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Urology Dec 2018To accurately characterize the effect of penile traction therapy (PTT) on stretched penile length (SPL) after primary treatment for men with PD. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To accurately characterize the effect of penile traction therapy (PTT) on stretched penile length (SPL) after primary treatment for men with PD.
MATERIALS AND METHODS
A systematic search was performed for studies that evaluated the correction of PD using penile traction as secondary treatment published through January 2018. Studies were included if (1) a singular primary treatment of PD (injection or surgical treatment) was performed for all included men, (2) if there was a control group with no adjunct traction, and (3) if patients were required to wear the traction device for greater than 2 h/d. Estimates were pooled using random-effects meta-analysis.
RESULTS
Data were obtained from 4 studies involving 348 men with an average age of 55.7 ± 2.0 years. Men who used PTT after primary intervention had SPLs 1.02 cm greater [95% CI: 0.64 to 1.40; I=0%] when compared with men who did not use traction after primary intervention (p = 0.009). When performing subgroup analysis by primary therapy, no difference was seen in men undergoing penile traction after surgical correction when compared with men undergoing penile traction after injection therapy (1.01 vs 1.29 cm, p = 0.84).
CONCLUSION
PTT may be a promising technique to reduce length loss in men undergoing PD treatment. Future work should be done to determine the ideal timing and subpopulations who would benefit from PTT.
Topics: Combined Modality Therapy; Humans; Male; Organ Size; Patient Selection; Penile Induration; Penis; Treatment Outcome; Urological Agents
PubMed: 30099127
DOI: 10.1016/j.urology.2018.07.039 -
Expert Opinion on Investigational Drugs Jul 2018The prevalence of sexual dysfunctions has increased over the last decades; despite a number of available treatments for erectile dysfunction (ED), premature ejaculation... (Review)
Review
INTRODUCTION
The prevalence of sexual dysfunctions has increased over the last decades; despite a number of available treatments for erectile dysfunction (ED), premature ejaculation (PE), and Peyronie's disease (PD), still several unmet therapeutic needs deserve to be fulfilled. The aim of this review is to detail on phase I and II clinical trials investigating novel medical treatments for ED, PE, and PD.
AREAS COVERED
We conducted a systematic review of the literature including both published and ongoing phase I and II registered trials focused on medical treatment of ED, PE, and PD during the last 5 years. A total of 35 trials have been identified. Most studies (63%) investigated ED treatments and 26% were still ongoing. Stem cells (SCs) therapy was assessed in 28% of trials.
EXPERT OPINION
SCs therapy represent a promising treatment for ED although only few patients have been treated to date. Likewise, the oral selective oxytocin receptor antagonists for treating PE showed excellent safety profile and deserve further investigations in phase III trials. Preliminary results of novel topical treatments for PD with fibrinolytic and antiinflammatory drugs are encouraging, but urgently need to be confirmed in large placebo-controlled trials.
Topics: Animals; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Drug Design; Erectile Dysfunction; Humans; Male; Penile Induration; Premature Ejaculation; Prevalence; Stem Cell Transplantation
PubMed: 29969332
DOI: 10.1080/13543784.2018.1495707 -
Urology Practice Jan 2018The discovery of biological targets in the fibrosis pathway has led to the advent of many potential therapies for fibrotic diseases. During the last 2 decades an... (Review)
Review
INTRODUCTION
The discovery of biological targets in the fibrosis pathway has led to the advent of many potential therapies for fibrotic diseases. During the last 2 decades an increasing number of large, randomized studies on antifibrotic medications in urology have evaluated its efficacy, safety and long-term outcomes. Although there are many established therapeutics with antifibrotic properties, we focused on the 6 antifibrotic agents that are most currently relevant to the field of urology, including clostridial collagenase histolyticum, mitomycin C, halofuginone, triamcinolone acetonide, verapamil and interferon. We evaluate and summarize the existing published literature on these antifibrotic drugs with a particular emphasis on their safety and efficacy in urological diseases.
METHODS
Using the MEDLINE® database, Cochrane Library Central Search, Web of Science and Google Scholar we reviewed all published articles from 1976 to 2016 using the search terms antifibrotics and urology. The literature was searched for pharmaceuticals with antifibrotic properties and efficacy in urological disease, and the 6 most extensively researched drugs were documented. These antifibrotic drugs were then individually reviewed using the databases previously mentioned, and the safety, efficacy and long-term outcomes of each drug were analyzed and summarized.
RESULTS
Our search yielded 63 peer reviewed publications on the use of antifibrotic agents in the field of urology. Clostridial collagenase histolyticum has been studied the most thoroughly in this group, with 19 articles and Food and Drug Administration approval for use in Peyronie's disease. The majority of the publications was prospective or randomized controlled studies. Mitomycin C and triamcinolone acetonide can reduce urethral stricture recurrence at a mean followup period of 1 to 2 years and mitomycin C has been effective in curing recurrent bladder neck contractures. Halofuginone and verapamil have shown efficacy for Peyronie's disease and urethral stricture.
CONCLUSIONS
This systematic review summarizes the existing literature on the use of antifibrotic drugs for urological disease. Safety, efficacy and long-term outcomes for each drug are evaluated for various disease types and current recommendations for use are reviewed. This systematic review also details the potential therapeutic roles of several antifibrotic medications for treating common urological conditions and diseases, showing that they can be important, useful and effective additions to the urologist's armamentarium.
PubMed: 37300208
DOI: 10.1016/j.urpr.2016.11.011 -
Sexual Medicine Reviews Apr 2017Stem cells for sexual disorders are steadily being introduced into clinical trials. Two conditions of importance are the main target for this line of treatment,... (Review)
Review
INTRODUCTION
Stem cells for sexual disorders are steadily being introduced into clinical trials. Two conditions of importance are the main target for this line of treatment, especially when regarding the wide array of translational and basic science highlighting the potential advantages of regenerative therapy: erectile dysfunction (ED) and more recently Peyronie disease (PD). Cellular therapy offers a treatment modality that might reverse disease progression. It would be used in a curative setting, in contrast to other pharmaceutical agents that are currently available.
AIM
To review basic preclinical studies and recent clinical trials of stem cells on ED and PD.
METHODS
A search of the medical literature for the following terms was performed using PubMed: stem cells, cellular therapy, erectile dysfunction, Peyronie's disease, and clinical trial.
MAIN OUTCOME MEASURES
A non-systematic narrative review and critical reflection on preclinical and clinical studies administering stem cells for ED and PD in animal models and human subjects.
RESULTS
Numerous studies have confirmed the beneficial functional effects of stem cell injection in established animal models on ED and PD. Various stem cell types have been adopted, from embryonic to adult mesenchymal cell types. Each cell type offers distinctive advantages and disadvantages. Diverse administrations of stem cells were investigated, with insignificant variability in the ultimate results. Stem cells appear to have a pronounced paracrine effect, rather than the classic engraftment and differentiation hypothesis. Phase 1 clinical trials using stem cells have not reported any severe adverse events in animals. However, these results cannot be extrapolated to draw any conclusions about efficacy in human patients.
CONCLUSION
Stem cells have an established efficacy in preclinical studies and early clinical trials. Studies are currently being published demonstrating the safety of intrapenile injection of autologous bone marrow- and adipose tissue-derived stem cells. Soebadi MA, Milenkovic U, Weyne E, et al. Stem Cells in Male Sexual Dysfunction: Are We Getting Somewhere? Sex Med Rev 2017;5:222-235.
Topics: Aging; Animals; Clinical Trials as Topic; Diabetes Complications; Erectile Dysfunction; Humans; Male; Metabolic Syndrome; Penile Diseases; Prostatectomy; Stem Cell Transplantation
PubMed: 28041853
DOI: 10.1016/j.sxmr.2016.11.002 -
Actas Urologicas Espanolas Oct 2017The low-intensity shockwave (LISW) therapy is a recently developed modality for treating erectile dysfunction. (Meta-Analysis)
Meta-Analysis Review
CONTEXT
The low-intensity shockwave (LISW) therapy is a recently developed modality for treating erectile dysfunction.
OBJECTIVE
To assess the efficacy of LISW therapy for treating erectile dysfunction as described in the literature.
ACQUISITION OF EVIDENCE
Two independent reviewers identified studies eligible for a systematic review and meta-analysis of various sources written in English and Spanish, using the databases of PubMed, EMBASE and Web of Science. We excluded studies on Peyronie's disease. We employed the DerSimonian-Laird method for defining heterogeneity, calculating the grouped standard deviation of the mean (SDM). The primary objective of this review is to assess efficacy based on the change in the International Index of Erectile Function (IIEF-EF) over baseline at 1 month from the start of treatment, both for the treatment arm and the placebo arm. The secondary objective is focused on analysing IIEF-EF at 3-6 months from the start of the therapy.
SUMMARY OF THE EVIDENCE
The pooled data of 636 patients from 12 studies showed that treatment with LISW resulted in a significant increase in IIEF-EF at 1 month with respect to baseline (SDM, -2.92; P=.000), to a greater degree than placebo (SDM, -.99; P=.000). The IIEF-EF at 3-6 months for the treated patients was significantly greater than baseline (SDM, -2.78; P=.000). Only one study compared the efficacy of placebo at 3-6 months versus baseline (SDM, -9.14). The comparison between LISW and placebo favours active treatment (SDM, 2.53; P=.000) at 1 month. There are insufficient data in the literature to assess the response over placebo at 3-6 months.
CONCLUSIONS
According to the literature, treatment with LISW for erectile dysfunction is effective, both in the short and medium term. LISW has been described as more effective than placebo in the short term. The long-term efficacy data are insufficient. More studies are needed to explain the role of this therapy according to specific causes of erectile dysfunction.
Topics: Erectile Dysfunction; Extracorporeal Shockwave Therapy; Humans; Male; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome
PubMed: 27521134
DOI: 10.1016/j.acuro.2016.07.005 -
World Journal of Urology Jan 2017The objective was to evaluate high-level evidence studies of extracorporeal shock wave therapy (ESWT) for urological disorders. (Review)
Review
PURPOSE
The objective was to evaluate high-level evidence studies of extracorporeal shock wave therapy (ESWT) for urological disorders.
METHODS
We included randomized controlled trials reporting outcomes of ESWT in urology. Literature search on trials published in English using EMBASE, Medline and PubMed was carried out. The systematic review was performed according to PRISMA guidelines.
RESULTS
We identified 10 trials on 3 urological indications. Two of 3 trials on Peyronie's disease (PD) involving 238 patients reported improvement in pain; however, no clinical significant changes in penile deviation and plaque size were observed. Four studies on erectile dysfunction (ED) including 337 participants were included. Using International Index of Erectile Function (IIEF-EF) and erectile hardness scale (EHS) data suggested a significant positive effect of ESWT in phosphodiesterase-5 inhibitor (PDE-5i) responders in 2 of 4 trials and 3 of 4 trials, respectively. Three studies on chronic pelvic pain (CPP) engaging 200 men reported positive changes in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). There was considerable heterogeneity between trials both with regard to treatment techniques and outcome measures, making it difficult to compare results.
CONCLUSIONS
ESWT may resolve pain in PD patients, while evidence for reducing curvature and plaques size is poor. Effects of ESWT on IIEF in ED patients are inconsistent; however, data on EHS does imply that the treatment potentially may recover natural erection in PDE-5i responders. ESWT seems to be able to resolve pain in CPP patients in the short term. In all three disease entities, long-term outcome data are still warranted.
Topics: Chronic Pain; Erectile Dysfunction; Female; High-Energy Shock Waves; Humans; Male; Pelvic Pain; Penile Induration; Phosphodiesterase 5 Inhibitors; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 27108421
DOI: 10.1007/s00345-016-1834-2 -
The Journal of Sexual Medicine Apr 2016Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements... (Review)
Review
INTRODUCTION
Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago.
AIM
To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed.
METHODS
A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria.
MAIN OUTCOME MEASURES
Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses.
RESULTS
Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis.
CONCLUSION
Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function.
Topics: Adult; Erectile Dysfunction; History, 20th Century; Humans; Male; Penile Implantation; Penile Prosthesis; Penis; Postoperative Complications; Plastic Surgery Procedures; Referral and Consultation; Treatment Outcome
PubMed: 27045255
DOI: 10.1016/j.jsxm.2016.01.017