Adult phimosis, defined by the inability to retract the foreskin, is traditionally treated with topical corticosteroids or circumcision. However, these options may not suit all patients. Novoglan, a custom-moulded balloon device designed for gentle foreskin tissue expansion, offers a conservative, non-surgical alternative. While clinical trials report high safety, efficacy, and tolerability, post-marketing surveillance (PMS) provides critical insight into real-world performance. This study consolidates data from a clinical trial, a large PMS study involving 811 patients, and a two-year long-term follow-up to assess short- and long-term outcomes of Novoglan treatment.

Three datasets were evaluated: Novoglan-01 Clinical Trial (TAU 2023): Prospective, open-label, multi-center study of 20 adult males with phimosis, evaluating outcomes after 6–8 weeks of once-daily Novoglan use. Post-Marketing Surveillance (UAA 2023): Real-world evaluation of 811 Novoglan users, focusing on usability, safety, tolerability, and self-reported treatment efficacy across varied demographics. Long-Term Follow-Up (USANZ NSW 2024): Two-year post-treatment assessment of Novoglan-01 participants, evaluating sustained success, recurrence, and need for further intervention. Primary endpoints included resolution of phimosis, adverse events, and patient-reported usability. Secondary outcomes addressed psychological well-being and satisfaction over time.

Short-Term (6–8 weeks): Clinical trial: 95% (19/20) achieved full foreskin retraction without surgery. PMS study: 91% of 811 participants reported success, with improved satisfaction linked to updated device design. 15% of clinical trial participants experienced mild, transient discomfort early in treatment, which resolved without affecting adherence. Long-Term (2 years): 95% (19/20) of trial patients maintained full resolution without recurrence. No successfully treated patient required circumcision or further intervention. No new or late-onset adverse effects were reported, supporting long-term safety and effectiveness.

Combined analysis of clinical, real-world, and long-term data confirms Novoglan as a safe, effective, and well-tolerated non-surgical treatment for adult phimosis. High short-term success rates (91–95%) were sustained at two years (95%) with no relapse or surgical need. Minor discomfort was self-limiting and did not impact treatment continuation. These findings support Novoglan as a durable, patient-preferred alternative to circumcision and emphasize the importance of integrating clinical and real-world evidence in urological device evaluation.