CT in patients with ED or PD. Low-quality papers, high methodological heterogeneity, uncertainty about the magnitude of the beneficial effects, and lack of long-term data limit the available evidence.
ABSTRACT
The aim of this study was to evaluate the ability of Google Assistant, Alexa, and Siri to recognize and answer questions about male sexual health. Each VA was tested on a smart speaker: Alexa on Amazon Echo Dot 4th Gen., Google Assistant on Google Home Mini, and Siri on Apple HomePod. A pool of patients' frequently asked questions regarding erectile dysfunction (ED), premature ejaculation (PE), Peyronie's disease (PD), male infertility, and other aspects of male sexual health were identified by authors. The recognition of question was evaluated ("yes" or "not"). For each recognized question, the response characteristics (domains) were rated on a scale from 0 to 10 (according to the quality). We chose the recognition rate of the questions as the primary outcome and the quality of the answers as the secondary outcome. Overall, the best VA in recognizing questions was Siri, with a total of 83.3% questions compared with 64.0% for Alexa (p = 0.024) and 74.0% for Google Assistant (p = 0.061). Siri was associated with a significantly higher recognition rate than Alexa for PE (80% vs. 40%; p = 0.002) and PD (66.7% vs. 33.3%; p = 0.010). The quality of the responses was classified as low in 57 out of 105 cases (54.3%), intermediate in 46 cases (43.8%), and high in only 2 cases (1.9%), highlighting an overall intermediate-low quality of the answers. Male infertility was the condition associated with the highest mean scores in "Targeted response to the problem" (7.32 ± 2.57), "Scientific correctness of the answer", (5.9 ± 2.76) "Completeness of the answer" (5.14 ± 2.56), and "Understandability of the response for a patient" (5.3 ± 2.51) domains. Siri was associated with significantly higher scores than Alexa (p < 0.05) in several domains of all conditions evaluated. The question recognition rate of VAs is quite high; however, the quality of the answers is still intermediate-low. Siri seems superior to Alexa in both question recognition and response quality. Male infertility appears to be the sexual dysfunction best addressed by VAs.
Subject(s)
Erectile Dysfunction , Infertility, Male , Sexual Health , Voice , Humans , Male , ConsultantsABSTRACT
PURPOSE: To evaluate the preoperative and intraoperative risk factors for revision after artificial urinary sphincter (AUS) implantation in male patients with stress urinary incontinence (SUI). METHODS: A retrospective analysis from a prospectively maintained database was performed. Male patients, with moderate-tosevere SUI, undergoing AUS implantation were included. All patients underwent placement of AMS 800. Cause of revision, type of revision, and time to revision were recorded. Multivariable analyzes were performed using a logistic regression to investigate the risk factors. Competing risk analysis according to Fine-Gray model was used to study time to event data. RESULTS: A total of 70 patients were included. Revision surgery was performed in 22 of 70 patients (31.4%), after a median (interquartile range) time of 26.5 months (6.5-39.3 months). Overall, 19 of 22 repairs (86.4%) and 3 of 22 explants (13.6%) were recorded. Mechanical dysfunction, urethral erosion, urethral atrophy, and device infection were the causes of revision in 11 of 22 (50.0%), 6 of 22 (27.3%), 3 of 22 (13.6%), and 2 of 22 patients (9.1%). Vesicourethral anastomosis stenosis (P=0.02), urethral cuff size of 3.5 cm (P=0.029), and dual implantation (P=0.048) were independent predictors for revision. Vesicourethral anastomosis stenosis (P=0.01) and urethral cuff size of 3.5 cm (P=0.029) predicted a lower survival of the AUS. CONCLUSION: The vesicourethral anastomosis stenosis, urethral cuff size of 3.5 cm, and dual implantation are independent predictors for revision after AUS implantation. However, only the vesicourethral anastomosis stenosis and urethral cuff size of 3.5 cm predict a lower survival of AUS.
ABSTRACT
INTRODUCTION: The management of traumatic urethral strictures remains a challenge for urologists. Alteration of the pelvic anatomy and the significant fibrosis generated by the trauma make surgical repair complex. In most cases, the existing defect between the urethral ends is small, and the ideal treatment is end-to-end perineal urethroplasty. Cases of extensive strictures that are left with long gap defects may require the use of different sequential maneuvers to achieve a tension-free anastomosis. OBJECTIVE: To describe the experience at our center with urethral strictures induced by closed perineal trauma. MATERIALS AND METHODS: A retrospective analysis of 116 patients who underwent urethroplasty for urethral stricture after blunt perineal trauma at our center between 1965 and 2020 was conducted. Demographic data, date, mechanism of action of the trauma, emergency management, previous urethral interventions, surgical technique carried out in our center, complications, presence of erectile dysfunction, and urinary incontinence were collected. RESULTS: 82 patients (70.7%) presented with pelvic fractures. The most frequent etiology of trauma was traffic accidents (68%), followed by crushing injuries (24%). Suprapubic cystostomy was placed in 50.2% of patients, and urethral realignment was performed in 25.3%. The mean stricture length was 2.2 cm, affecting mostly the membranous urethra (67%). During surgery, it was necessary to perform crural separation in 61.5% and partial pubectomy in 18.8% of the cases. Erectile dysfunction developed after trauma in 40.5% of cases, while new erectile dysfunction was noted in 4.3% of patients after surgery. Surgery was successful in 91.3% of cases, with a median follow-up of 16 (6-47) months. CONCLUSION: Delayed anastomotic urethroplasty offers a high success rate in traumatic urethral strictures.
ABSTRACT
Targeted therapy (TT) for prostate cancer (PCa) aims to ablate the malignant lesion with an adequate margin of safety in order to obtain similar oncological outcomes, but with less toxicity than radical treatments. The main aim of this study was to evaluate the recurrence rate (RR) in patients with primary localized PCa undergoing mpMRI/US fusion targeted cryotherapy (FTC). A secondary objective was to evaluate prostate-specific antigen (PSA) as a predictor of recurrences. We designed a prospective single-center single-cohort study. Patients with primary localized PCa, mono or multifocal lesions, PSA ≤ 15 ng/mL, and a Gleason score (GS) ≤ 4 + 3 undergoing FTC were enrolled. RR was chosen as the primary outcome. Recurrence was defined as the presence of clinically significant prostate cancer in the treated areas. PSA values measured at different times were tested as predictors of recurrence. Continuous variables were assessed with the Bayesian t-test and categorical assessments with the chix-squared test. Univariate and logistic regression assessment were used for predictions. A total of 75 cases were included in the study. Ten subjects developed a recurrence (RR: 15.2%), while fifty-six (84.8%) patients showed a recurrence-free status. A %PSA drop of 31.5% during the first 12 months after treatment predicted a recurrence with a sensitivity of 53.8% and a specificity of 79.2%. A PSA drop of 55.3% 12 months after treatment predicted a recurrence with a sensitivity of 91.7% and a specificity of 51.9%. FTC for primary localized PCa seems to be associated with a low but not negligible percentage of recurrences. Serum PSA levels may have a role indicating RR.
ABSTRACT
CONTEXT: Prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) is a novel imaging technique with several potential applications in the prostate cancer (PCa) setting. OBJECTIVE: To perform a systematic review of the current evidence regarding the diagnostic performance of PSMA PET/MRI in patients with primary and recurrent PCa. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the MEDLINE and Cochrane Library databases was performed in October 2020. The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Studies were deemed eligible if they assessed patients with primary or recurrent PCa (P) undergoing PSMA PET/MRI (I) with or without comparison with other imaging techniques (C) in order to evaluate its diagnostic performance (O). Retrospective and prospective primary clinical studies were included. Results of previous meta-analyses were reported. EVIDENCE SYNTHESIS: A total of 23 original articles and three meta-analyses were included. Limited evidence on PSMA PET/MRI is available, especially in the setting of partial gland ablation. PET/MRI can be an effective imaging modality for detecting primary PCa, showing higher accuracy than multiparametric MRI alone. It provides accurate local staging of primary PCa; however, there are contradictory results in this context when its performance is compared with other imaging techniques. PET/MRI also shows high performance for restaging and detecting tumor recurrence, even at low prostate-specific antigen levels. CONCLUSIONS: PSMA PET/MRI could represent a valuable tool in the management of patients with primary and recurrent PCa. No specific recommendations can be provided. PATIENT SUMMARY: Encouraging data regarding the benefits of prostate-specific membrane antigen positron emission tomography/magnetic resonance imaging in patients with prostate cancer are emerging from the literature.
Subject(s)
Prostate-Specific Antigen , Prostatic Neoplasms , Humans , Magnetic Resonance Imaging , Male , Neoplasm Recurrence, Local/diagnostic imaging , Positron-Emission Tomography , Prospective Studies , Prostate/pathology , Prostatic Neoplasms/pathology , Retrospective StudiesABSTRACT
The Peyronie's Disease Questionnaire (PDQ) is a 15-question self-reported questionnaire that evaluates the severity and physical and psychosexual issues of Peyronie's disease (PD) symptoms in three scales: "psychological and physical symptoms," "penile pain," and "symptom bother." Previous studies validated the PDQ US version and confirmed its test-retest reliability and responsiveness. The aim is to translate and validate the Spanish version of the PDQ to be used in the clinical practice and in PD research studies in Spain. A non-interventional, observational study with 160 PD patients was conducted. Patients included from four healthcare centers in Spain and completed the PDQ in two study visits separated for a period of 4-7 days from March 2018 to June 2019. Patients received no type of treatment or intervention. Different statistical tests were applied to the data in order to validate the structural and construct of the PDQ, as well as its internal reliability, temporal stability reliability, reliability between observers, and test-retest reliability. Cronbach's alpha over 0.9 showed good internal consistency. We found an ICC agreement of 0.82 (test-retest) for the three scales of the Spanish version of the PDQ, which demonstrates good reliability. When comparing Visit 1 and Visit 2 questionnaires mean scores, the PDQ showed non-significant differences, as expected because no intervention or treatment was administered to the patients between visits. Translation and validation of the PDQ for the Spanish population makes available a valid, useful, and reliable tool to properly evaluate quality of life of men suffering PD.
Subject(s)
Penile Induration , Humans , Male , Penile Induration/drug therapy , Quality of Life , Reproducibility of Results , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Phosphodiesterase type 5 inhibitors (PDE5Is) are the first-line therapeutic option for erectile dysfunction (ED), while second-line therapy includes the alprostadil. Due to the different pharmacodynamic mechanism of PDE5Is and alprostadil, a synergistic action is conceivable when they are administered in combination. The aim of present study was to evaluate the efficacy and safety of combination therapy with PDE5I and topical alprostadil in patients with ED non-responders to PDE5I alone. We designed a prospective, two-arm, open-label, non-randomized study. Patients over 18 years old, with a stable sexual relationship for at least 6 months, and ED non-responders to PDE5I monotherapy were included in the study. At baseline the variables assessed were 5-item version of the International Index of Erectile Function (IIEF-5), and Sexual Encounter Profile Questions 2 and 3 (SEP-2 and SEP-3). In addition, all subjects underwent penile dynamic duplex ultrasonography. All patients were assigned to the monotherapy group (Group A) or combination therapy group (Group B) based on their preference. Topical alprostadil 300 µg/100 mg (Virirec®) was the treatment assigned to Group A, while the combination therapy with the last PDE5I taken (at the maximum recommended dose) plus topical alprostadil 300 µg/100 mg (Virirec®) was assigned to Group B. After 3 months from assignment to groups were evaluated IIEF-5, SEP-2 and SEP-3 regarding the last sexual intercourse, and Global Assessment Questionnaire-Questions 1 and 2 (GAQ-1 and GAQ-2). All adverse events (AEs) that occurred during the study period were recorded. A total of 170 patients were included in the study (72 in Group A and 98 in Group B). Fifty-two patients were previously treated with sildenafil 100 mg (30.6%), 6 with vardenafil 20 mg (3.5%), 56 with tadalafil 20 mg (32.9%), and 56 with avanafil 200 mg (32.9%). No significant differences among the study groups were found at baseline (p > 0.05). The mean IIEF-5 score increased significantly in Group B after treatment compared to baseline (12.4 ± 3.4 vs. 17.1 ± 4.5; p < 0.001), conversely patients in Group A showed no significant increase (12.2 ± 2.5 vs. 12.7 ± 3.1; p = 0.148). The number of affirmative responses to SEP-2 was significantly higher after treatment compared to baseline only in Group B (57 vs. 78; p < 0.001). The number of affirmative responses to SEP-3 was significantly higher after treatment compared to baseline in both groups (p < 0.001). The number of affirmative responses to GAQ-Q1 and GAQ-Q2 was significantly higher in Group B compared to Group A (p < 0.001). A total of 59 (34.7%) patients experienced AEs. They were mild, self-limited, and did not cause discontinuation of treatment. No episode of priapism was recorded. No statistically significant difference was recorded between the AEs of the two groups, except for facial flushing that was reported only in Group B (p = 0.021). The combination therapy with topical alprostadil and PDE5I seems to be more effective than topical alprostadil alone without worsening the safety of the treatment.
Subject(s)
Alprostadil , Erectile Dysfunction , Phosphodiesterase 5 Inhibitors , Administration, Topical , Adult , Alprostadil/administration & dosage , Double-Blind Method , Drug Therapy, Combination/adverse effects , Erectile Dysfunction/drug therapy , Humans , Male , Phosphodiesterase 5 Inhibitors/administration & dosage , Prospective Studies , Treatment FailureABSTRACT
Imaging has a central role in the context of focal therapy (FT) for prostate cancer (PCa). Prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) is a novel imaging modality that combines the morpho-functional information of MRI with the molecular characterization of PET. Some papers reported the potential advantages of PSMA PET/MRI in different clinical scenarios. Limited evidence on PSMA PET/MRI is available in the setting of FT. PSMA PET/MRI can be an effective imaging modality for detecting primary PCa and seems to provide accurate local staging of primary PCa. PSMA PET/MRI also shows high performance for restaging and detecting tumor recurrence. The higher soft-tissue contrast and the reduction of ionizing radiation are the main advantages reported in the literature compared to PET/computed tomography. PSMA PET/MRI could represent a turning point in the management of patients with PCa in the context of FT. Further studies are needed to confirm its applications in this specific clinical setting.
ABSTRACT
In the present study we aimed to investigate the surgical outcomes of patients with persistent penile curvature (PC) after Collagenase Clostridium histolyticum (CCH) intraplaque injections. Data from 90 patients with persistent PC after CCH in a multicentre study from 6 andrological centres were retrospectively reviewed. Three standardized surgical techniques were performed. Group 1: plaque incision grafting (PIG) with penile prosthesis implant (PPI); Group 2: PIG without PPI; Group 3: Nesbit technique. Hospital stay, operative time, postoperative complications and PC persistency/recurrence (> 20°) were evaluated. Overall satisfaction and functional outcomes were assessed through International Index of Erectile Function-Erectile Function (IIEF-EF), Peyronie's Disease Questionnaire (PDQ), Female Sexual Function Index (FSFI) administered pre and 3 months postoperatively. Of all, 25 (27.8%) patients received grafting procedure + PPI (Group 1), 18 (20.0%) patients belonged to Group 2, and 47 (52.2%) to Group 3. Bovine pericardium graft and collagen fleece have been used in in 22 (51.2%) and 21 (48.8%) patients, respectively. Median penile length after surgery was 13.0 cm (IQR 12.0-15.0). After surgery, Group 1 showed higher increase in penile length after surgery and better improvements in terms of PDQ-PS. In contrast, both IIEF-EF and FSFI scores did not differ among groups. Overall, 86 (95.6%) did not report any complication. 4 (4.4%) patients had PC recurrence; of those, 2 (8.0%), 1 (5.6%) and 1 (2.1%) cases were observed in Group 1, Group 2 and Group 3, respectively. In case of persistent PC after CCH, surgical correction by grafting with or without concomitant PPI or Nesbit technique emerged as a technically feasible, effective and safe procedure, with no significant postoperative complications.
Subject(s)
Clostridium histolyticum/metabolism , Microbial Collagenase/pharmacology , Penile Induration/surgery , Adult , Humans , Injections, Intralesional , Male , Middle Aged , Patient Satisfaction , Penile Implantation , Postoperative Period , Retrospective Studies , Surveys and Questionnaires , Treatment OutcomeABSTRACT
BACKGROUND AND OBJECTIVE: Plaque formation ordinarily takes place in the acute phase of Peyronie's disease. There is no unanimous consent regarding the management of the acute phase of Peyronie's disease. The objective of this study was to evaluate the advantages of using a single intralesional injection of collagenase Clostridium histolyticum in patients with the active phase of Peyronie's disease and to assess its effect on disease progression by reducing penile curvature and ameliorating pain during sexual intercourse. METHODS: Sexually active men aged older than 18 years with the acute phase of Peyronie's disease were enrolled. All patients received treatment with a single intralesional injection of collagenase Clostridium histolyticum. The primary outcome of the study was the change in penile curvature after treatment while secondary outcomes were the change in sexual function (International Index of Erectile Function [IIEF-5]) and in the Peyronie Disease Questionnaire (PDQ) and its sub-scores, PDQ-PS (psychological symptoms), PDQ-PP (penile pain) and PDQ-BD (bother disease). RESULTS: Overall, 74 patients were enrolled. Mean penile curvature at baseline was 41.1° ± 12.2°. The mean changes before and at the 3-month evaluation in terms of penile curvature, Visual Analog Scale score at rest, and Visual Analog Scale score during intercourse were - 19.3 ± 8.4 (p < 0.0001), - 0.8 ± 1.1 (p < 0.0001) and - 3.8 ± 0.9 (p < 0.0001) with the benefit persisting also after 6 months. Moreover, improvements of mean IIEF-5 score (1.1 ± 0.9, p = 0.03; 0.9 ± 0.5, p = 0.02), PDQ-PS (- 2.7 ± 2.2; - 2.5 ± 2.0, p = 0.01), PDQ-PP (- 1.2 ± 1.6; - 1.1 ± 1.2, p = 0.02) and PDQ-BD (- 3.8 ± 3.4; - 3.5 ± 3.1, p = 0.001) were observed 3 and 6 months after the end of treatment, respectively. At the multivariable regression analysis, the time since disease onset (modelled with non-linear terms) and baseline curvature were independently associated with the degree of curvature improvement (coefficient: 0.30; 95% confidence interval 0.16-0.44) after a single intralesional injection (all p < 0.03). CONCLUSIONS: Although intralesional therapy with collagenase Clostridium histolyticum is not yet indicated for the acute phase of Peyronie's disease, these preliminary results suggest the effectiveness of this minimally invasive option by improving penile curvature and IIEF-5 and PDQ scores.
Subject(s)
Clostridium histolyticum/enzymology , Collagenases/therapeutic use , Penile Induration/drug therapy , Acute Disease , Adolescent , Adult , Aged , Collagenases/administration & dosage , Disease Progression , Humans , Injections, Intralesional , Male , Middle Aged , Pain , Surveys and Questionnaires , Treatment OutcomeABSTRACT
PURPOSE: The COVID-19 pandemic which has affected Spain since the beginning of 2020 compels us to determine recomendations for the practice of Andrology in present times. MATERIALS AND METHODS: A web search is carried out in English and Spanish and a joint proposal is defined by experts in Andrology from different regions of Spain. RESULTS: Most diagnostic and therapeutic procedures in Andrology can be safey postponed during the COVID-19 pandemic. Online consultations and outpatient surgeries must be encouraged. Andrologic emergencies and penile cancer management should be considered high priority, and should be diagnosed and treated promptly even in the most severe phases of the pandemic.
INTRODUCCIÓN: La pandemia COVID-19 que ha afectado a España desde comienzos de 2020 obliga a definir unas recomendaciones para la práctica de la Andrología en la actualidad.MATERIAL Y MÉTODOS: Se realiza una búsqueda web en inglés y español y se define una propuesta conjunta por parte de expertos en Andrología de distintas regiones de España.RESULTADOS: La mayor parte de los procedimientos diagnósticos y terapéuticos en Andrología pueden ser demorados con seguridad durante la pandemia COVID-19. Se debe fomentar la consulta telemática y la cirugía ambulatoria. Las urgencias andrológicas y el manejo del cáncer de pene deben considerarse una prioridad alta, diagnosticándose y tratándose con brevedadi ncluso en las fases más severas de la pandemia.
Subject(s)
Coronavirus Infections , Pandemics , Penile Neoplasms , Pneumonia, Viral , Andrology , Betacoronavirus , COVID-19 , Coronavirus Infections/epidemiology , Humans , Male , Penile Neoplasms/diagnosis , Penile Neoplasms/therapy , Pneumonia, Viral/epidemiology , SARS-CoV-2 , SpainABSTRACT
The arrival of Pfizer's blue pill Sildenafil in 1998 brought a great relief both to patient and physician signalling the start of a great era of medical therapy in sexual medicine. Since then the sexual medicine experts have been prescribing sildenafil in erectile dysfunction with acceptable minor adverse events. But the use of sildenafil in premature ejaculation (PE) is still debated. 2018 being the 20th anniversary of sildenafil, we have compiled interesting facts about the role of sildenafil in PE from various original articles, systematic reviews, meta-analyses, economic brochures and sexual medicine committee guidelines. The major issues in most of these studies were the heterogeneity in the definition of PE and estimating the exact ejaculatory latency time. This perspective article highlights the positive role of sildenafil in the management of PE (even without ED) with acceptable adverse events. Now that we have a standardised definition of PE from International Society of Sexual Medicine (ISSM) and a psychogenic component in PE definition, more randomised placebo-controlled studies are required to further establish its role.