Safety of Durasphere for the Treatment of True Hypermobile Glans Penis

Authors: Jared J Wallen MD, SriGita K Madiraju DO, Martin S Gross MD, Tariq S Hakky MD, Paul E Perito MD

Key words: Floppy Glans Syndrome, Penile Implant, Penile Prosthesis, Erectile Dysfunction, Hypermobile Glans, True Glanular Hypermobility

Introduction and Objective: Despite proper sizing and placement of a penile implant there is a subset of patients whom complain of the sensation of a soft glans penis, pain during intercourse by either participant due to pressure from the cylinder tips, or the appearance of droopy glans penis even with the implant maximally inflated. True hypermobility of the glans penis exists in the setting of a properly sized and positioned implant. DurasphereTM (Coloplast) is a safe, sterile non-pyrogenic bulking agent composed of carbon coated zirconium beads suspended in a water-based beta-glucan gel that has long been used as a bulking agent in the treatment for urinary incontinence caused by intrinsic sphincter deficiency (ISD). Here we present our results of subcoronal Durasphere injections as a procedural treatment for the post penile prosthesis true hypermobile glans. Methods: Retrospective review of from 2014-2019 reveals 30 patients whom underwent a total 95 subcoronal Durasphere injections with a range of 1-12 injections respectively, staged at no more than 4 cc per treatment. The diagnosis of true glanular hypermobility requires expert evaluation and ensuring that the penile implant is of appropriate size and position as to not be confused with floppy glans syndrome (SST), which is caused by an undersized implant and requires surgical revision of the implant itself. All patients underwent preoperative expert evaluation and were determined to be candidates for this glandular bulking procedure. Results: All 30 patients have follow-up on average of 58.8 weeks. Greater than 80% reported satisfaction, however only 50% responded to satisfaction survey. Three (3) adverse events (AE) have been reported as of this time. All of which were cutaneous in nature and healed with local wound care. Potential AEs to be mindful of in following these patients are glandular or urethral erosion, implant infection, implant puncture/malfunction, cellulitis, urethral stricture, deviation of urinary stream, or dermal tattooing. Conclusions: Durasphere has a proven track record in the safety profile for ISD and our initial data suggests that similar results are obtainable for the treatment of true glandular hypermobility in experienced hands. We suggest subcoronal Durasphere injections should be a viable option in the armamentarium of treatments for glandular hypermobility due to high patient satisfaction, low adverse events, and ease of intervention.

Acknowledgements: Funding was Provided by Coloplast Corp for Artistry in portions of video.

Disclosures: Wallen none; Madiraju none; Gross Consultant for Coloplast; Hakky consultant for Coloplast; Perito Consultant for Coloplast and Boston Scientific.

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