Publications by authors named "Ioannis Sokolakis"

52 Publications

Consensus and Diversity in the Management of Varicocele for Male Infertility: Results of a Global Practice Survey and Comparison with Guidelines and Recommendations.

World J Mens Health 2022 Jun 13. Epub 2022 Jun 13.

Department of Urology, Bolu Abant Izzet Baysal University, Bolu, Turkey.

Purpose: Varicocele is a common problem among infertile men. Varicocele repair (VR) is frequently performed to improve semen parameters and the chances of pregnancy. However, there is a lack of consensus about the diagnosis, indications for VR and its outcomes. The aim of this study was to explore global practice patterns on the management of varicocele in the context of male infertility.

Materials And Methods: Sixty practicing urologists/andrologists from 23 countries contributed 382 multiple-choice-questions pertaining to varicocele management. These were condensed into an online questionnaire that was forwarded to clinicians involved in male infertility management through direct invitation. The results were analyzed for disagreement and agreement in practice patterns and, compared with the latest guidelines of international professional societies (American Urological Association [AUA], American Society for Reproductive Medicine [ASRM], and European Association of Urology [EAU]), and with evidence emerging from recent systematic reviews and meta-analyses. Additionally, an expert opinion on each topic was provided based on the consensus of 16 experts in the field.

Results: The questionnaire was answered by 574 clinicians from 59 countries. The majority of respondents were urologists/uro-andrologists. A wide diversity of opinion was seen in every aspect of varicocele diagnosis, indications for repair, choice of technique, management of sub-clinical varicocele and the role of VR in azoospermia. A significant proportion of the responses were at odds with the recommendations of AUA, ASRM, and EAU. A large number of clinical situations were identified where no guidelines are available.

Conclusions: This study is the largest global survey performed to date on the clinical management of varicocele for male infertility. It demonstrates: 1) a wide disagreement in the approach to varicocele management, 2) large gaps in the clinical practice guidelines from professional societies, and 3) the need for further studies on several aspects of varicocele management in infertile men.
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http://dx.doi.org/10.5534/wjmh.220048DOI Listing
June 2022

Correction: The relationship between the gut microbiota, benign prostatic hyperplasia, and erectile dysfunction.

Int J Impot Res 2022 Jul 5. Epub 2022 Jul 5.

Urology Unit, Department of Medicine, Surgery, Dentistry "Scuola Medica Salernitana", University of Salerno, Baronissi, Italy.

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http://dx.doi.org/10.1038/s41443-022-00594-0DOI Listing
July 2022

The relationship between the gut microbiota, benign prostatic hyperplasia, and erectile dysfunction.

Int J Impot Res 2022 Apr 13. Epub 2022 Apr 13.

Urology Unit, Department of Medicine, Surgery, Dentistry "Scuola Medica Salernitana", University of Salerno, Baronissi, Italy.

Microbiota is defined as the group of commensal microorganisms that inhabit a specific human body site. The composition of each individual's gastrointestinal microbiota is influenced by several factors such as age, diet, lifestyle, and drug intake, but an increasing number of studies have shown that the differences between a healthy microbiota and a dysbiotic one can be related to different diseases such as benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). The aim of this review is to give an overview of the role of the gut microbiota on BPH and ED. Gut microbiota modifications can influence prostate health indirectly by the activation of the immune system and the production of proinflammatory cytokines such as IL-17, IL-23, TNF-alpha, and IFN-gamma, which are able to promote an inflammatory state. Gut dysbiosis may lead to the onset of ED by the alteration of hormone levels and metabolic profiles, the modulation of stress/anxiety-mediated sexual dysfunction, the development of altered metabolic conditions such as obesity and diabetes mellitus, and the development of hypertension. In conclusion, much evidence suggests that the intestinal microbiota has an influence on various pathologies including BPH and ED.
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http://dx.doi.org/10.1038/s41443-022-00569-1DOI Listing
April 2022

Preserving Ejaculation: A Guide Through the Landscape of Interventional and Surgical Options for Benign Prostatic Obstruction.

Eur Urol Focus 2022 Mar 24;8(2):380-383. Epub 2022 Mar 24.

Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany.

Surgical treatment for benign prostatic obstruction in patients wishing to preserve normal ejaculation remains a urological challenge. Standard surgical techniques are associated with high rates of postoperative ejaculatory dysfunction. Research is now concentrating on ejaculation-preserving modifications of standard surgical techniques and on alternative minimally invasive interventional techniques. Ejaculation-preserving modifications seem to be superior to standard techniques for preservation of ejaculation with comparable efficacy in terms of improvement in lower urinary tract symptoms (LUTS). Among the alternative minimally invasive interventional techniques, prostatic artery embolization and prostatic urethral lift provide high success rates for patients wishing to preserve ejaculation but are inferior to standard surgical techniques regarding improvement in LUTS. High-quality studies focusing on ejaculatory function as the primary outcome are still lacking. PATIENT SUMMARY: Benign prostate enlargement can cause obstruction of the lower urinary tract. We reviewed the evidence for techniques that preserve ejaculatory function in treatment of this condition. These ejaculation-preserving treatment techniques may have lower efficacy in improving bothersome urinary symptoms.
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http://dx.doi.org/10.1016/j.euf.2022.03.008DOI Listing
March 2022

COVID‑19‑related postponement of elective sexual or reproductive health operations deteriorates private and sexual life: an ongoing nightmare study.

Int J Impot Res 2022 Mar 15;34(2):158-163. Epub 2022 Feb 15.

Department of Urology, 'Martha-Maria' Hospital Nuremberg, Nuremberg, Germany.

We aimed to assess the impact of postponing sexual or reproductive health surgeries on patients' psychosocial distress and personal or occupational life during the COVID-19 pandemic. A total of 77 elective sexual or reproductive health surgeries were postponed. Of them, 38 patients are still on the waiting list for an appointment and, despite our efforts, we managed to operate only 39 patients when operation capacity returned to a normal level. At the time of surgery, all patients were requested to complete a 14-item questionnaire, assessing patients' perception of the COVID-19 pandemic. Patients marked the necessity of operation at the time of initial postponement as urgent and as highly urgent at the time of surgery. Due to the postponement of surgery, they reported experiencing severe restrictions in private life and more concerns and worries for their disease. Interestingly, patients who could not perform sexual intercourse due to the underlying disease wanted to receive surgery more urgently (p = 0.001) and displayed more restrictions in private life (p = 0.007). On the contrary, the duration of surgery postponement was not associated with worse outcomes. Overall, postponement of surgery poses a huge psychological burden that leads to further personal restrictions. Patients that cannot perform sexual intercourse should be prioritized for treatment.
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http://dx.doi.org/10.1038/s41443-022-00538-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8853267PMC
March 2022

Tip of the iceberg: erectile dysfunction and COVID-19.

Int J Impot Res 2022 Mar 12;34(2):152-157. Epub 2022 Feb 12.

Department of Urology, Selcuk University School of Medicine, Konya, Turkey.

The novel severe acute respiratory syndrome coronavirus 2 caused the coronavirus 2019 (COVID-19) pandemic that resulted in more than 150 million infections and 3.5 million deaths globally. COVID-19 affected men more than women, emerging with more severe disease and higher mortality rates. Androgens may be responsible for the underlying reason of more severe disease, as androgen receptors have been implicated to mediate viral cell entry and infection. Besides, male reproductive organs have been reported to be affected by the especially severe disease, resulting in erectile dysfunction (ED). In this narrative review, we aimed to gather possible mechanisms of the development of ED led by COVID-19. Current evidence illuminates endothelial dysfunction, direct testicular damage, and the psychological burden of COVID-19 that are of the pathways of ED. Although the proposed underlying mechanisms partly fail to answer the questions by which COVID-19 leads to ED, it is important to monitor men who recovered from COVID-19 regarding the sexual dysfunction sequelae of infection and address the long-term consequences.
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http://dx.doi.org/10.1038/s41443-022-00540-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8853253PMC
March 2022

Assessment of Conservative Combination Therapies for Active and Stable Peyronie's Disease: A Systematic Review and Meta-analysis.

Eur Urol Focus 2021 Dec 17. Epub 2021 Dec 17.

Department of Urology, 'Martha-Maria' Hospital Nuremberg, Nuremberg, Germany. Electronic address:

Context: In patients with Peyronie's disease (PD), oral, injected, or topical agents provide limited efficacy. In this setting, combination of two or more conservative treatments may improve symptoms further.

Objective: To explore the effects of available conservative combination therapies for active and stable PD through a systematic review and meta-analysis.

Evidence Acquisition: We searched multiple databases and sources of gray literature until June 2021. We included randomized or observational comparative studies assessing any conservative combination therapies for PD. We undertook a random-effect meta-analysis when at least two studies employed the same treatment modality (PROSPERO: CRD42021224517).

Evidence Synthesis: Overall, 13 studies on active PD and ten on stable PD (1962 participants) were included. Most included studies raised methodological concerns. In patients with active or stable PD, the available evidence is inconclusive to support the use of any combination treatment modality, such as intralesional verapamil injections, antioxidants, and other oral, injected, or topical agents. Based on data availability, we performed a meta-analysis to compare the effect of collagenase Clostridium histolyticum (CCH) plus adjunctive mechanical therapies (penile traction or vacuum pump) versus CCH monotherapy on penile curvature and length in patients with stable PD. CCH and adjunctive mechanical therapies resulted in an additional decrease of 0.3° in penile curvature (95% confidence interval [CI]: -3.97 to 4.49, I = 0%) and in an increase of 0.5 cm in penile length (95% CI: -0.32 to 1.4, I = 70%) compared with CCH monotherapy.

Conclusions: The available combination treatment modalities, including the addition of adjunctive mechanical therapies to CCH, do not improve symptoms further compared with monotherapy and should not be implemented in patients with active or stable PD. Further high-quality randomized trials combining only recommended treatments are mandatory.

Patient Summary: Despite the interest in and optimism for combination treatment modalities, the road to an effective conservative therapy for Peyronie's disease still seems long.
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http://dx.doi.org/10.1016/j.euf.2021.12.003DOI Listing
December 2021

[Treatment of advanced hormone-sensitive prostate cancer using degarelix].

Urologe A 2022 Jan 14;61(1):63-67. Epub 2021 Dec 14.

Urologische Klinik, Martha-Maria-Krankenhaus Nürnberg, Stadenstr. 58, 90491, Nürnberg, Deutschland.

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http://dx.doi.org/10.1007/s00120-021-01735-xDOI Listing
January 2022

Relationship between Dietary Patterns with Benign Prostatic Hyperplasia and Erectile Dysfunction: A Collaborative Review.

Nutrients 2021 Nov 19;13(11). Epub 2021 Nov 19.

Urology Section, San Marco Hospital, 95100 Catania, Italy.

Interest in the role of dietary patterns has been consistently emerging in recent years due to much research that has documented the impact of metabolism on erectile dysfunction (ED) and/or benign prostatic hyperplasia (BPH). We conducted a non-systematic review of English articles published from 1964 to September 2021. The search terms were: ("dietary patterns" OR "diet") AND/OR ("erectile dysfunction") AND/OR ("benign prostatic hyperplasia"). In the present review, we have highlighted how the association between dietary patterns and two of the most frequent pathologies in urology, namely erectile dysfunction and benign prostatic hyperplasia, is present in the literature. The data suggested that a diet that is more adherent to the Mediterranean diet or that emphasizes the presence of vegetables, fruits, nuts, legumes, and fish or other sources of long-chain (n-3) fats, in addition to reduced content of red meat, may have a beneficial role on erectile function. At the same time, the same beneficial effects can be transferred to BPH as a result of the indirect regulatory effects on prostatic growth and smooth muscle tone, thus determining an improvement in symptoms. Certainly, in-depth studies and translational medicine are needed to confirm these encouraging data.
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http://dx.doi.org/10.3390/nu13114148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8618879PMC
November 2021

Redox Balance in Male Infertility: Excellence through Moderation-"Μέτρον ἄριστον".

Antioxidants (Basel) 2021 Sep 27;10(10). Epub 2021 Sep 27.

Department of Urology, "G. Gennimatas" General Hospital, Aristotle University of Thessaloniki, 54635 Thessaloniki, Greece.

Male infertility, a relatively common and multifactorial medical condition, affects approximately 15% of couples globally. Based on WHO estimates, a staggering 190 million people struggle with this health condition, and male factor is the sole or contributing factor in roughly 20-50% of these cases. Nowadays, urologists are confronted with a wide spectrum of conditions ranging from the typical infertile male to more complex cases of either unexplained or idiopathic male infertility, requiring a specific patient-tailored diagnostic approach and management. Strikingly enough, no identifiable cause in routine workup can be found in 30% to 50% of infertile males. The medical term male oxidative stress infertility (MOSI) was recently coined to describe infertile men with abnormal sperm parameters and oxidative stress (OS), including those previously classified as having idiopathic infertility. OS is a critical component of male infertility, entailing an imbalance between reactive oxygen species (ROS) and antioxidants. ROS abundance has been implicated in sperm abnormalities, while the exact impact on fertilization and pregnancy has long been a subject of considerable debate. In an attempt to counteract the deleterious effects of OS, urologists resorted to antioxidant supplementation. Mounting evidence indicates that indiscriminate consumption of antioxidants has led in some cases to sperm cell damage through a reductive-stress-induced state. The "antioxidant paradox", one of the biggest andrological challenges, remains a lurking danger that needs to be carefully avoided and thoroughly investigated. For that reason, oxidation-reduction potential (ORP) emerged as a viable ancillary tool to basic semen analysis, measuring the overall balance between oxidants and antioxidants (reductants). A novel biomarker, the Male infertility Oxidative System (MiOXSYS), is a paradigm shift towards that goal, offering a quantification of OS via a quick, reliable, and reproducible measurement of the ORP. Moderation or "" according to the ancient Greeks is the key to successfully safeguarding redox balance, with MiOXSYS earnestly claiming its position as a guarantor of homeostasis in the intracellular redox milieu. In the present paper, we aim to offer a narrative summary of evidence relevant to redox regulation in male reproduction, analyze the impact of OS and reductive stress on sperm function, and shed light on the "antioxidant paradox" phenomenon. Finally, we examine the most up-to-date scientific literature regarding ORP and its measurement by the recently developed MiOXSYS assay.
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http://dx.doi.org/10.3390/antiox10101534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533291PMC
September 2021

Reply by Authors.

J Urol 2021 11 16;206(5):1282. Epub 2021 Aug 16.

Department of Urology, Goldstadt Clinic, Pforzheim, Germany.

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http://dx.doi.org/10.1097/JU.0000000000001933.02DOI Listing
November 2021

The Effect of Antioxidant Supplementation on Operated or Non-Operated Varicocele-Associated Infertility: A Systematic Review and Meta-Analysis.

Antioxidants (Basel) 2021 Jul 1;10(7). Epub 2021 Jul 1.

Urology Department, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.

In patients with varicocele-associated infertility, the effect of antioxidant supplementation on fertility is unknown. We performed a systematic review and meta-analysis to explore their role in patients with operated or non-operated varicocele. We searched major databases and sources of grey literature until May 2021 (PROSPERO: CRD42021248195). We included 14 studies (980 individuals) in the systematic review. Of the 14 studies, 2 explored the effect of antioxidant supplementation in patients with non-operated varicocele, 1 compared antioxidants versus surgical repair of varicocele, while 11 explored antioxidants after surgical repair of varicocele and were also included in the meta-analysis. Regarding pregnancy rates, no significant differences were demonstrated after treatment with antioxidants versus no treatment at three (OR: 2.28, 95% CI: 0.7-7.48) and six months (OR: 1.88, 95% CI: 0.62-5.72). Accordingly, contradictory findings were reported in sperm concentration, morphology, and motility, as well as DNA fragmentation. Our findings indicate that antioxidant supplementation does not improve pregnancy rates and semen parameters in patients with varicocele-associated infertility, in the absence of previous screening for oxidative stress. Based on the previous notion, most included studies also raised methodological concerns. Therefore, definitive conclusions about the efficacy of antioxidant supplementation in this setting cannot be drawn and further research on the field is mandatory.
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http://dx.doi.org/10.3390/antiox10071067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8301171PMC
July 2021

Amyloidosis of the Urinary Bladder: A Systematic Review and a Proposed Management Algorithm.

Urology 2021 Oct 25;156:e12-e19. Epub 2021 Jul 25.

School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece; Urology Department, The Pennine Acute Hospitals NHS Trust, Manchester, UK.

Objective: To propose an algorithm for the management of bladder amyloidosis based on a systematic review of the literature, given that the bladder is the second most commonly affected organ of the urinary tract in the course of systemic or localized amyloidosis.

Methods: We searched PubMed, Cochrane Library and Scopus databases utilizing PRISMA methodology from inception to November 30, 2020 (PROSPERO: CRD42020207855).

Results: We included 76 studies with 184 patients (9 case series and 67 case reports). Presenting symptoms of bladder amyloidosis comprised of hematuria, irritative or obstructive urinary symptoms, and cystitis-like symptoms. The diagnosis of amyloidosis was established by histologic examination of specimens retrieved during transurethral resection of bladder lesions. Complete endoscopic resection, the cornerstone of management of localized disease, was feasible in 89.1% cases. The included patients were followed up for a mean of 54 months, within which 65 patients (35.3%) recurred. The time to first amyloidosis recurrence was 20 months (range: 1-168). Additionally, 16 individuals presented with concomitant bladder amyloidosis and bladder cancer, while 4 developed bladder malignancy during follow-up. Due to the frequent and early recurrences of patients with bladder amyloidosis, a check-up cystoscopy at 3, 12, and 24 months' after initial resection is recommended. Recurrences should be managed with transurethral resection, while intravesical instillations of dimethyl sulfoxide (DMSO) and cystectomy should be reserved for refractory cases.

Conclusion: We propose a management algorithm for bladder amyloidosis based on the available evidence for this rare benign entity that mimics bladder cancer.
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http://dx.doi.org/10.1016/j.urology.2021.07.013DOI Listing
October 2021

A comprehensive narrative review of residual curvature correction during penile prosthesis implantation in patients with severe erectile dysfunction and concomitant Peyronie's disease.

Transl Androl Urol 2021 Jun;10(6):2669-2681

Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany.

Residual curvature correction during penile prosthesis implantation (PPI) is usually needed in patients with severe erectile dysfunction (ED) and concomitant Peyronie's disease (PD). The aim of the study was to assess the different existing techniques for treating residual penile curvature during PPI in patients with severe PD and ED. We generated a comprehensive narrative review of the literature until August 2020 on the use of PPI in combination with straightening reconstruction techniques, in treating patients with severe PD and ED. We included studies published in English, assessing the PPI as primary intervention in patients with PD and ED. Secondary research studies and studies with insufficient data were excluded from final analyses. We included a total of 33 clinical articles with 1,612 patients that assessed the effects of PPI combined with straightening surgical techniques for the treatment of severe PD and ED. Based on the severity of penile curvature, the concomitance of additional penile deformities (i.e., hourglass deformity), the penile length, the presence of previous penile operations and the surgeon's experience, four main categories of surgical techniques were identified: (I) PPI with plication of the penis on the convex side of the curvature, (II) transcorporeal plaque incision/excision, (III) PPI with plaque/tunical incision(s) on the concave side of the curvature and (IV) PPI with plaque incision/excision plus grafting. Patients with severe PD and ED can expect excellent outcomes with PPI and surgical correction of residual penile curvature and minimal side effects. Overall, all the above techniques seem to able to correct the residual penile curvature during prosthesis implantation. Grafting techniques seem to be favorable in patients with additional severe penile shortening. Still, no definite conclusions can be drawn regarding the superiority of one technique over the other.
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http://dx.doi.org/10.21037/tau-20-1236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261415PMC
June 2021

Suture-Free Sealing of Tunical Defect with Collagen Fleece after Partial Plaque Excision in 319 Consecutive Patients with Peyronie's Disease: The Sealing Technique.

J Urol 2021 Nov 6;206(5):1276-1282. Epub 2021 Jul 6.

Department of Urology, Goldstadt Clinic, Pforzheim, Germany.

Purpose: We describe the sealing technique with collagen fleece in patients with advanced Peyronie's disease (PD) and provide the prospective long-term outcomes.

Materials And Methods: We performed a multicenter cohort study in patients with preserved erectile function and stable PD that precluded sexual intercourse. All patients underwent partial plaque excision with collagen fleece grafting. The applied technique is explained through a high-quality video accompanied by relevant animations. After hospital discharge, all patients were assessed at 1, 4 and 24 weeks after treatment. Subsequently, they presented for an additional long-term evaluation.

Results: From December 2004 to June 2015, 367 patients underwent surgery. Of these, 319 (86.9%) presented for the long-term evaluation and were included in the present study. At a median operative time of 79.8 minutes (range 50-130), total straightness of the penis was achieved in 299 cases (93.7%) and mean±SD penile length increased by 1.1±0.6 cm (p=0.017). After a median followup of 47.2 months (range 12-100), 291 patients (91.2%) presented with complete penile straightness. The penile glans sensation returned to the preoperative levels in 300 cases (94%). Only 11 cases of treatment-related grade 1 Clavien-Dindo complications were reported. Erectile function improved in 78 participants (24.5%) and remained unchanged in 191 (59.8%), whereas it was worsened in 50 (15.7%). Overall, the patient satisfaction rate was 87.8% and the partner satisfaction rate was 84.3%.

Conclusions: Grafting with collagen fleece in patients with advanced PD is a safe and effective procedure that reduces operative time, provides an additional hemostatic effect and represents a cost-effective technique.
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http://dx.doi.org/10.1097/JU.0000000000001933DOI Listing
November 2021

Penile Prosthesis Implantation Combined With Grafting Techniques in Patients With Peyronie's Disease and Erectile Dysfunction: A Systematic Review.

Sex Med Rev 2022 07 1;10(3):451-459. Epub 2021 Jul 1.

Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany. Electronic address:

Introduction: Penile prosthesis (PP) implantation combined with grafting techniques is indicated in patients with Peyronie's disease (PD) and erectile dysfunction (ED) nonresponsive to medical and conservative treatment that present with residual penile curvature greater than 30°, severe penile deformity or significant penile shortening.

Objectives: To address the preoperative evaluation, the surgical procedure and the functional outcomes of grafting techniques combined with PP implantation in patients with PD and concomitant ED and to provide future perspectives on the matter.

Methods: We performed a systematic review of the literature based on the PRISMA statement (PROSPERO ID: CRD42021224517). Records were identified by searching Medline, Scopus, The Cochrane Library and Web of Science databases as well as sources of gray literature from inception to December 2020. The quality of all included records was assessed based on a modified version of the Newcastle-Ottawa Scale for cohort studies.

Results: A total of 935 patients with a mean age of 59.6 ± 9.2 years from 23 studies were included in this systematic review. All studies reported excellent short- and long-term postoperative results, as well as high satisfaction rates ranging from 80 to 100%. A mean increase of 2.7 ± 1.4 cm in penile length was observed. Among different grafting materials and different types of PP, no significant differences in terms of preoperative, perioperative and postoperative functional outcomes or complications were demonstrated. Still, the operative time was shorter in studies applying the collagen fleece TachoSil.

Conclusions: PP implantation combined with grafting is a safe and highly effective surgical procedure in patients with PD and concomitant ED. All grafting materials provide similar beneficial outcomes, but TachoSil subsequently reduces the operative time and does not require suturing. Still, no definite conclusions can be drawn regarding the superiority of one grafting technique over the other, as randomized clinical trials are lacking. Sokolakis I, Pyrgidis N, Ziegelmann M, et al. Penile Prosthesis Implantation Combined With Grafting Techniques in Patients With Peyronie's Disease and Erectile Dysfunction: A Systematic Review. Sex Med Rev 2022;10:444-452.
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http://dx.doi.org/10.1016/j.sxmr.2021.03.007DOI Listing
July 2022

Usability and diagnostic accuracy of different MRI/ultrasound-guided fusion biopsy systems for the detection of clinically significant and insignificant prostate cancer: a prospective cohort study.

World J Urol 2021 Nov 17;39(11):4101-4108. Epub 2021 Jun 17.

Department of Urology and Pediatric Urology, Julius-Maximilians-University of Würzburg, Würzburg, Germany.

Purpose: To explore the usability and diagnostic accuracy for prostate cancer of three multiparametric magnetic resonance imaging (mpMRI)/transrectal ultrasound (TRUS)-guided fusion biopsy systems operated by the same urologists.

Methods: We performed a prospective, observational study including patients that underwent prostate biopsy due to a visible lesion in mpMRI (PI-RADS ≥ 3). We consecutively assessed two platforms with a rigid image registration (BioJet, D&K Technologies and UroNav, Invivo Corporation) and one with an elastic registration (Trinity, KOELIS). Four urologists evaluated each fusion system in terms of usability based on the System Usability Scale and diagnostic accuracy based on the detection of prostate cancer.

Results: We enrolled 60 consecutive patients that received mpMRI/TRUS-guided prostate biopsy with the BioJet (n = 20), UroNav (n = 20) or Trinity (n = 20) fusion system. Comparing the rigid with the elastic registration systems, the rigid registration systems were more user-friendly compared to the elastic registration systems (p = 0.012). Similarly, the prostate biopsy with the rigid registration systems had a shorter duration compared to the elastic registration system (p < 0.001). Overall, 40 cases of prostate cancer were detected. Of them, both the BioJet and UroNav fusion systems detected 13 prostate cancer cases, while the Trinity detected 14. No significant differences were demonstrated among the three fusion biopsy systems in terms of highest ISUP Grade Group (p > 0.99).

Conclusions: Rigid fusion biopsy systems are easier to use and provide shorter operative time compared to elastic systems, while both types of platforms display similar detection rates for prostate cancer. Still, further high-quality, long-term results are mandatory.
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http://dx.doi.org/10.1007/s00345-021-03761-yDOI Listing
November 2021

Low-intensity shockwave therapy in Peyronie's disease: long-term results from a prospective, randomized, sham-controlled trial.

Int J Impot Res 2022 Aug 18;34(5):487-494. Epub 2021 May 18.

Department of Urology, 'Martha-Maria' Hospital Nuremberg, Nuremberg, Germany.

Low-intensity shockwave therapy (LiST) is an effective treatment for pain reduction in patients with Peyronie's disease (PD). We aimed to report the long-term results of a previously published randomized, sham-controlled trial on LiST for PD management. For the initial study, 102 patients with stable PD were randomly assigned to six sessions of LiST (n = 51) or sham (n = 51) therapy. All participants were subsequently contacted for an additional evaluation at 3 years after completion of the initial treatment and 63 of them (LiST = 34 and sham therapy = 29) presented for the evaluation. Among them, improvement of pain was reported in 23 participants (LiST = 16, sham = 7, p = 0.005) at 4 weeks and in 22 (LiST = 15, sham = 7, p = 0.031) at 3 years. We detected a mean difference of 2.2 points (95%CI: 0.9-3.5, p = 0.002) in the visual analog pain scale at 4 weeks and a mean difference of 2.5 points (95%CI: 1-4, p = 0.002) at 3 years between the two groups. No treatment-related complications occurred during the sessions or the follow-up period. Regarding the improvement of penile curvature or sexual function, no significant differences between the two groups were observed. Overall, LiST constitutes a safe and effective therapeutic approach for pain management both in the short- and long term.
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http://dx.doi.org/10.1038/s41443-021-00447-2DOI Listing
August 2022

Frenuloplasty: from alpha to omega.

Int J Impot Res 2022 May 18;34(4):347-352. Epub 2021 May 18.

Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany.

Frenuloplasty is a common surgical procedure performed on an outpatient basis either for the treatment of frenulum breve alone or as an additional intervention in patients undergoing circumcision. We aimed to provide tips and tricks on performing frenuloplasty, either alone or in combination with circumcision, and to generate a comprehensive review of the available literature on the matter. We suggest that the frenulum should be divided with a scalpel without the use of diathermy and reapproximated with interrupted 4-0 absorbable sutures. Moreover, the frenular artery should be maintained and any injury of the glans must be avoided to ensure optimal functional outcomes. After the procedure, a paraffin gauze filled with antibiotic paste followed by a light compression dressing for one day should be placed to maximize cosmetic results. Regarding the available literature, several methods of frenuloplasty have been described, varying from simple division of the frenulum to more sophisticated grafting or plasty techniques. Both the use of diathermy and the application of laser, with or without suturing of the released frenulum, seem to provide optimal functional and esthetic results. However, the findings of all available studies were mitigated by the relatively small number of included participants and low response rates. Additionally, comparative data or high-quality, long-term functional and cosmetic results on the matter are lacking. Therefore, until high-level evidence regarding frenuloplasty is available, individual clinical judgment should prevail.
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http://dx.doi.org/10.1038/s41443-021-00446-3DOI Listing
May 2022

The Effect of Low-intensity Shockwave Therapy on Non-neurogenic Lower Urinary Tract Symptoms: A Systematic Review and Meta-analysis of Preclinical and Clinical Studies.

Eur Urol Focus 2021 May 10. Epub 2021 May 10.

Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany. Electronic address:

Context: Low-intensity shockwave therapy (LiST) has emerged as an effective treatment for pain in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), and it has been postulated that LiST may also be effective in patients with lower urinary tract symptoms (LUTS).

Objective: To perform a systematic review and meta-analysis of experimental and clinical studies exploring the effect of LiST on LUTS in an attempt to provide clinical implications for future research.

Evidence Acquisition: We systematically searched PubMed, Cochrane Library, and Scopus databases from inception to March 2021 for relevant studies. We provided a qualitative synthesis regarding the role of LiST in LUTS and performed a single-arm, random-effect meta-analysis to assess the absolute effect of LiST on LUTS only in patients with CP/CPPS (PROSPERO: CRD42021238281).

Evidence Synthesis: We included 23 studies (11 experimental studies, seven nonrandomized controlled trials [non-RCTs], and five RCTs) in the systematic review and seven in the meta-analysis. All experimental studies were performed on rats with LUTS, and the clinical studies recruited a total of 539 participants. In patients with CP/CPPS, the absolute effect of LiST on maximum flow rate and postvoid residual was clinically insignificant. However, the available studies suggest that LiST is effective for the management of pain in patients with either CP/CPPS or interstitial cystitis/bladder pain syndrome. Additionally, LiST after intravesical instillation of botulinum neurotoxin type A may enhance its absorption and substitute botulinum neurotoxin type A injections in patients with overactive bladder. Furthermore, the available evidence is inconclusive about the role of LiST in patients with benign prostatic obstruction, stress urinary incontinence, or underactive bladder/detrusor hypoactivity.

Conclusions: LiST may be effective for some disorders causing LUTS. Still, further studies on the matter are necessary, since the available evidence is scarce.

Patient Summary: Low-intensity shockwave therapy represents a safe, easily applied, indolent, and repeatable on an outpatient basis treatment modality that may improve lower urinary tract symptoms.
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http://dx.doi.org/10.1016/j.euf.2021.04.021DOI Listing
May 2021

Defining Voiding Dysfunction in Women: Bladder Outflow Obstruction Versus Detrusor Underactivity.

Int Neurourol J 2021 Sep 6;25(3):244-251. Epub 2021 May 6.

2nd Department of Urology of Aristotle University of Thessaloniki, "Papageorgiou" General Hospital of Thessaloniki, Thessaloniki, Greece.

Purpose: We aimed to develop urodynamic criteria to improve the accuracy of the diagnosis of bladder outlet obstruction (BOO) and detrusor underactivity (DU) in women with lower urinary tract symptoms (LUTS).

Methods: Initially, in a group of 68 consecutive women with LUTS and increased postvoid residual (PVR) who had undergone urodynamic investigations, we examined the level of agreement between the operating physician's diagnosis of BOO or DU and the diagnosis according to urodynamic nomograms/indices, including the Blaivas-Groutz (B-G) nomogram, urethral resistance factor (URA), bladder outlet obstruction index (BOOI), and bladder contractility index (BCI). Based on the initial results, we categorized 160 women into 4 groups using the B-G nomogram and URA (group 1, severe-moderate BOO; group 2, mild BOO and URA≥20; group 3, mild BOO and URA<20; group 4, nonobstructed) and compared the urodynamic parameters. Finally, we redefined women as obstructed (groups 1+2) and nonobstructed (groups 3+4) for subanalysis.

Results: The agreement between the B-G nomogram and physician's diagnosis was poor in the mild obstruction zone (κ=0.308, P=0.01). By adding URA (cutoff value=20), excellent agreement was reached (κ=0.856, P<0.001). Statistically significant differences were found among the 4 groups (analysis of variance) in maximum flow rate (Qmax) (P<0.0001), voided volume (VV) (P=0.042), PVR (P=0.032), BOOI (P<0.0001), and BCI (P<0.0001), with a positive linear trend for Qmax and VV and a negative linear trend for PVR and BOOI moving from groups 1 to 4. In the subanalysis, all parameters showed statistically significant differences between obstructed and nonobstructed women, except BCI (Qmax, P=0.0001; VV, P=0.0091; PVR, P=0.0005; BOOI, P=0.0001).

Conclusion: The combination of the B-G nomogram with URA increased the accuracy of diagnosing BOO among women with LUTS. Based on this combination, most women in the mild obstruction zone of the B-G nomogram would be considered underactive rather than obstructed.
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http://dx.doi.org/10.5213/inj.2040342.171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497729PMC
September 2021

Sexual Dysfunction in Women With End-Stage Renal Disease: A Systematic Review and Meta-Analysis.

J Sex Med 2021 05 23;18(5):936-945. Epub 2021 Apr 23.

Urology Department, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Background: In women with end-stage renal disease (ESRD), female sexual dysfunction (SD) remains underestimated.

Aim: To explore the prevalence, correlates, diagnostic approach and treatment modalities of sexual symptoms in females with ESRD.

Methods: We performed a systematic review and meta-analysis to estimate both the prevalence of SD and the pooled Female Sexual Function Index (FSFI) scores in ESRD females. Similarly, for studies reporting the FSFI score before and after renal transplantation (RT), we estimated the effect of RT on sexual function. Further assessment of heterogeneity was conducted via subgroup and sensitivity analyses, cumulative meta-analysis and univariate meta-regression of important correlates. Records were identified through searching PubMed, Cochrane Library and Scopus databases as well as sources of grey literature until November 2020 (PROSPERO ID: CRD42020215178).

Outcomes: We included 47 studies with 61 patient group entries and 3490 ESRD female individuals (median age: 45.2 years, ΙQR: 40.4-50.6).

Results: The SD prevalence in all females with ESRD was 74% (95%CI: 67%-80%, I = 92%) and the FSFI total score 16.1 points (95%CI: 14.3-17.8, I = 98%). The female SD prevalence was 63% (95%CI: 43%-81%, I = 92%) in renal transplant recipients, 80% (95%CI: 72%-87%, I = 91%) in hemodialysis patients and 67% (95%CI: 46%-84%, I = 90%) in peritoneal dialysis patients. The total FSFI score improved by 7.5 points (95%CI: 3.9-11.1, I = 92%) after RT. Older age and menopause were associated with higher SD prevalence.

Clinical Translation: Female SD is highly prevalent in all ESRD women, but renal transplant recipients reported improved sexual function.

Strengths & Limitations: We provide the first study about SD in females and assessed the role of RT on sexual function. Contrary, none of the included studies evaluated the concomitant presence of distress with SD. The levels of heterogeneity were substantially high for all outcomes and we could not adjust for further correlates, which might have affected our measures.

Conclusions: Sexual symptoms negatively affect the quality of life and warrants appropriate clinical attention, as they are an underdetermined and undertreated clinical entity in females with ESRD. Studies on treatment modalities of female SD in patients with ESRD are mandatory, as currently no relevant studies or clinical recommendations exist. Pyrgidis N, Mykoniatis I, Tishukov M, et al. Sexual Dysfunction in Women With End-Stage Renal Disease: A Systematic Review and Meta-Analysis. Sex Med Rev 2021;18:936-945.
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http://dx.doi.org/10.1016/j.jsxm.2021.02.008DOI Listing
May 2021

The Effect of Low-Intensity Extracorporeal Shockwave Treatment on the Urinary Bladder in an Experimental Diabetic Rat Model.

Int Neurourol J 2021 Mar 6;25(1):34-41. Epub 2021 Mar 6.

Institute for the Study of Urologic Diseases, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Purpose: Preclinical data increasingly support an impact of low-intensity extracorporeal shockwave therapy (Li-ESWT) on the bladder. We investigated the molecular effects of Li-ESWT on the bladder of a streptozotocin-induced diabetic rat model.

Methods: Fifteen 8-week-old male Wistar rats were randomized into 3 groups: a control group (n=5), a group of diabetic rats without treatment (diabetes mellitus [DM], n=5) and a group of diabetic rats treated with Li-ESWT (DM-ESWT, n=5). A single intraperitoneal dose of streptozotocin (60 mg/kg) was used to induce diabetes. Twenty days after diabetes induction, each rat in the DM-ESWT group received 300 shockwaves with an energy flux density of 0.09 mJ/mm2. Sessions were repeated 3 times/week for 2 weeks, followed by a 2-week washout period. Total RNA from bladder tissue was extracted, cDNA was synthesized, and quantitative real-time polymerase chain reaction was performed to analyze the expression pattern of transient receptor potential vanilloid 1 (Trpv1), interleukin-1β (Il1b), and the muscarinic receptors M1, M2, and M3 (Chrm1, Chrm2, and Chrm3).

Results: The expression of Trpv1, Il1b, and Chrm2 genes was significantly different between the 3 groups (P=0.002, P<0.0001, and P=0.011, respectively; 1-way analysis of variance). In the DM group, the expression of all genes was higher than in the control group, but statistical significance was observed only for Trpv1 and Il1b (P=0.002 and P<0.0001, respectively). Li-ESWT significantly reduced the expression of Il1b and Chrm2 (P=0.001 and P=0.011, respectively), whereas a nonsignificant tendency for reduced expression was noted for Trpv1 (P=0.069).

Conclusion: The induction of diabetes was associated with increased expression of genes related to mechanosensation, inflammation/ischemia, and contraction in the rat bladder. Li-ESWT reduced the expression of IL1b, Chrm2, and to a lesser extent Trpv1 toward the control levels, suggesting the therapeutic potential of this treatment modality for diabetic cystopathy.
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http://dx.doi.org/10.5213/inj.2040344.172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022171PMC
March 2021

Assessment of Combination Therapies vs Monotherapy for Erectile Dysfunction: A Systematic Review and Meta-analysis.

JAMA Netw Open 2021 02 1;4(2):e2036337. Epub 2021 Feb 1.

Department of Urology, Faculty of Medicine, Aristotle University of Thessaloniki School of Health Sciences, Thessaloniki, Greece.

Importance: Combining 2 first-line treatments for erectile dysfunction (ED) or initiating other modalities in addition to a first-line therapy may produce beneficial outcomes.

Objective: To assess whether different ED combination therapies were associated with improved outcomes compared with first-line ED monotherapy in various subgroups of patients with ED.

Data Sources: Studies were identified through a systematic search in MEDLINE, Cochrane Library, and Scopus from inception of these databases to October 10, 2020.

Study Selection: Randomized clinical trials or prospective interventional studies of the outcomes of combination therapy vs recommended monotherapy in men with ED were identified. Only comparative human studies, which evaluated the change from baseline of self-reported erectile function using validated questionnaires, that were published in any language were included.

Data Extraction And Synthesis: Data extraction and synthesis were performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.

Main Outcomes And Measures: A meta-analysis was conducted that included randomized clinical trials that compared outcomes of combination therapy with phosphodiesterase type 5 (PDE5) inhibitors plus another agent vs PDE5 inhibitor monotherapy. Separate analyses were performed for the mean International Index of Erectile Function (IIEF) score change from baseline and the number of adverse events (AEs) by different treatment modalities and subgroups of patients.

Results: A total of 44 studies included 3853 men with a mean (SD) age of 55.8 (11.9) years. Combination therapy compared with monotherapy was associated with a mean IIEF score improvement of 1.76 points (95% CI, 1.27-2.24; I2 = 77%; 95% PI, -0.56 to 4.08). Adding daily tadalafil, low-intensity shockwave therapy, vacuum erectile device, folic acid, metformin hydrochloride, or angiotensin-converting enzyme inhibitors was associated with a significant IIEF score improvement, but each measure was based on only 1 study. Specifically, the weighted mean difference (WMD) in IIEF score was 1.70 (95% CI, 0.79-2.61) for the addition of daily tadalafil, 3.50 (95% CI, 0.22-6.78) for the addition of low-intensity shockwave therapy, 8.40 (95% CI, 4.90-11.90) for the addition of a vacuum erectile device, 3.46 (95% CI, 2.16-4.76) for the addition of folic acid, 4.90 (95% CI, 2.82-6.98) for the addition of metformin hydrochloride and 2.07 (95% CI, 1.37-2.77) for the addition of angiotensin-converting enzyme inhibitors. The addition of α-blockers to PDE5 inhibitors was not associated with improvement in IIEF score (WMD, 0.80; 95% CI, -0.06 to 1.65; I2 = 72%). Compared with monotherapy, combination therapy was associated with improved IIEF score in patients with hypogonadism (WMD, 1.61; 95% CI, 0.99-2.23; I2 = 0%), monotherapy-resistant ED (WMD, 4.38; 95% CI, 2.37-6.40; I2 = 52%), or prostatectomy-induced ED (WMD, 5.47; 95% CI, 3.11-7.83; I2 = 53%). The treatment-related AEs did not differ between combination therapy and monotherapy (odds ratio, 1.10; 95% CI, 0.66-1.85; I2 = 78%). Despite multiple subgroup and sensitivity analyses, the levels of heterogeneity remained high.

Conclusions And Relevance: This study found that combination therapy of PDE5 inhibitors and antioxidants was associated with improved ED without increasing the AEs. Treatment with PDE5 inhibitors and daily tadalafil, shockwaves, or a vacuum device was associated with additional improvement, but this result was based on limited data. These findings suggest that combination therapy is safe, associated with improved outcomes, and should be considered as a first-line therapy for refractory, complex, or difficult-to-treat cases of ED.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.36337DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7893498PMC
February 2021

Administration of Antioxidants in Infertile Male: When it may have a Detrimental Effect?

Curr Pharm Des 2021;27(24):2796-2801

Department of Urology, University of Ioannina School of Medicine, Ioannina, Greece.

Background & Objective: Significant advances in the field of male infertility have been witnessed during the last years. Given the well-known detrimental effects of reactive oxygen species (ROS), the administration of antioxidants has emerged as a promising solution for oxidative stress (OS)-induced male infertility. Nevertheless, this perception seems largely oversimplified, and the existing literature fails to recognize a notable superiority of the excessive use of these widely available nutritional compounds. Taking into consideration that several trials have shed light on the so-called "antioxidant paradox" phenomenon, we recognize that over-the-counter consumption of such supplements might be harmful.

Methods: The relevant studies indexed in PubMed, Google Scholar and Scopus databases, published until September 2019 were identified and reported.

Conclusion: In this setting, we acknowledge that there is an urgent need for more elaborate studies in the future that will efficiently elucidate the risks and benefits of antioxidants on semen parameters and their impact on fertility potential.
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http://dx.doi.org/10.2174/1381612827666210204160248DOI Listing
October 2021

[Treatment of Ta and T1 intermediate or high risk bladder cancer with intravesical Bacillus Calmette-Guérin or mitomycin C].

Urologe A 2021 Feb 22;60(2):234-237. Epub 2021 Jan 22.

Urologische Klinik, Martha-Maria-Krankenhaus Nürnberg, Stadenstr. 58, 90491, Nürnberg, Deutschland.

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http://dx.doi.org/10.1007/s00120-021-01443-6DOI Listing
February 2021

The use of collagen fleece (TachoSil) as grafting material in the surgical treatment of Peyronie's disease. A comprehensive narrative review.

Int J Impot Res 2022 Apr 15;34(3):260-268. Epub 2021 Jan 15.

Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany.

Grafting for the treatment of Peyronie's disease (PD) can be performed with autologous grafts, allografts, xenografts and synthetic grafts, with all available materials presenting their own characteristics. Still, there is a current arising interest in the use of collagen fleece (TachoSil) as grafting material. We generated an extensive literature review, aiming to assess the use of TachoSil in the treatment of PD. TachoSil is currently indicated in men with PD and preserved erectile function for defect closure after partial plaque excision or incision. In addition, it is indicated for residual curvature correction during penile prosthesis implantation (PPI) in patients with PD and severe erectile dysfunction. Our literature search identified 12 studies evaluating the role of TachoSil for PD surgical treatment. We presented the surgical procedure of TachoSil grafting for the treatment of complex penile curvatures with or without simultaneous PPI and summarized the available evidence on the matter. Identified studies suggest that TachoSil is considered highly effective, reliable and safe in patients with PD. Moreover, it displays favorable properties compared to other grafting materials. It should be stressed that, despite some limitations of available data, TachoSil presents key strengths, which include easy application, decreased operative times, no risk of damaging the implant during PPI, preservation or increase in penile length, fewer cases of penile hypoesthesia, low risk of other adverse events, additional hemostatic effects and low cost. Still, randomized trials comparing TachoSil with different grafting materials are necessary to establish its efficacy.
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http://dx.doi.org/10.1038/s41443-020-00401-8DOI Listing
April 2022

Low-intensity shockwave therapy for the management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and meta-analysis.

BJU Int 2021 08 3;128(2):144-152. Epub 2021 Mar 3.

Department of Urology, School of Health Sciences, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Objectives: To perform a systematic review and meta-analysis aiming to improve the level of evidence and determine the efficacy and safety of low-intensity shockwave therapy (LiST) in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Methods: We searched PubMed, Cochrane Library and Scopus databases from inception to November 2020 for randomised controlled trials (RCTs) exploring the role of LiST for the management of CP/CPPS. We performed a random-effects meta-analysis of RCTs comparing LiST vs sham therapy on CP/CPPS symptoms at different time-points after treatment. Weighted mean differences (WMDs) with the corresponding confidence intervals (CIs) were estimated. Furthermore, we assessed the strength of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system (International Prospective Register of Systematic Reviews [PROSPERO]: CRD42020208813).

Results: We included five sham RCTs and one non-sham RCT. In the meta-analysis of sham RCTs, both the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) pain domain score and the numeric pain rating scale improved significantly after LiST vs sham therapy at the assessment directly after treatment protocol completion (WMD 3.2, 95% CI 0.88-5.52, I = 90%; and WMD 1.43, 95% CI 0.85-2.01, I = 32%, respectively), at 1 month (WMD 4.4, 95% CI 2.84-5.95, I = 68%, and WMD 2.59, 95% CI 1.92-3.27, I = 83%, respectively), and at 3 months after last treatment session (WMD 3.61, 95% CI 1.49-5.74, I = 90%, and WMD 2.64, 95% CI 2.13-3.16, I = 71%, respectively). Similarly, the NIH-CPSI total and quality-of-life domain scores improved significantly after LiST compared to sham therapy for the same time-points. Conversely, the long-term efficacy of LiST, as well as the effect of LiST on lower urinary tract symptoms and erectile function, was clinically insignificant.

Conclusions: LiST is an effective treatment modality for the improvement of pain and quality of life in patients with CP/CPPS. Therefore, it should be recommended as a part of individualised treatment strategies in such patients.
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http://dx.doi.org/10.1111/bju.15335DOI Listing
August 2021
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