Introduction: Men with phimosis can endure pain during sexual activity due to phimosis. This can result in anxiety impacting the patients quality of life. While the mainstay of adult phimosis treatment is circumcision, many men are apprehensive of this intervention due to perceived risk of pain, bleeding, hypersensitivity & reduced sexual pleasure. The Novoglan device stimulates new skin cell growth by applying regular controlled pressure between foreskin & glans allowing it to retract properly. We conducted a clinical trial to establish treatment efficacy, safety & tolerability of the Novoglan foreskin tissue expander & compare patient pain, discomfort & anxiety during sexual activity, pre & post treatment. Methods: Analysis of the first 20 cases in the Novoglan-01 clinical trial used ordinal & scalar outcome variables plus descriptive participant variables. Clinical Trial Participation involved two initial visits to a urology clinic, where the patients were consented, trained & their degree of phimosis determined; two phone follow-ups & a final study visit to again determine the degree of phimosis. Phimosis grades were independently assessed by Consultant Urologist on a 1 to 6 scale, where #1 represents absolutely no foreskin retraction & #6 represents full free foreskin retraction. Participant quality of life with phimosis was measured at Visit 1 & again at Final Visit based on general pain / discomfort; pain / discomfort during sexual function, & anxiety. Results: Efficacy 100% of participants observed full retraction of their foreskin (Phimosis grade 5 or 6) by the final study visit compared with 15% after the first visit. Tolerability 90% reported no pain during treatment. Sexual activity 65% did not experience pain during sexual activity by the final visit vs 5% at the initial visit. 10% experienced moderate pain during sexual activity by the final visit vs 50% at the initial visit. Anxiety 95% reported reduced level of anxiety post treatment 80% no longer considered circumcision an option post Novoglan treatment Conclusions: Novoglan-01 study confirms foreskin tissue expander balloon device is an effective, well tolerated conservative treatment for adult phimosis, enabling quality of life improvement measured by reduced levels of pain, discomfort & anxiety during sexual activity. SOURCE OF Funding: n/a
