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Long-term effects of glans penis augmentation using injectable hyaluronic acid gel for premature ejaculation

Abstract

The authors created the glans penis augmentation by injectable hyaluronic acid gel and reported the 6-month result for premature ejaculation. In a total of 38 patients, long-term effects of 5 years were compared to those of 6 months in terms of residual volume of implants and efficacy on premature ejaculation. Maximal glandular circumference measured by tapeline significantly decreased by 15% (P<0.05) but mean patient's visual estimation (Gr 0–Gr 4) did not decrease (3.60 vs 3.56, P>0.05). Compared to 6-month follow-up, intravaginal ejaculatory latency time and vibratory threshold decreased at 5 years (P<0.05), but still well increased considering those of preaugmentation. Hence, 76% of patients and 63% of partners were still satisfied. There was no serious adverse reaction. In the 5-year long-term follow-up of glans penis augmentation by filler, the implants were well maintained and effective for glans penis hypersensitivity in premature ejaculation patients.

Introduction

Currently, the chief treatment choice for premature ejaculation is medical treatment. The most important limitation of medical treatment for premature ejaculation is recurrence after withdrawal of medication.1 Efficacies of other treatments for premature ejaculation such as various topical agents and behavioral therapy are still controversial. The authors created glans penis augmentation by injectable hyaluronic acid (HA) gel (Perlane®, Q-Med, Upssala, Sweden) and reported the 6-month efficacy for penile hypersensitivity in premature ejaculation patients.2, 3, 4 Although we demonstrated the feasibility of glans penis augmentation, a major limitation was the lack of long-term results.

In this study, the authors followed the residual volume of implants and efficacy for premature ejaculation at 5 years after augmentation.

Materials and methods

The present study was conducted with the approval of the Institutional Review Boards of Korea University Medical Center and an informed consent was taken from the study populations. Among the 65 patients of glans penis augmentation for hypersensitivity of glans penis, a total of 38 patients who had a follow-up for 5 years were enrolled for this study. At 6 months and 5 years after glans penis augmentation, changes of maximal glandular diameter were measured by tapeline to identify the net change of maximal glandular circumference after augmentation of glans penis. Each measurement of the circumference was done by a single doctor to exclude interpersonal variation. The patient's subjective visual estimation of the glandular size was required for the patients to assess the residual volume of implants. The patients estimated the visual analogue scale from grade (Gr) 0 to Gr 4: Gr 0, no residual volume; Gr 1, less than 25% of initial volume; Gr 2, less than 50%; Gr 3, less than 75% and Gr 4, more than 75% or nearly same as initial volume. Intravaginal ejaculatory latency time (IELT), vibratory threshold (VT) using biothesiometer (Bio Medical Instrument Co., Newbury, OH, USA), the patient's satisfaction and the partner's satisfaction were assessed for premature ejaculation. IELT was measured by the patients with a stopwatch. The patients were educated to record IELT at least two times in the event log diary for 4 weeks and the mean IELT was analyzed. Both the patient's and the partner's satisfaction were assessed from grades 0–4: Gr 0, very dissatisfied; Gr 1, moderately dissatisfied; Gr 2, about equally satisfied and dissatisfied; Gr 3, moderately satisfied and Gr 4, very satisfied, respectively. Because most partners were reluctant to visit together, partner's satisfaction was asked by telephone. Any adverse reactions were also evaluated.

Results

Mean age of the patients was 37.7 (31–47) years in patients followed-up for 5 years. The net increase of maximal glandular circumference was 16.58±0.85 mm at 6 months and 14.10±0.65 mm at 5 years after injection. Compared to 6 months, net increase of maximal glandular circumference decreased by 15% at 5 years (Figure 1 and Table 1). (P<0.05) Mean grade of patient's visual estimation was 3.60 at 6 months and 3.56 at 5 years. There was no significant difference between 6 months and 5 years. Compared to baseline (84.2 s and 3.44 mA), IELT and VT were significantly increased to 376.7 s (270–470 s) and 9.72 mA (8–11 mA) at 6 months and 352.2 s (220–410 s) and 9.50 mA (8–11 mA) at 5 years. But, there was a significant decrease of both IELT and VT at 5 years compared to the 6-month follow-up. (P<0.05) The percentage of patient's satisfaction (Grs 3 and 4) was 76% (29/38) at 6 months and 76% (29/38) at 5 years, there was no significant difference between 6-month and 5-year follow-up. In responding partners, percentage of satisfaction was 68% (25/38) at 6 months and 63% (24/38) at 5 years. In the case of the patient's and the partner's satisfaction, there was no significant difference between 6-month and 5-year follow-up (Table 1).

Figure 1
figure1

Representative figures of injection for premature ejaculation. Grossly, the volume of implants looks unchanged until 5 years after augmentation. (a) Pre-augmentation, (b) immediately after augmentation, (c) 6 months after augmentation and (d) 5 years after augmentation.

Table 1 Results of long-term residual implants volume and efficacy for premature ejaculation

In most cases, initial discoloration by glandular swelling recovered to normal within 2 weeks. There was no abnormal reaction in area feeling, texture and color for 5 years. Postoperative consistency of glans penis was natural without deformity and maintained through 5 years. There were no signs of inflammation and no serious adverse reactions in all cases.

Discussion

In this study, the authors assessed the long-term residual volume of implants and the long-term efficacy of injectable HA for premature ejaculation. HA has been shown to possess many properties that suggest its value in several medical applications, particularly in ophthalmology, orthopedics and soft-tissue augmentation with proven efficacy and safety,5, 6, 7 but long-term efficacy studies were rarely reported. The authors thought that the major influencing factors for long-term efficacy are volume persistence and efficacy for premature ejaculation, but there is no established method to measure the residual volume of filler. The authors used maximal circumference of glans penis and the patient's subjective visual estimation for volume of residual implants. Compared to 6 months, net increase of maximal glandular circumference decreased by 15% after 5 years. But, the mean grade of the patient's visual estimation was unchanged after 5 years compared with postoperative 6 months (Gr 3.60 vs 3.56). It means that the patients might not recognize the volume loss with the naked eye. A major advantage of HA gel over nonpermanent fillers, such as fat and collagen, is the increased tissue longevity. The slow degradation of HA gel through cross-linkage enables the several hundred folds longevity of implants compared to the natural polymer, without decreased biocompatibility. The implant has a property of degradation but has a characteristic of isovolemic degradation. The isovolemic degradation always keeps the gel in balance with water in the tissue, and this increased capacity to bind water of a less concentrated hyaluronan network allows maintaining the correction even in low presence of the materials. So, the gross appearance of glans penis did not show any deformity at 5 years after augmentation in all patients.

For estimating the efficacy of premature ejaculation, IELT, VT, the patient's satisfaction and the partner's satisfaction were used. Compared to preoperative baseline (84.2 s and 3.44 mA), IELT and VT were significantly increased to 376.7 s and 9.72 mA at 6 months and 352.2 s and 9.50 mA at 5 years. The decrease of IELT and VT at 5 years from 6 months did not have any affect on the patient's and the partner's satisfaction. For several decades, various etiologies and theories were suggested for premature ejaculation. But nowadays, it is generally accepted that both biological and psychological factors are important in the pathophysiology of premature ejaculation. The biological factors such as penile hypersensitivity and lower vibration threshold are important factors in premature ejaculation and theoretical background for the development of topical agents for premature ejaculation.8, 9 Despite poor understanding of premature ejaculation, the main pathophysiology of premature ejaculation is a complex psychological phenomenon. The effects of glans penis augmentation using filler might be the results of reduced sensory of glans penis by formation of barrier for stimuli to access the receptor and increased self-esteem.

To increase the efficacy of glans penis augmentation by filler for premature ejaculation, proper patient selection is most important. As demonstrated in this study, the initial satisfaction rate of 6 month was maintained until 5 years despite significant decrease of IELT and VT. But the limitations are difficult injection technique for even distribution of the gel through whole glans penis and inevitable minor surface undulation, which originate from the undulation of underlying rete ridge. Although the undulation looks unnatural but disappears during glans erection and as a result most patients are still satisfied.

Hyaluronic acid seems to be an ideal filling substance for soft-tissue augmentation because it is biocompatible, non-antigenic, nonpyrogenic, noninflammatory, nontoxic, easy to use, stable after injection, non-migratory, long-lasting but reabsorbable, natural looking and not too expensive.10 The material used in this study is based on HA, which has already been used in its native form as an implant for more than 20 years and in millions of individuals without causing adverse reactions. Although manufacturers and different publications claim that the fillers are non-toxic and non-immunogenic, or that complications are very uncommon,11 unwanted side-effects occur with all compounds used.12, 13, 14 In the early reports of HA injection for cosmetic purposes, no significant signs of bio-incompatibility were reported.15, 16 Recent evidence may show that major, local and/or systemic, immediate or delayed adverse effects may appear in relation with its use.17 But in this study, there was no serious adverse reaction after 5 years follow-up like delayed and recurrent chronic inflammatory and granulomatous reactions.

Conclusions

In the 5-year long-term follow-up of glans penis augmentation by subcutaneous injection of HA gel, the residual volume of implants decreased by 15% of maximal glandular circumference, but was still effective for the hypersensitivity of glans penis in premature ejaculation patients.

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Acknowledgements

This work was not supported by any kind of monetary fund and declared no conflict of interest.

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Correspondence to D G Moon.

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Kwak, T., Jin, M., Kim, J. et al. Long-term effects of glans penis augmentation using injectable hyaluronic acid gel for premature ejaculation. Int J Impot Res 20, 425–428 (2008). https://doi.org/10.1038/ijir.2008.26

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Keywords

  • hyaluronic acid
  • glans penis
  • premature ejaculation
  • long-term efficacy

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