Male circumcision (MC) is a surgical procedure that has been performed over centuries for reasons including, but not limited to, medical, religious, cultural, and social causes.1 The benefits of circumcision were highlighted, including reduced risk of penile cancer, improved penile topical hygiene,2 and reduced risk of human immunodeficiency virus (HIV) infection.3-5
Various devices for adult MC were developed to improve safety and efficiency of the circumcision procedure, besides traditional ways described in WHO manual of male circumcision.6,7 Shang Ring has been introduced in our previous study, showing the safe application of the device.8
Shang Ring is manufactured by Wuhu Snnda Medical Treatment Appliance Technology Co, Ltd, Wuhu City, China. The Shang Ring consists of two centric plastic rings (inner and outer rings), plus medical-grade soft silicone pad lines on the surface of the inner ring, leaving a smooth, non-bioreactive surface against the penile skin and wound for potential wound bleeding controls. The outer ring consists of two halves that are hinged together at one end and containing a unique locking clasp on the other (Figure 1). These rings are positioned to sandwich the foreskin of the penis, allowing it to be excised without stitches or significant bleeding, and are then left in place for 7-10 days before being removed.
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Figure 1.:
The device of Shang Ring. The Shang Ring is composed of two concentric rings: an inner ring and an outer ring.
Large sample studies from China have shown the safety and effectiveness of Shang Ring MC.9,10 Data from Africa correlates well with the result from China, displaying the satisfactory application of the device and high acceptability in patients.11,12 Compared with traditional circumcision, Shang Ring MC has been demonstrated to be a safe procedure, with shorter operative time, less blood loss,13 and lower postoperative complication rate.14
However, encouraging results are mainly short term, and several uncertainties about Shang Ring MC still exist. The mechanism of the wound healing with Shang Ring MC is quite different from that of traditional ways. The uniform force from compression of rings results in ischemic necrosis of the tissues sandwiched between the inner and outer rings through the soft silicone pad, which allows a reliable bleeding control and promotes spontaneous anastomosis of the incised rim without crashing the tissue completely. But, there is a great disadvantage: because the edge of the surgical wound is in the front of the ring crashing point on the foreskin, which creates a relatively ischemic skin edge or necrosis zone in front of the rings wound healing process lasts for 20 days or even more,9,15 which is much longer than the traditional ways with sutures.14 Moreover, whether a future impact of the delayed recovery and ischemic tissue would occur remains unknown.
As a relatively new device, the report of Shang Ring MC has been no earlier than the year of 2008.8 Though the short-term follow-up result is promising as described above, there is still a lack of long-term safety and efficacy results about Shang Ring MC. In this retrospective study, we investigated the long-term result of patients who had undergone Shang Ring MC. To the best of our knowledge, no evidence-based data has been declared on this field previously.
METHODS
Patients
The principle of the Declaration of Helsinki was followed. The study was performed in the Department of Urology, Ningbo First Hospital, from 2009 to 2012. The enrollment criteria included patients with complete preoperative information and being willing to participate in the study.
All the patients in this study had filled in a questionnaire inquiring the condition of penis as well as their sexual life, for example, marriage status, intercourse frequency, men's and their partners' overall satisfaction in sexual life before the surgery. In the questionnaire, the satisfaction level toward sexual life was rated using a 10-point system, with 0 meaning most dissatisfied, 5 meaning indifferent, and 10 meaning most satisfied. Intra-vaginal latency ejaculatory time (IVELT) was inquired to evaluate ejaculation condition (patients were recommended to use a watch). The Brief Male Sexual Function Inventory (BMSFI) was used to evaluate participants' sexual function, consisting of sexual drive, erection, ejaculation, problem assessment, and overall satisfaction sections.
Participants all had Shang Ring MC in the Department of Urology, Ningbo First Hospital. The MC procedure was standardized according to the procedure described as reported.9 All surgeries were performed under local anesthesia (lidocaine 2%), which involved a dorsal penile nerve block with a ring block. When the anesthesia was achieved, the inner ring was placed around the penis to the level of the coronal sulcus. The edges of the foreskin were grasped with clamps at the 3, 6, 9, and 12 o'clock positions. The foreskin was flipped over the inner ring. In case of phimosis or a relatively tight foreskin opening, a dorsal slit was first made followed by eversion of the foreskin over the inner ring. The outer ring was then applied on the fold of the skin that covers the inner ring. After adjustment of the prepuce to remain, the outer ring was then completely clamped shut. A pair of curved tissue scissors was used to excise the excessive foreskin. Four to eight cuts are made in the foreskin on the underside of the ring using a scalpel blade. The removal procedure was done on the eighth postoperative day in accordance with the standard procedure:9 place the lock opener into the hole located on the outer ring and pry inward to open the lock. The outer ring was then removed gently. The inner ring was then separated from the wound margin, using curved scissors.
Follow-up and data collection
In order to gain the long-term result, we interviewed the patients after obtaining their acceptance. All participants had face-to-face interview in our department. During the interview, physical examination of the external genitals was performed by an experienced urologist. Width of mucosa (from the coronal sulcus to the junction of mucosa and scar) and that of scar were measured with a ruler (precision to 1 mm). Complications were evaluated and recorded, if existing. Photos of penes were taken when the participants allowed.
A questionnaire similar to the preoperative one was filled up. IVELT was again inquired and the sexual performance was evaluated through BMSFI. The satisfaction level of patients toward Shang Ring MC was rated using a 10-point system: 0 meant most dissatisfied, 5 meant indifferent, and 10 meant most satisfied. Patients were then asked to provide their comments on Shang Ring MC: what were the benefits of the surgery and what point they believed should be improved.
Statistical analysis
T-test was used to compare IVELT between preoperative and postoperative conditions. We used the nonparametric Mann-Whitney test to compare sexual frequency, satisfaction, and BMSFI. All the statistical analyses were performed using a statistical software package (SPSS 16.0, USA). Statistical significance was defined as P <0.05 and all P values were two-sided.
RESULTS
Basic characteristics of the patients
As Table 1 shows, a total of 103 patients were enrolled and finished the follow-up in this study. The follow-up duration at the time of analysis was (19.1±5.4) months (range from 9 to 28 months). The age was (28.4±4.7) years (20-40 years). Almost half the participants had completed college education. Though 21/103 (20.4%) patients were unmarried, most of them (98/103, 95.1%) had intercourse and their sexual behavior was evaluated. While 56 (54.4%) patients had smoking, 47 (45.6%) had alcohol drinking. A total of 14 (13.6%) patients had phimosis, with the rest 89 (86.4%) having abundant foreskin. By questionnaire as well as physical examination, no participants were detected to have erection problem or acute posthitis, balanitis, or sexually transmitted diseases.
Table 1: The basic characteristics of 103 patients
The cosmetic results and complications
During the face-to-face interview, physical examination of external genitals was performed and complications were evaluated. The mean width of mucosa was (9.3±2.5) mm. The mean width of scar was (3.7±1.6) mm. No tender pain was found in participants when palpating the penis. No significant complication was observed. Complications included mucosa asymmetry in one case and scar hyperplasia in two cases. However, cases with those complications did not complain damaged intercourse.
Effects on sexual function
In total, 98 patients (95.1%) had intercourse and their sexual behavior and function were evaluated (Table 2). The median preoperative sex frequency was 6 times per month, compared with 8 times per month for postoperative sex frequency (P=0.009). The median score for male satisfaction toward preoperative sex was 7, and that toward postoperative sex was 7.5 (P=0.319). However, in terms of median score of partner satisfaction, the postoperative result was better than the preoperative one (7 vs. 8, P=0.001). The differences in the mean BMSFI scores were not statistically significant in any of the five sections. Besides, the preoperative ejaculatory latency time was (8.8±5.1) minutes, compared with postoperative ejaculatory latency time of (9.3±4.0) minutes (P=0.474).
Table 2: Evaluation of sexual life in men and their partners
One case reported slight erection pain during the interview. He had no such pain preoperatively. Physical examination did not show any abnormality. When we watched the BMSFI, however, he responded with little impact on sexual life, with BMSFI 29 both preoperatively and postoperatively. No treatment was given to the patient.
Feedback from patients
The satisfaction level of patients toward Shang Ring MC was rated using a 10-point system. The median satisfaction score toward Shang Ring MC was 8 (range 5-10). Patients were then asked to provide their comments on Shang Ring MC: what were the benefits of the surgery and what point they believed should be improved. While 43 patients mentioned hygiene as the benefit that Shang Ring surgery had brought to them, 28 pointed that the surgery was beneficial for sexual life. As for defects of the surgery, 15 patients considered the postoperative pain should be relieved. Another 23 cases supposed that the healing process took too long and the problem should be appropriately solved. Other people did not give specific comments on defects.
DISCUSSION
It is estimated that millions of adult MC will be required over the next 5-10 years to effectively slow the spread of HIV.16 MC is now wildly acknowledged as a prevention method efficacious in reducing HIV risk.17,18
Shang Ring MC was invented in and originated from China. It is one of the few adult MC devices that have been studied in large populations. In the short-term follow-up, the advantages of Shang Ring have been revealed in previous reports, including short operative time and low volume of blood loss.9,12-15
However, as a relatively new device and method, data for the long-term follow-up of Shang Ring is still lacking. The wound healing mechanism and the process of Shang Ring are very different from the traditional MC with suturing technique. The ischemic wound and prolonged wound recovery are factors that are of concern. Previous studies focused on the safety, feasibility, acceptability, and satisfaction of the Shang Ring MC. No long-term follow-up studies for wound healing or cosmetic results have been done except the short-term results of 1 month when the patients still had no intercourse. Whether the 7-10 days' wearing of Shang Ring as well as the prolonged healing time would have a delayed impact on cosmetic result or sexual function remains unknown or is continuously debated. In this study, we conducted an investigation into the long-term study up to 28 months of the cosmetic result of Shang Ring MC.
In this study, generally, patients who underwent Shang Ring MC had good cosmetic result of penes. The width of mucosa was acceptable and scar tissue had healed properly. As we know, conventional circumcision may represent late complications including epidermal inclusion cysts, suture sinus tracts, inadequate skin removal resulting in redundant foreskin, penile adhesions, urethrocutaneous fistulae, and meatal stenosis.19 In our study, we detected the late complications of Shang Ring MC. The most commonly observed complications were grade I: mucosa asymmetry and scar hyperplasia. Because those did not hamper sexual life, we did not treat them. No significant complication was observed. We suppose the relatively low complication rate is due to the unique course of Shang Ring MC: the coronal sulcus is visible throughout the procedure, minimizing the risk of injury to the glans and making it easy to perform and control the mucosa to maintain. However, for Shang Ring MC, we still believe it is a must to insist on the contraindication of MC to reduce the risk of complications. And though Shang Ring MC is characterized by its simplicity, health providers should always be cautious during the surgery so that the foreskin removal is symmetrical.
Circumcision has been debated for decades as to its effect on sexual function. Some studies in recent literature do not indicate any effects on male sexual satisfaction.20,21 However, it is reported that uncircumcised men have more sexual pleasure than circumcised men,22 while Namavar et al23 found that removal of foreskin may lead to better control over ejaculation.
In this study, we evaluated IVELT and BMSFI as a measure of sexual function. No patients had erection problem after the surgery. No statistical difference was found in sexual drive, erection, ejaculation, problem assessment, or overall satisfaction, as measured by BMSFI. Besides, the mean ejaculatory latency time did not show statistical difference after circumcision. Our result correlates well with the report from Kigozi et al.24
Participants did not show any improvement in satisfaction toward sexual life, while their partners were more satisfied with the intercourse. In our opinion, that partners were more satisfied may probably be related to more frequent intercourses. However, it could also be a result of placebo effects. We guess a controlled study with a larger sample would be required to determine the effect of circumcision on sexual function and pleasure. In general, our findings suggest that Shang Ring MC, as a new method, has no deleterious effect on sexual function at least.
Though the surgery has shown advantages, most of them were medical, like shorter operative time, less blood loss, and low complications, as we have mentioned. We are glad to know what the patients believe, which may greatly help us in improving the technique and services. Participants responded with a high satisfaction, which is consistent with our previous reports.9,14 In this study, an open question was given to the participants. Hygiene was considered as the most significant benefit of Shang Ring MC. Circumcision has been proved to reduce the risk of infection of bacteria as well as viruses like HIV and human papillomavirus (HPV),25,26 which is now acknowledged as a remarkable advantage of MC by the public. Improvement of sexual life was considered to be the second significant benefit, as participants proposed. We suppose it may be due to placebo effects.
In terms of weaknesses of the surgery, long healing time seemed to be the key point. In order to quicken the healing time, improvements to the device are needed urgently. Together with this, improvements in techniques may minimize the disadvantages of Shang Ring MC.15 Postoperative pain was also proposed as a weakness of Shang Ring MC. Postoperative pain mainly occurred at night and during ring removal. Though pain measured by the visual analog scale seemed to be slight and tolerable,12,14 we presume it would damage the life quality when wearing the ring and finally decrease the acceptability of patients to the surgery. Likewise, more investigations would be required to explore ways to minimize the pain through either improvement of techniques or application of medicine.
There are still deficiencies in this study. First, we did not detect the infection rate of organisms like HPV, mycoplasma, or Chlamydia; thus the reduction of infection remains unknown. Second, we suppose a larger sample of patients needs to be enrolled for a longer follow-up schedule. In that case, an all-around evaluation of Shang Ring surgery can be obtained.
In general, in the long-term follow-up, Shang Ring MC represents a good cosmetic result with no significant complication. Shang Ring MC at least does not bring adverse effects on sexual function. Patients have good acceptability. Shang Ring circumcision is worthwhile to be popularized. However, efforts need to be made to reduce postoperative pain and shorten healing duration.
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