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BJU International Mar 2021To systematically review the literature in order to investigate the efficacy and safety of surgical and non-invasive penile enhancement procedures for aesthetic and...
OBJECTIVE
To systematically review the literature in order to investigate the efficacy and safety of surgical and non-invasive penile enhancement procedures for aesthetic and therapeutic purposes.
METHODS
A systematic search for papers investigating penile enhancement procedures was performed using the MEDLINE database. Articles published from January 2010 to December 2019, written in English, including >10 cases, and reporting objective length and/or girth outcomes, were included. Studies without primary data and conference abstracts were excluded. The main outcome measure was objective length and/or girth improvement. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
RESULTS
Out of 220 unique records, a total of 57 were reviewed. Eighteen studies assessed interventions for penile enhancement in 1764 healthy men complaining of small penis. Thirty-nine studies investigated 2587 men with concomitant pathologies consisting mostly of Peyronie's disease and erectile dysfunction. Twenty-five studies evaluated non-invasive interventions and 32 studies assessed surgical interventions, for a total of 2192 and 2159 men, respectively. Non-invasive interventions, including traction therapies and injection of fillers, were safe and mostly efficacious, whereas surgical interventions were associated with minor complications and mostly increased penile dimensions and/or corrected penile curvature. Overall, the quality of studies was low, and standardized criteria to evaluate and report efficacy and safety of procedures, as well as patient satisfaction, were missing.
CONCLUSION
The quality of the studies on penile enhancement procedures published in the last decade is still low. This prevents us from establishing recommendations based on scientific evidence regarding the efficacy and safety of interventions that are performed to increase the penis size for aesthetic or therapeutic indications.
Topics: Erectile Dysfunction; Humans; Hyaluronic Acid; Male; Microspheres; Organ Size; Patient Satisfaction; Penile Erection; Penile Induration; Penis; Polyesters; Polymethyl Methacrylate; Prostheses and Implants; Traction; Urogenital Surgical Procedures
PubMed: 32575166
DOI: 10.1111/bju.15145 -
International Journal of Impotence... Sep 2023The efficacy of many non-surgical treatments for Peyronie's disease is unclear. This systematic review aims to critically assess the currently available options and... (Review)
Review
The efficacy of many non-surgical treatments for Peyronie's disease is unclear. This systematic review aims to critically assess the currently available options and provide a recommendation for treatment based on this. A systematic literature search utilising the Medline (Pubmed), Embase, global health and Cochrane library databases was conducted up to May 2021. All randomised controlled trials assessing non-surgical treatment modalities for Peyronie's Disease were included. Individual study risk of bias was evaluated using the Cochrane tool and GRADE was used to assess evidence strength. Outcome measures were the change in penile curvature (degrees), plaque size (volume or size), International Index of Erectile Function score, pain scores and change in penile length. Prospero registration number: CRD42017064618. Amongst the 5549 articles identified, 41 studies (42 reports) were included. Seven different oral treatment options including vitamin E supplementation showed evidence for improving outcomes such as penile curvature and plaque size. Of the intralesional treatments, Collagenase Clostridium Histolyticum showed evidence for improving penile curvature (Range: 16.3-17 degrees, moderate level certainty of evidence). Intralesional Interferon demonstrated some improvement in curvature (Range: 12-13.5 degrees), plaque size (Range: 1.67-2.2 cm) and pain, whilst intralesional calcium channel blockers such as Verapamil showed variable evidence for changes in the plaque size and pain. Extracorporeal Shockwave Therapy consistently demonstrated evidence for improving penile pain in stable disease, and two mechanical traction devices improved curvature. Iontophoresis, topical medications, and combination therapies did not demonstrate any consistent improvements in outcome measures. Intralesional options demonstrate the best potential. Overall, results varied with few high-quality randomised trials present.
Topics: Male; Humans; Penile Induration; Treatment Outcome; Microbial Collagenase; Penis; Pelvic Pain
PubMed: 36289392
DOI: 10.1038/s41443-022-00633-w -
The Journal of Sexual Medicine Oct 2021Peyronie's disease (PD) is associated with penile pain, deviation, and sexual dysfunction. Up till now, there is no conservative standard treatment for PD. However, the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Peyronie's disease (PD) is associated with penile pain, deviation, and sexual dysfunction. Up till now, there is no conservative standard treatment for PD. However, the role of Extracorporeal Shock Wave Therapy (ESWT) is gaining increasing interest.
AIM
To evaluate the effect of ESWT on penile deviation, plaque size, erectile function, pain scale, and the rate of complications in PD patients.
METHODS
PubMed database was searched for articles published from January 2000 to November 2020, using related keywords and including randomized controlled trials (RCTs) only. Meta-analysis and forest plots were carried out using RevMan, and outcomes were reviewed by 2 authors independently. PRISMA guidelines were used in this article to achieve the quantitative and qualitative synthesis of data.
OUTCOMES
Changes in penile deviation, plaque size, erectile function, pain scale, and the rate of ESWT related complications.
RESULTS
The search yielded 73 articles. Three RCTs, including 117 patients in the ESWT group and 121 patients in the placebo group, were reviewed. ESWT is associated with reduction in plaque size (OR = 2.59, 95% CI (1.15-5.85), P= .02). No significant difference in reduction of penile deviation angle or rate of bruises were detected in post ESWT group when compared to placebo. No evidence was found to show an effect of ESWT on erectile function or pain scale.
CLINICAL IMPLICATIONS
Based on the available RCTs, ESWT fails to improve penile curvature or pain in men with PD. Although ESWT may reduce plaque size, this remains of questionable clinical significance.
STRENGTHS & LIMITATIONS
RCTs used different metrics to report the same outcome. Missed data were imputed to match the requirements of meta-analysis. However, there is still much data that cannot be estimated.
CONCLUSION
The current data suggest that ESWT fails to improve penile curvature or pain in men with PD. Although ESWT may reduce plaque size, this remains of questionable clinical significance, and further studies are required to confirm findings. Bakr AM, El-Sakka A. Extracorporeal Shockwave Therapy in Peyronie's Disease: Systematic Review and Meta-Analysis. J Sex Med 2021;18:1705-1714.
Topics: Extracorporeal Shockwave Therapy; Humans; Lithotripsy; Male; Pelvic Pain; Penile Erection; Penile Induration; Treatment Outcome
PubMed: 34511369
DOI: 10.1016/j.jsxm.2021.06.012 -
The World Journal of Men's Health Jan 2024To investigate the efficacy of medical treatment options for Peyronie's disease (PD) including oral drugs, intralesional treatment and mechanical treatment compared with...
PURPOSE
To investigate the efficacy of medical treatment options for Peyronie's disease (PD) including oral drugs, intralesional treatment and mechanical treatment compared with placebo treatment using network meta-analysis (NMA).
MATERIALS AND METHODS
We searched the randomized controlled trials (RCTs) of PD in PubMed, Cochrane library, and EMBASE up to October 2022. RCTs included medical treatment options: oral drugs, intralesional treatment and mechanical treatment. Studies reporting at least one of the outcome measures of interest including curvature degree, plaque size, and structured questionnaires (International Index of Erectile Function, IIEF) were included.
RESULTS
Finally, 24 studies including 1,643 participants met our selection criteria for NMA. There was no statistically significant treatment compared to placebo of the curvature degree, plaque size, IIEF in Bayesian analysis. The SUCRA values of ranking probabilities for each treatment performance, which indicated that hyperthermia device ranked first in NMA. However, in frequentist analysis, 7 of mono treatments (coenzyme Q10 [CoQ10] 300 mg, hyperthermia device, interferon alpha 2b, pentoxifylline 400 mg, propionyl-L-carnitine 1 g, penile traction therapy [PTT], vitamin E 300 mg) and 2 of combination treatments ("PTT-extracorporeal shockwave treatment", "vitamin E 300 mg-propionyl-L-carnitine 1 g") were statistically significant for improvement of curvature degree, and 9 of mono treatments (CoQ10 300 mg, hyaluronic acid 16 mg, hyperthermia device, interferon alpha 2b, pentoxifylline 400 mg, propionyl-L-carnitine 1 g, verapamil 10 mg, vitamin E 300 mg, vitamin E 400 U) and 3 of combination treatments ("interferon alpha 2b-vitamin E 400 U", "verapamil 10 mg-antioxidants", "vitamin E 300 mg-propionyl-L-carnitine 1 g") were statistically significant in the improvement of plaque size.
CONCLUSIONS
At present, there is no clinical treatment alternatives that have been demonstrated to be effective compared to placebo. Nonetheless, as the frequentist approach has shown that a number of agents are efficacious, further research is expected to develop more effective treatment options.
PubMed: 37382281
DOI: 10.5534/wjmh.230016 -
Sexual Medicine Reviews Jul 2021Peyronie's disease (PD) is an inflammatory disorder of the tunica albuginea causing fibrotic changes including abnormal penile curvature, pain, and erectile dysfunction....
INTRODUCTION
Peyronie's disease (PD) is an inflammatory disorder of the tunica albuginea causing fibrotic changes including abnormal penile curvature, pain, and erectile dysfunction. Approximately 10% of PD patients will have atypical features including ventral plaques, hourglass deformities, unilateral indentations, severely shortened penile length, and multiplanar curvatures. Currently, the only intralesional treatment approved by the United States Food and Drug Administration is considered off-label for atypical PD. Furthermore, treatment of atypical PD, especially ventral plaques, is met with hesitation, in part due to potential urethral injury.
OBJECTIVES
To systematically review the available literature for the safety and efficacy of intralesional injections for atypical PD.
METHODS
A thorough literature search of the PubMed database was performed on manuscripts published between 1982 and 2020. Keywords included atypical Peyronie's disease, ventral plaque, hourglass deformity, and injection.
RESULTS
15 articles met the criteria for evaluation. Overall, 1,357 patients with PD were treated with intralesional therapy, of which 250 patients were considered to have an atypical presentation. 162 (648%) of the patients were treated with intralesional collagenase Clostridium histolyticum, 49 (19.6%) with verapamil, 29 (11.6%) with interferon alfa-2b, 5 (2.0%) with hyaluronic acid, and another 5 (2.0%) with onabotulinumtoxinA. There was only 1 reported severe adverse event (penile fracture), which was surgically repaired. There were no reports of urethral injury.
CONCLUSION
Intralesional injection treatment may be a safe alternative option for atypical PD. There is a great need for future research to closely monitor the role of intralesional therapy in this cohort. Choi EJ, Xu P, El-Khatib FM, et al. Intralesional Injection Therapy and Atypical Peyronie's Disease: A Systematic Review. Sex Med Rev 2021;9:434-444.
Topics: Humans; Injections, Intralesional; Male; Microbial Collagenase; Penile Induration; Penis; Treatment Outcome; United States
PubMed: 32660728
DOI: 10.1016/j.sxmr.2020.05.003 -
The Cochrane Database of Systematic... Jul 2023Peyronie's disease is a condition that results in the development of penile plaques that can lead to penile curvature, pain, and erectile dysfunction, making sexual... (Review)
Review
BACKGROUND
Peyronie's disease is a condition that results in the development of penile plaques that can lead to penile curvature, pain, and erectile dysfunction, making sexual activity difficult. A number of non-surgical interventions exist to improve this condition, which include topical and injection agents as well as mechanical methods; however, their effectiveness remains uncertain. We performed this review to determine the effects of these non-surgical treatments.
OBJECTIVES
To assess the effects of non-surgical therapies compared to placebo or no treatment in individuals with Peyronie's disease.
SEARCH METHODS
We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings, up to 23 September 2022. We applied no restrictions on publication language or status.
SELECTION CRITERIA
We included trials in which men with Peyronie's disease were randomized to undergo non-surgical therapies versus placebo or no treatment for penile curvature and sexual function.
DATA COLLECTION AND ANALYSIS
Two of four review authors, working in pairs, independently classified studies and abstracted data from the included studies. Primary outcomes were: patient-reported ability to have intercourse, quality of life, and treatment-related adverse effects. Secondary outcomes were: degree of penile curvature, discontinuation from treatment (for any reason), subjective patient-reported change in penile curvature, and improvement in penile pain. We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.
MAIN RESULTS
Our search identified 1288 relevant references of which we included 18 records corresponding to 14 unique randomized controlled trials (RCTs) with 1810 men. These informed 10 distinct comparisons with relevant outcome data that were mostly extracted from single trials. In this abstract, we focus only on the most clinically relevant comparisons for the three primary outcomes and also include the outcome of degree penile curvature. Injectional collagenase (short-term): We found no short-term evidence on injectional collagenase for patients' self-reported ability to have intercourse and treatment-related adverse effects compared to placebo injection. Injectional collagenase may result in little to no difference in quality of life (scale 0 to 20 with lower scores indicating better quality of life; mean difference (MD) 1.8 lower, 95% confidence interval (CI) -3.58 to -0.02; 1 study, 134 participants; low CoE) and there may be little to no effect on the degree of penile curvature (MD 10.90 degrees less, 95% CI -16.24 to -5.56; 1 study, 136 participants; low CoE). Injectional collagenase (long-term): We also found no long-term evidence on injectional collagenase for patients' self-reported ability to have intercourse compared to placebo injection. It likely results in little to no effect on quality of life (MD 1.00 lower, 95% CI -1.60 to -0.40; 1 study, 612 participants; moderate CoE). Treatment-related adverse effects are likely increased (risk ratio (RR) 2.32, 95% CI 1.98 to 2.72; 1 study, 832 participants; moderate CoE). Injectional collagenase likely results in little to no change in the degree of penile curvature (MD 6.90 degrees less, 95% CI -9.64 to -4.14; 1 study, 612 participants; moderate CoE). Injectional verapamil (short-term): We are very uncertain how injectional verapamil may affect patients' self-reported ability to have intercourse compared to placebo injection short-term (RR 7.00, 95% CI 0.43 to 114.70; 1 study, 14 participants; very low CoE). We found no evidence for the outcome of quality of life. We are very uncertain how injectional verapamil may affect treatment-related adverse effects (RR not estimable; 1 study, 14 participants; very low CoE). Similarly, we are very uncertain how injectional verapamil may affect degree of penile curvature (MD -1.86, 95% CI -10.39 to 6.67; 1 study, 14 participants; very low CoE). We found no long-term data for any outcome. Extracorporeal shock wave treatment (ESWT) (short-term): We are very uncertain how ESWT affects patients' self-reported ability to have intercourse short-term (RR 1.60, 95% CI 0.71 to 3.60; 1 study, 26 participants; very low CoE). ESWT may result in little to no difference in quality of life (MD 3.10, 95% CI 1.57 to 4.64; 2 studies, 130 participants; low CoE). We are very uncertain if ESWT has an effect on treatment-related adverse effects (RR 2.73, 95% CI 0.74 to 10.14; 3 studies, 166 participants; very low CoE). ESWT may result in little to no difference in the degree of penile curvature compared to placebo (RR -2.84, 95% -7.35 to 1.67; 3 studies, 166 participants; low CoE). We found no long-term data for any outcome. Penile traction therapy (short-term): We found no evidence for whether penile traction compared to no treatment affects patients' self-reported ability to have intercourse. We are very uncertain how traction therapy may affect quality of life (MD 1.50 lower, 95% CI -3.42 to 0.42; 1 study, 90 participants; very low CoE). We are also very uncertain how traction therapy may affect treatment-related adverse effects (RR not estimable; 1 study, 90 participants; very low CoE) and how it affects the degree of curvature (MD 7.40 degrees less, 95% CI -11.18 to -3.62; 1 study, 89 participants; very low CoE). We found no long-term data for any outcome.
AUTHORS' CONCLUSIONS
There is little evidence supporting the effectiveness of most non-surgical treatments for Peyronie's disease. Existing trials are mostly of poor methodological quality and/or fail to address patient-centered outcomes. Injectional collagenase appears to have some effectiveness; however, many individuals may not experience the improvement as clinically relevant, and this comes with the risk of increased adverse events. There is a critical need for better non-surgical treatment options for men with Peyronie's disease.
Topics: Male; Humans; Penile Induration; Erectile Dysfunction; Quality of Life; Pain; Verapamil; Randomized Controlled Trials as Topic
PubMed: 37490423
DOI: 10.1002/14651858.CD012206.pub2 -
Arab Journal of Urology 2021To review recent literature pertaining to collagenase clostridium histolyticum (CCh)and other intralesional (IL) therapies for the treatment of Peyronie's disease (PD). (Review)
Review
OBJECTIVE
To review recent literature pertaining to collagenase clostridium histolyticum (CCh)and other intralesional (IL) therapies for the treatment of Peyronie's disease (PD).
METHODS
A systematic search of literature was performed using MEDLINE and PubMed.'Peyronie's Disease Clostridium Histolyticum', 'Peyronie's Disease Intralesional', 'Peyronie'sDisease Causes', and 'Atypical Peyronie's Disease' were used as query entries. Inclusion criteriarequired English text from 1980 onwards and have a full text available. Records were reviewed for study power, accuracy, and relevance to our research topic. The review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria.
RESULTS
Recent literature supports the notion that CCh is the most effective IL treatment forpatients with typical and atypical PD. The capstone CCh study was the IMPRESS trial thatshowed a 34% reduction in curvature with a mean (SD) - 17.0 (14.8)° reduction with IL CCh,while men in the placebo saw an average 18.2% decrease in penile bend with a mean (SD) - 9.3 (13.6)° per person (P < 0.001). A shortened protocol for IL CCh treatment offered a 31.4%reduction in curvature, while decreasing cost and office visits, potentially increasing patientcompliance. Lastly, literature shows CCh is used most in atypical cases, with ~64.8% of patients being treated with CCh, probably because of the high efficacy and safetyprofile that it offers. Serious complications associated with CCh include urethralinjury, corporal rupture, and penile fracture.
CONCLUSION
Since the approval of CCh by the United States Food and Drug Administration in2013, it has been a staple in the treatment of PD, and here we report the continuedsuperiority of this therapy. CCh is an effective, minimally invasive option in most PDpopulations; however, recent changes have made CCh unavailable for commercial use outside the United States, impacting many patients who have previously benefited.
PubMed: 34552787
DOI: 10.1080/2090598X.2021.1957411 -
BMC Urology Sep 2023The therapeutic role of extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) has been controversial in a long term. We aimed to further evaluate the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The therapeutic role of extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) has been controversial in a long term. We aimed to further evaluate the therapeutic effect of ESWT for PD on the basis of available high-quality studies.
METHODS
The PubMed, CENTRAL and Embase databases were searched for articles published from January 1st, 2000 to December 31, 2022. Only randomized controlled trials (RCTs) using ESWT to treat PD were included. Meta-analysis and forest plots were carried out using Review Manager 5.4.1 software, and outcomes were reviewed by 2 authors independently. Using the Risk of Bias assessment form (ROB-2) by Cochrane Collaboration for quality assessment. PRISMA 2020 guidelines were used in this article to achieve the quantitative and qualitative synthesis of data.
RESULTS
A total of four RCTs were included. 151 patients in the ESWT group and 150 patients in the control group. The meta-analysis results showed that ESWT could significantly reduce plaque size (OR 2.59, 95%CI 1.15 to 5.85, P = 0.02) and relieve pain (MD -1.55, 95%CI -2.46 to -0.64, P = 0.0008); but it has no significant effect on reducing the penile curvature (OR 1.93, 95%CI 0.87-4.26, P = 0.11) and improving sexual function (MD 2.6, 95%CI -1.63 to 6.83, P = 0.23), there is also no significant difference in complication rates between groups (OR 2.94, 95%CI 0.66 to 13.03, P = 0.16). The risk of bias of results is low. The limitations of this study are that the number of included studies is too small, some experimental outcomes are missing, and the expression of outcomes is not unified.
CONCLUSIONS
For PD, ESWT can be considered as a safe short-term treatment, which can reduce plaque size and relieve pain, but cannot improve penile curvature and sexual function. Its long-term efficacy remains to be discussed.
REGISTRATION NUMBER
PROSPERO (ID: CRD42023436744).
Topics: Male; Humans; Penile Induration; Extracorporeal Shockwave Therapy; Penis; Databases, Factual; Pain
PubMed: 37700253
DOI: 10.1186/s12894-023-01320-8 -
Sexual Medicine Reviews Oct 2020Evidence for noninvasive management of Peyronie's disease contains many options with varying levels of evidence for each. Many first-line treatments recommended by...
INTRODUCTION
Evidence for noninvasive management of Peyronie's disease contains many options with varying levels of evidence for each. Many first-line treatments recommended by urologists lack strong evidence for their use.
AIM
We summarize the noninvasive (oral medications, topical medications, traction, vacuum erection devices, extracorporeal shock wave therapy, intracavernosal injections and electromotive therapy) treatment options for Peyronie's disease and provide the levels of evidence for each.
METHODS
A literature search of PubMed, EMBASE, Cochrane Library, and ClinicalKey databases was conducted, current up to April 2019.
MAIN OUTCOME MEASURE
For each treatment modality, we measured level of evidence, change in penile curvature, change in erectile function, the percentage of patients with improved angulation, and pain scores.
RESULTS
There is weak evidence to support the use of oral or topical medications. Higher levels of evidence exist for intracavernosal injections and extracorporeal shock wave therapy and may be helpful in certain patient populations.
CONCLUSION
The mechanisms behind Peyronie's disease are not fully understood. Penile injections provide the highest quality of evidence for noninvasive treatment. Ory J, MacDonald L, Langille G. Noninvasive Treatment Options for Peyronie's Disease. Sex Med Rev 2020;8:603-614.
Topics: Disease Management; Evidence-Based Medicine; Humans; Male; Penile Induration; Treatment Outcome
PubMed: 31983573
DOI: 10.1016/j.sxmr.2019.12.002 -
Sexual Medicine Reviews Mar 2024Peyronie's disease (PD) can have an immense psychological impact, with depression being a reported possible, severe consequence. To date, no literature reviews have... (Review)
Review
INTRODUCTION
Peyronie's disease (PD) can have an immense psychological impact, with depression being a reported possible, severe consequence. To date, no literature reviews have systematically and critically assessed the relationship between PD and depression.
OBJECTIVES
The study sought to identify and critically appraise the current literature on the association between PD and depression.
METHODS
Studies had to address men with PD or probable PD and assess depression or depressive symptoms. Quantitative and qualitative, peer-reviewed, primary, empirical studies written in English or Danish were included. According to the guidelines for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews) guideline, we performed a systematic review of PubMed, PsycINFO, Embase, CINAHL, the Cochrane Library, and Web of Science. Reference lists of included studies were screened for additional sources. Gray literature was searched for in Google Scholar and Bielefeld Academic Search Engine. Data were charted using a data extraction form, and critical appraisal was performed using the QuADS (quality assessment with diverse studies) tool.
RESULTS
Thirteen studies were included. Most studies had a cross-sectional design, and also cohort studies and longitudinal observational studies without a control group were found. Depression was assessed mainly by validated questionnaires or diagnostic codes. Questionnaire studies found a prevalences of moderate to severe depression of 24% to 48%, while studies using diagnostic codes found depression in 4% to 37% of men with PD. The quality of the included studies varied from 38% to 82% of the maximum possible score in the QuADS assessment.
CONCLUSION
While most studies describe an association between PD and depression, the evidence is not comprehensive. The current literature is especially at risk of selection bias and the influence of confounding factors, and a direct causality between PD and depression cannot be established. Future research calls for more methodically rigorous studies as well as qualitative studies to understand the relationship.
Topics: Male; Humans; Penile Induration; Cross-Sectional Studies
PubMed: 37902293
DOI: 10.1093/sxmrev/qead045