The Efficacy of Injection Penile Girth Enhancement as an Option for Small Penis Syndrome Management

Abstract

Background

In recent years aesthetic injection techniques with soft tissue fillers have become popular worldwide due to their effectiveness, safety, and low cost. There is no standard approach to the management and follow-up of patients seeking penile enlargement procedures described in the literature, and the surgical penile enlargement methods are controversial.

Objectives

The goals of this study were to assess the effect of injection penile girth enlargement on sexual relationship satisfaction, confidence, and self-esteem, and to evaluate the clinical efficacy and safety of this procedure for the management of men with small penis syndrome (SPS).

Methods

This was a single-center, clinical case series study executed from January 2019 to February 2021, which involved 148 men who were unsatisfied with the shape of their normal-size penises and requested penis girth correction.

Results

A total of 132 patients completed full treatment and follow-up. Mean girth enlargement was 1.7 ± 0.32 cm for the midshaft and 1.5 ± 0.32 cm for the glans of the penis. Satisfaction with sexual life improved. Mean scores increased by 17.9 ± 3.04 points for sexual relationship satisfaction and by 12.2 ± 3.17 points for confidence. The mean score for self-esteem increased by 8 ± 2.8 and by 4.3 ± 0.97 points for overall relationship satisfaction.

Conclusions

Penile enlargement with hyaluronic acid injection positively affects sexual relationship satisfaction, confidence, and self-esteem of men with SPS. The rate of psychosocial improvement does not correlate with penile size changes. It is a simple, safe, and effective technique that can be used in daily clinical practice.

Level of Evidence: 4

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In recent years aesthetic injection techniques with soft tissue fillers have become popular worldwide due to their effectiveness, safety, and low cost.¹ The demand for genital cosmetic procedures has grown as well. Historically, the male genital organ has been associated with fertility and sexual performance and considered the main factor of masculine identity.² The reason men seek penis enlargement is deeply linked with individual body perception.³ According to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), excessive preoccupation with one or more perceived defects or imperfections in physical appearance is defined as a somatoform disorder called body dysmorphic disorder (BDD); in the case of a negative perception of the shape or size of the penis, it is called penile dysmorphic disorder (PDD).⁴ This is a disorder that negatively affects the patient's daily life. The majority of these individuals report no change or even worsening of their BDD symptoms after an aesthetic treatment. For these reasons, there is a growing consensus that BDD contraindicates aesthetic treatment and should be referred to a mental health professional.^5,6 But in cases in which the degree of anxiety is not strong enough to comply with BDD (PDD) criteria, it is called small penis syndrome (SPS).⁷ Nevertheless, individuals with SPS experience the distress of impairment in social, sexual, and other areas of function.⁶ The latest treatment considerations are to reduce this distress. Currently, there is not enough evidence regarding the effectiveness of psychological intervention in men with SPS.^6,8 On the other hand, surgical methods of penile augmentation may be beneficial in some of these patients.^8-11

Today, aesthetic penile enlargement procedures are done mainly in private settings and at the demand of patients. There is no standard approach to the management and follow-up of patients seeking the penile enlargement procedures described in the literature, and the surgical penile enlargement methods are also controversial.^3,9,10,12-14 The main objective of the conducted study was to assess the effect of injection penile girth enlargement on the sexual relationship satisfaction, confidence, and self-esteem of men with SPS. Furthermore, the clinical efficacy and safety of this procedure for the management of SPS was evaluated.

METHODS

Patients and Study Design

This was a single-center, clinical case series study that was executed from January 2019 to February 2021, which involved 148 men who were unsatisfied with the shape of their normal-size penises and requested penis girth correction. The participants were enrolled in the study by the principal researcher. The manuscript is authorized for publication in open sources by the local Institutional Review Board of the State Institution of Science Research and Practical Center of Preventive and Clinical Medicine, Kiev, Ukraine. The study was also approved by the Ethics Committee. Relevant information about the procedure and possible complications was discussed before the intervention, and all patients signed the corresponding informed consent. All patients consented to the scientific use of their research data, with the exclusion of personal data.

Inclusion and Exclusion Criteria

The research included men from 21 to 60 years old who requested penile enhancement. The exclusion criteria were micropenis (individuals with a flaccid penis length of <4 cm and an erect penis length of <7.5 cm); other penis abnormalities (buried or trapped penis, etc); and conditions associated with length loss or “acquired short penis” secondary to a disease or an intervention (prostate surgery, prostate radiation, prostate cancer hormonal treatment, diabetes with severe penile atrophic damage, etc).¹⁵ Patients with erectile dysfunction (ED), PDD, and other severe psychiatric disorders were also excluded from the research.

All patients underwent injection penile girth enhancement with hyaluronic acid (HA) gel. The study was designed as a before-after investigation. Measurements and questionnaires were done before and 3 months after the procedure. Questionnaires were conducted on paper in the doctor's office, by the same doctor (Appendices A-F, available online at www.aestheticsurgeryjournal.com).

Questionnaires

The Cosmetic Procedure Screening Scale for PDD (COPS-P) is a 9-item validated questionnaire to determine whether a patient has PDD. The score scope of this questionnaire was 0-72 points. It was administered to detect patients with PDD and differentiate them from patients with SPS. Men with results of 40 or more were considered to have PDD; others were diagnosed with SPS, according to the original article.¹⁶

The International Index of Erectile Function (IIEF-5) was performed to evaluate the rate of ED. This was a 5-item questionnaire related to sexual activity during the last 6 months. Answers were rated from 1 to 5, with a scope of 5 to 25 points. Patients with a result of 22 points or more were considered to have normal erectile function.¹⁷

The Self-Esteem and Relationship (SEAR) questionnaire was given to evaluate patients with SPS for their level of distress in social, sexual, and other areas of function in the preprocedure and postprocedure periods. Patients completed this 14-item questionnaire before the treatment and 3 months after the treatment. The scale measured sexual relationship satisfaction, overall relationship satisfaction, confidence, and particularly self-esteem. Participants could score between 0 and 100 points (more points indicating less impairment). The scale was divided into 2 domains and the second domain had 2 subscales. The first domain was sexual relationship, and the second domain was confidence, with subscales for self-esteem and overall relationship. There was also an overall total score for the SEAR questionnaire.¹⁸

Measurements

The girth of the penis was considered its midshaft circumference and the glans of the penis girth was its circumference at the corona level, measured with a measuring tape.¹⁹ The same doctor took measurements of the penis in a flaccid state and in horizontal patient orientation at room temperature each time. Patients were in a calm state during the measurements.

Procedure Technique

The procedure was done under local anesthesia with topical lidocaine ointment and a dorsal penile block. A standard method was employed for all participants. Each patient was injected with 14 mL of cross-linked HA gel DeneB Classic-S (BioPlus, Seongnam, South Korea) in total: 10 mL in the shaft and 4 mL in the glans. For the shaft injection was performed with a 7-cm 22G cannula (Figure 1). It was inserted between the superficial and deep penile fascia through 2 punctures placed at 10 and 2 o’clock, 0.5 to 1 cm proximal of the corona. The hyaluronic gel was equally distributed on each side of the penis, avoiding the neurovascular bundle dorsally and the urethral area ventrally. The glans penis was augmented with multiple linear retrograde injections along the corona, then the other area was covered with fan-shaped injections (Figure 2).²⁰ An auto-adhesive bandage was applied after the procedure for 3 days to avoid filler migration. Patients were instructed to abstain from intercourse and masturbation for 1 week.

Statistical Analysis

The data of the study were analyzed with JASP Version 0.16.4 (JASP Team 2022, Amsterdam, the Netherlands). Pretreatment and posttreatment data were presented as a number, percentage, mean, standard deviation, median, minimum, and maximum. The Shapiro–Wilk test assessed suitability for normal distribution. For all quantities that had a normal distribution, a parametric method, the paired-sample t test, assessed the differences between the 2 arrays. In other cases, when samples were nonparametric, the Wilcoxon signed-rank test was employed. Correlation was tested with Spearman's rank correlation coefficient. The level of statistical significance was set at 5% (P < .05).

RESULTS

Demographic Data

The full analytic data set was collected from 132 patients (89.8%) of 148 patients enrolled in the study; 16 patients dropped out during the follow-up period. The follow-up period for all 132 patients was 3 months. The median age of the patients was 42 years, and the average age was 40. The youngest patient was 21 years old and the oldest was 57 years old (Table 1). All of them were sexually active; 87 (65.9%) had regular partnership sexual activity and 45 (34.1%) had irregular sexual activity.

Assessment of Measurements

The baseline mean midshaft girth of the flaccid penis was 9.5 ± 0.77 cm, with a glans of the penis girth of 9.7 ± 1.01 cm (Table 1). Three months after the procedure, the measures were 11.2 ± 0.84 cm and 11.2 ± 1.04 cm correspondingly (Figure 3). Mean girth enlargement was 1.7 ± 0.32 cm (17.9%) for the midshaft and 1.5 ± 0.32 cm (15.5%) for the glans of the penis. The values ​​were statistically significant (P < .001 on paired t test) (Table 2).

Assessment of SEAR Questionnaire

By evaluation with the SEAR questionnaire, patients’ satisfaction with their sexual life improved. The results with standard deviation bars are presented in Figure 4. Mean scores increased significantly for the sexual relationship domain, from a baseline of 41.7 ± 7.08 points to 59.6 ± 10.12 points (+42.9%) after the procedure. Mean scores of the confidence domain also increased from 28.5 ± 7.4 points to 40.7 ± 10.57 points (+42.8%) after the procedure. Similarly, the self-esteem subscale mean score increased from 18.6 ± 6.54 points at baseline to 26.5 ± 9.34 points (+43%) after the procedure; and the overall relationship subscale mean score increased from 10 ± 2.27 points at baseline to 14.2 ± 3.24 points (+43%) 3 months after the procedure. The mean total score of the questionnaire, which reflected the sum of the 2 domain scores, was 70.2 ± 12.51 points at baseline, rising to 84.2 ± 11.49 points (+19.9%) 3 months after the procedure. The values were statistically significant (P < .001 on the paired data on a Wilcoxon signed-rank test). As seen in Figure 4, there was significant improvement in each domain and subscale, leading to an improvement in the total score. The results are presented in Table 2.

Correlation Findings

We did not find a significant correlation between penile girth enlargement and the SEAR score increase (Table 3). The actual penis size increase affects psychosexual satisfaction as stated above, but the SEAR score does not rise correspondingly with the addition of each centimeter of girth.

Complications

No difficulties in sexual activity or functional problems were reported in the 3-month period after the procedure; IIEF-5 scores did not change. However, minor complications were documented. We registered 12 incidents (9%) of gel migration and nodule formation. In these cases, the penile shape was corrected by hyaluronidase injections into the areas of migration. There were 2 incidents (1.5%) of slight pain or discomfort in the penis that lasted up to 3 weeks. In all patients, physiologic reactions to the procedure such as edema and small subcutaneous hematomas on the glans occurred for a period not exceeding 2 weeks. No penile sensation impairment, neurovascular bundle injury, or infection at the sites of injection was observed.

DISCUSSION

Stereotypical ideals, a tendency to equate penis size with masculinity, and sexual competitiveness cause men to frequently request medical attention related to their genitalia.²¹ According to the majority of studies conducted over the last decade evaluating penile enhancement procedures in men with and without concomitant penile disorders, penile dimensions and deformities can be improved effectively with a high level of satisfaction and few major complications.^22-24 There is, however, a lack of internal validity in most cases when it comes to scientific evidence in the evaluation of the psychoemotional effect of penile aesthetic surgery. The latest studies in this area reported a high level of satisfaction utilizing different types of visual analog scales, assessing satisfaction from 0 to 5, 6, or 10, with higher numbers corresponding to greater satisfaction.^9,22-26 According to Jin et al, 96% of patients were satisfied with the result of penoplasty with the biodegradable scaffold Maxpol-T.²⁷ Kang et al reported a high level of satisfaction in more than 92% of participants after penile girth enhancement with autologous fat injection technique.²⁸ In the study of Kwak et al, up to 100% of the patients and their partners were satisfied or very satisfied with the result 18 months after a penis enlargement procedure with HA gel.²²

In spite of a certain complication rate in cosmetic penile enhancement surgery, studies do not comment on erectile dysfunction after procedures.²⁷ Furthermore, the evaluation of 355 patients after penile enhancement showed improvement in erectile function, with an increase in the IIEF-5 score of up to 6.74% compared to baseline.²⁹ This improvement may be related to the positive psychological effect of the procedure.

One of the main findings of our survey was that HA injection penile girth enhancement has a positive effect on the sexual relationship satisfaction, confidence, and self-esteem of men with SPS. The total score improvement on the SEAR questionnaire was 14 ± 4.67 (P < .001). Scores were 17.9 ± 3.04 for sexual relationship, 12.2 ± 3.17 for confidence, 8 ± 2.8 for self-esteem, and 4.3 ± 0.97 for overall relationship. We have not found any previous studies that assessed these variables after penile enhancement, but SEAR score changes were reported by other scientists for other types of genital surgery. There was a significant increase in the SEAR scores of patients after penile lengthening with ligamentolysis and correction of congenital penile deviation.^30–32 The most prominent improvement was in the categories of self-confidence and the sexual and overall relationship, similar to the results of our study.³¹

This research focused on a group of patients with SPS who underwent injection penile girth augmentation and utilized a validated scale (SEAR) for psychosexual satisfaction evaluation. But the most debatable question is whether such procedures have to be performed in patients with a normal-size penis who request penile enlargement. As of yet, there is no clear answer or follow-up recommendation.^3,7,9 The guidelines of the European Association of Urology also do not include an approach to the management of this condition.³³

Injection penile girth enlargement is a simple and commonly employed technique for penile girth enhancement that is considered an in-office procedure. It usually gives instant positive results.²⁵ This was not the only reason for the good results in this study; in addition, the positive results could be explained by the strict inclusion process and exclusion of patients with psychiatric disorders. This approach is strongly suggested by numerous scientists in this field.^3,7,9,25,34 On the other hand, a disadvantage of this method is the relatively short duration of the effects, due to the fast resorption of HA, which lasts around 12 to 16 months.¹¹ The hyaluronic acid manufacturer claims that the substance's volumizing effect lasts between 12 and 16 months; we have not conducted a long-term analysis of our own to verify this claim.

The outcome of penile girth enlargement primarily depends on the volume of the injected filler and the baseline size of the penis. There is a method for calculating future girth increase.³⁵ The penile shaft measurement results in this study were nearly equivalent to the measurements in similar studies. Kwak et al reported a girth increase from 7.48 cm to 11.41 cm with the use of 20 mL of filler.²² Similarly, Casaventes et al observed an increase from an average of 9.8 to 10.5 cm.²⁴

The safety of hyaluronic fillers is currently well-tested, and they are utilized for many procedures each year.^1,9-11 Our study was not an exception. The complication rate is low. The most common complication was gel migration and nodule formation.³⁶ The incidence of 9% in our study was similar to or lower than that in other studies.^11,37,38

Another interesting finding was that the degree of penis enlargement did not correlate with the increase in SEAR scores. This probably occurs because the positive psychoemotional effect is primarily related to the fact of penile augmentation, whereas the actual size and its changes are a secondary effect. Previous research has not shown that the type of applied operative technique has an effect on the level of satisfaction. A double-blind study that compared the effects of HA and polylactic acid filler injection after 48 weeks did not observe variation in levels of satisfaction with sexual life between the 2 groups. However, level of satisfaction with penile appearance was different.¹¹ In the general population, up to 68% of men prefer to have a larger penis, with no clear dependence on the actual size.³⁹ Therefore, we can hypothesize that the distress reduction mechanism of penile correction is similar to that of compulsive acts in BDD and other disorders of the obsessive-compulsive spectrum. Future studies are needed to clarify the mechanism of improvement in the psychoemotional state of patients with SPS after a penile enhancement procedure.

Regrettably, the COVID-19 pandemic and subsequent war in our country have disrupted data collection and analysis processes, making it difficult to obtain a complete picture of the outcomes for patients at 6 and 12 months after treatment, or the percentage of patients who return for repeat treatment or go on to have a more permanent surgical correction. The pandemic caused interruptions of scientific activities, patient follow-up appointments, and data analysis procedures. Additionally, the war has made it challenging to collect data from certain regions and populations affected by the conflict. These external factors had an impact on our ability to fully collect and analyze the data. Considering all this, we decided to limit data analysis to 3 months.

The novelty of the study lies in its detailed investigation of the impact of penis enlargement procedures on male sexual satisfaction, confidence, and self-esteem. Our findings provide valuable insight into the psychoemotional effects of this procedure, which may assist plastic surgery specialists as they evaluate and select patients for the treatment. Moreover, this research may be useful in further studies in the fields of aesthetic medicine, psychology, and psychiatry.

Although our study has contributed valuable insights into the investigated intervention, we recognize that there are several limitations that need to be considered. The first limitation of our study was the lack of comparison and control groups. Second, the short follow-up period may limit the ability to draw definitive conclusions about the long-term effects of the intervention. Third, not all initially enrolled participants completed the study. The final limitation is that the SEAR questionnaire was translated by a professional translator with the participation of a psychologist; we acknowledge the need for further validation studies of the localized version of the questionnaire. Nonetheless, we believe that our study’s findings provide a helpful starting point for future research endeavors in this area.

CONCLUSION

Penile enlargement with HA injection has a significant positive effect on sexual relationship satisfaction, confidence, and self-esteem of men with SPS. However, the rate of psychosocial improvement does not correlate with penile size changes, which means that patients benefit from the single fact of enlargement, not the actual measurable girth gain. It is a simple, safe, and effective technique that can be utilized in daily clinical practice. Future studies are needed to better understand the effects of penile enhancement on the psychoemotional state of SPS patients.

Supplemental Material

This article contains supplemental material located online at www.aestheticsurgeryjournal.com.

Disclosures

The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The authors received no financial support for the research, authorship, and publication of this article.

REFERENCES

Author notes