Clinical Update

22 Aug 2006 07:01

Plethora Solutions Holdings PLC22 August 2006 22nd August 2006 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update ErecAidTM: Clinical Data Demonstrates Improvement in Sexual Function with Earlyuse of Vacuum Therapy Devices post Radical Prostate Surgery Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,notes the publication of new research that confirms vacuum therapy devices suchas the ErecAid product marketed through Plethora's US subsidiary, Timm Medical,when used in a rehabilitative fashion after radical prostatectomy, provide aquicker return to preoperative sexual function and may preserve penile length.ErecAid is the US market leader in vacuum therapy devices with over 1 millionpatients having successfully received treatment. In a paper published by a clinical group headed by Dr Manoj Monga of theUniversity of Minnesota and presented at The World Congress of Endourology (18thAugust 2006), data from an ongoing clinical study have shown that earlyinitiation of the use of a vacuum therapy device (VTD) such as the ErecAidsystem after radical prostatectomy not only improves sexual function but mayalso help to preserve penile length. In this study, patients were randomised either into an 'Early' patient groupwith use of the VTD from 1 month after the operation or a 'Traditional' groupusing the device 6 months after surgery. Subjects were evaluated using theInternational Index of Erectile Function (IIEF) where a score of >11 means thereis no evidence of erectile dysfunction. All patients in the study had apreoperative IIEF score of >11. The preliminary data reported that post-operative IIEF scores were significantlyhigher in the 'Early' group compared with the 'Traditional' group at both 3months (p=0.002) and 6 months (p=0.029). Less patients in the 'Early' groupsuffered from moderate to severe ED at 3 months (60% versus 100%, p=0.002) and 6months (50% versus 100%, p=0.03). Significant shortening of the stretched penilelength was seen in 27% of the 'Early' group compared to 64% in the 'Traditional'group (p=0.06) at the last follow up visit. Men treated for localised prostate cancer by either radical prostatectomy orradiotherapy can expect some degree of erectile dysfunction (ED) and thecondition may persist long into the recovery period. Prostate cancer screeninghas led to the detection of more cases in younger men and an increasing focus onrestoring sexual activity after treatment. According to the American CancerSociety, around 230,000 new cases of prostate cancer will be diagnosed in theUnited States during 2005. The majority will have localised (Stage II) diseaseat diagnosis and between 25 and 30% of this patient group will be treated byradical prostatectomy, resulting in a potential penile rehabilitation treatmentpopulation of around 50,000 patients each year in the United States alone. Previous studies have indicated that early penile rehabilitation can reduce theimpact of ED. Nerve damage after radical prostatectomy causes a loss of naturalnocturnal erections, reducing blood flow to the penis which causes fibrosis ofthe penile tissue, resulting in a reduction in penile length. Early penilerehabilitation is aimed at increasing blood flow to the penis so that the peniletissue is maintained while nerve function is restored. The efficacy of oral EDdrugs is greatly reduced in patients with nerve damage so alternative treatmentsare required. Dr. Mike Wyllie, Plethora's Chief Scientific Officer, said: "For many patients suffering from ED, treatment using oral medication is not anoption. For these patients, vacuum therapy devices like ErecAid have a successrate of over 90%. It is encouraging to see results from this new study showingthat early initiation of treatment with a vacuum therapy device is effectivepenile rehabilitation therapy in a patient population that responds relativelymodestly to oral therapy due to nerve damage associated with surgery." -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell City/Financial Enquiries Tel: 020 7379 5151MaitlandBrian Hudspith/Liz Morley/Wendy Timmons Scientific/Trade Press Enquiries Tel: 020 7861 3838DeFacto CommunicationsRichard Anderson About Plethora: Plethora is focused on the development and marketing of products for thetreatment of urological disorders. The Company has products in clinicaldevelopment for the treatment of overactive bladder, stress urinaryincontinence, interstitial cystitis, gynaecological pain and prematureejaculation. In January 2006, Plethora acquired Minneapolis (Mn) based TimmMedical Technologies Inc which markets products for the treatment of erectiledysfunction (ED) to urology clinics through a US-based specialty sales team. TheCompany is headquartered in the UK and is listed on the London Stock Exchange(AIM:PLE) Further information is available at www.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange