#1484 Systematic Review and Meta-analysis of the Association Between CONUT Score and High-Grade Postoperative Complications in Bladder Cancer Patients Undergoing Radical Cystectomy
#992
Short and Long-Term Efficacy, Safety, and Usability of Novoglan for Adult
Phimosis: Clinical Trial Data vs. Real-World Outcomes from 811 Patients
Eric Chung1, Dmitry Polikarpov2, Herbert Mazure3, Andrew James4, Hassan Doosti5, Douglas Campbell6, David Gillatt7
1 Princess
Alexandra Hospital, Urology, Brisbane,
2 Northern Beaches Hospital, Urology, Sydney,
3 HGM Consulting, Sydney, Australia,
4 Platigo Solutions, Sydney, Australia,
5 Macquarie University, Sydney, Australia,
6 Minomic International, Sydney, Australia,
7 Macquarie University, Urology, Sydney
Introduction:
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.
Materials and Methods:
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.
Results:
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.