Oral Administration and Intralesional Injection of Hyaluronic Acid <i>Versus</i> Intralesional Injection Alone in Peyronie's Disease: Results from a Phase III Study

Cai, Tommaso; Tiscione, D.; Favilla, Vincenzo; Puglisi, Marco; Palumbo, Fabrizio; Zucchi, Alessandro; Malossini, G.; Palmieri, Alessandro; Johansen, Truls E. Bjerklund

doi:10.5534/wjmh.200048

Cited by 12 publications

(8 citation statements)

References 11 publications

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“…One major limitation was the lack of a control group of placebo‐treated patients 28 . Finally, Cai et al 29 published a prospective randomized phase III study with 81 PD patients enrolled at two centers and randomized to oral HA administration (a combination of extracts of HA, avocado, and soy unsaponifiable substances) combined with intralesional HA (0.8% highly purified sodium salt HA 16 mg/2 ml) ( n = 41 patients) as compared with intralesional treatment only ( n = 40 patients). Outcomes considered were changes in penile curvature, IIEF, and PGI‐I questionnaire.…”

Section: Resultsmentioning

confidence: 99%

Clinical use of hyaluronic acid in andrology: A review

et al. 2021

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Background: Hyaluronic acid is a glycosaminoglycan widely used in the fields of orthopedics, ophthalmology, and aesthetic medicine due to its significant ability to reduce the synthesis of pro-inflammatory proteins and its activity against oxidative stress, a feature of many degenerative illnesses. Objectives:The objective of the present review is to provide a comprehensive narrative review of the most recent literature on the use of hyaluronic acid in andrology in order to facilitate the use of this therapeutic device in the common clinical practice of many physicians. Specific conditions covered in the review are Peyronie's disease, premature ejaculation, and penile enlargement. Materials and methods:A broad and comprehensive literature search included Medline, EMBASE, and the Cochrane Libraries, with no time restriction up to December 2020 and restricted to English language publications. Unpublished studies were not included. The study was registered as "The role of hyaluronic acid in andrology: A systematic review and meta-analysis" in PROSPERO with the ID CRD42021223416.Discussion and conclusion: Hyaluronic acid is a valid choice for the treatment of Peyronie's disease in terms of the resolution of the acute phase of the disease and of contributing to stabilizing the disease as a bridge to potential surgery. Data, furthermore, suggest that hyaluronic acid is frequently associated with an overall clinical improvement, allowing the patient to resume normal sexual activity.With regard to premature ejaculation, data suggests hyaluronic acid-based treatments were effective in prolonging intra-vaginal ejaculation time. Furthermore, hyaluronic acid was found to be safe and well-tolerated, with main adverse events limited to local discomfort, ecchymosis, papule formation, and glans numbness, all of which were reported to resolve spontaneously.Last, with regard to penile enlargement, the overall perception of experts is that hyaluronic acid may be an extremely well-tolerated compound with potential for application in specific areas of male sexual health that are often neglected as compared to more common, and relatively simpler to treat, conditions.

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Section: Resultsmentioning

confidence: 99%

Clinical use of hyaluronic acid in andrology: A review

et al. 2021

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“…Group B consisted of 40 patients who received weekly intralesional injections of HA for 6 weeks only. The authors reported that oral administration combined with intralesional treatment with HA had greater efficacy to improve PC and overall sexual satisfaction in comparison with intralesional HA treatment alone (13).…”

Section: Discussionmentioning

confidence: 99%

Long-Term Outcomes (2 Years) After Hyaluronic Acid Therapy for Peyronie’s Disease

Cocci

Mauro²,

Mondaini

et al. 2022

Front. Urol.

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BackgroundHyaluronic acid (HA) has demonstrated clinical benefits for the treatment of Peyronie’s disease (PD); however, there are no reports that documented long-term outcomes. The aim of the current study is to illustrate the clinical outcomes after 2 years of follow-up in patients who received HA for PD.MethodsFrom January 2015 to December 2018, we enrolled 244 patients affected by PD in this multicenter non-randomized clinical study, as previously reported. Patients received intralesional HA (Group A) or verapamil (Group B). Follow-up was undertaken after 3 months, 1 year, and 2 years. International Index of Erectile Function (IIEF-5), PC, and visual analogue scale (VAS) were collected.ResultsAmong the whole cohort, 125 patients were included in Group A and 119 in Group B. As PC, the median curvature was 25.0° at 3 months [interquartile range (IQR), 15.0–30.0] (p=0.45) and was maintained at 1 (p=0.87) and 2 years of follow-up (p=0.90) (Group A), while it was 30.0° (IQR, 20.0–35.0) (p=0.67) at 3 months and was stable at 1 (p=0.77) and 2 years of follow-up (p=0.80) (Group B). For VAS score, the median change in Group A was −4.0 (IQR, −4.0, −5.0, p<0.01) after 3 months, −4.0 (IQR, −4.0, −5.0, p<0.01) at 1 year, and −4.0 (IQR, −4.0, −5.0, p<0.01) at 2 years of follow-up, while in Group B, it was −1.0 (IQR, −2.0, −0.5, p=0.25) after 3 months, −3.5 (IQR, −3.5, −2.0, p<0.01) at 1 year, and −4.0 (IQR, −4.0, −5.0, p<0.01) at 2 years of follow-up. Adjusted p-value for between-group comparisons was <0.01 at 3 months and not significant at 1 (p=0.53) and 2 years (p=0.80).ConclusionsWe reported clinical efficacy of intralesional HA in patients with PD after 2 years of follow-up by slightly improving penile curvature (PC) and bother of the disease. These results should be considered during the counseling of the patients especially regarding the lack of worsening over time.

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“…The combination of intralesional administration and oral administration showed greater efficacy in reducing penile deviation and improving sexual function. [65] Topical therapy for PB Iontophoresis (EMDA, electromotive drug administration). Iontophoresis is a method using galvanic current to improve the penetration of drugs to the desired tissues -in this case the corpora cavernosa of the penis [66].…”

Section: Therapeutical Ultrasoundmentioning

confidence: 99%

Мodern Non-Invasive Methods for Treating Peyronie's Disease

Tosev

Vladeva

Dimov

2023

RS Global - World Science

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Summary: Peyronie's disease (PD) is a common disease in men that can lead to significant penile deformity and pain, erectile dysfunction, and mental health problems. So far, surgical correction with plaque removal offers the greatest likelihood of success during the stable phase of the disease. However, for men in the acute phase of PD or those with a milder deformity who choose to avoid surgery, conservative treatment methods are also available. New innovative methods are extracorporeal shock wave therapy (ESWT) and ultrasound therapy. Intralesional therapy with IFN-α2b, verapamil, and Clostridium histolyticum (CCH) collagenase can significantly reduce penile deviation (PD), but these results may not be clinically significant in men with more severe disease. Iontophoresis (EMDA, electromotive drug administration) of verapamil and cortisone have shown reductions in PD and penile pain.Penile traction therapy offers clinically significant improvement in penile length and curvature. It requires daily therapy lasting several hours. Oral therapies with substances such as L-arginine, L-citrulline, vitamin E and phosphodiesterase inhibitors are most helpful as part of a combination regimen rather than as monotherapy. Regenerative therapies with stem cells and platelet-rich plasma, as well as intralesional therapy with botulinum toxin (Botox) have not yet been well clinically studied and their possible application is currently taking place within the framework of clinical research. The combination of various oral, topical, intralesional therapies, extracorporeal shock wave therapy, ultrasound and traction therapies together with clinical psychosexual therapy if needed could provide a more effective treatment, which in turn could prevent or reduce the need for definitive reconstructive penile surgery. Materials and methods: For the purposes of the literature review, a systematic search was conducted for articles in German and English on non-invasive treatment methods for Peyronie's disease. The articles were selected according to their relevance to the given topic. The main findings were summarized and presented in tabular form.

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Oral Administration and Intralesional Injection of Hyaluronic Acid Versus Intralesional Injection Alone in Peyronie's Disease: Results from a Phase III Study

Cited by 12 publications

References 11 publications

Clinical use of hyaluronic acid in andrology: A review

Clinical use of hyaluronic acid in andrology: A review

Long-Term Outcomes (2 Years) After Hyaluronic Acid Therapy for Peyronie’s Disease

Мodern Non-Invasive Methods for Treating Peyronie's Disease

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