MINNEAPOLIS, Nov. 17 Plethora Solutions Holdings PLC("Plethora", AIM: PLE), the specialist developer of products for the treatmentand management of urological disorders, announces results of a studyconfirming the role its product, ErecAid(R), as a supplemental first linetreatment for erectile dysfunction (ED). ErecAid(R) is marketed throughPlethora's US subsidiary, Timm Medical Technologies, Inc. ("Timm Medical",Minneapolis, MN).
The phosphodiesterase five inhibitors (PDE5i) such as Viagra(R) andCialis(R) have become a major resource in the management of ED. Unfortunately,30-50% of men report inadequate results with these oral medications. Whenpatients fail to respond to the oral medications, physicians are often forcedto consider more invasive and more complicated second line agents such aspenile injections or urethral suppositories.
New data from a multi-center clinical trial led by investigators at JohnsHopkins School of Medicine demonstrate that use of the ErecAid(R) vacuumerection device to augment PDE5i therapy can greatly improve patientsatisfaction. Results of the study were presented at a recent North CentralSectional meeting of the American Urological Association.
Investigators at four separate study sites evaluated 69 men aged 36 to 82with ED of diverse etiology who had responded inadequately to PDE5i therapy.Study subjects were allowed to continue use of PDE5i's but were instructed touse the ErecAid(R) device as an adjunct to their current oral medication.Study subjects were assessed using three validated measurements of erectilefunction and sexual satisfaction: the International Index of Erectile Function(IIEF-5), the Sexual Encounter Profile (SEP-2 and SEP-3) and the GlobalPatient Assessment Scale (GAPS).
After 4 weeks of supplemental treatment with ErecAid(R), the IIEF-5 scoreimproved substantially from a baseline of 9.0 to 17.6 (p<0.001). Moreover, ofthe 34 subjects unable to achieve an erection satisfactory for intercourse atbaseline (SEP-2 response of "no"), 27 subjects (79%) reported erectionssatisfactory for intercourse following the addition of ErecAid(R) (p<0.001).Finally, of 42 subjects reporting no or slight response to PDE5i at baseline(GAPS responses of "not at all" or "slightly"), 31 (74%) reported moderate orgreat improvement (GAPS responses of "moderately" or "greatly") at the end ofthe 4 week study (p<0.001).
According to Dr. Arthur Burnett, Professor of Urology at Johns HopkinsSchool of Medicine and the lead investigator of this trial, "This studyconfirms an earlier trial that many patients can achieve excellent resultsusing ErecAid(R) as an addition to oral PDE5i therapy. Based upon theseresults, I would encourage physicians treating ED to consider the importanceof this approach in their treatment protocols and to discuss this option withtheir patients."
About Plethora/Timm Medical:
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, erectile dysfunctionand premature ejaculation. In January 2006, Plethora acquired Minneapolis (Mn)based Timm Medical Technologies Inc., which markets products for the treatmentof erectile dysfunction (ED) to urology clinics through a US-based specialtysales team. The Company is headquartered in the UK and is listed on the LondonStock Exchange (AIM: PLE).
Further information is available at http://www.plethorasolutions.co.uk andhttp://www.timmmedical.com.
SOURCE Plethora Solutions Holdings PLC; Timm Medical Technologies, Inc.