Safety and Efficacy of the PrePex Device for Rapid Scale-up of Male Circumcision for HIV Prevention in Resource-limited Settings

Jean Paul Bitega, MD, MMed (Surgery); Muyenzi Leon Ngeruka, MD; Theobald Hategekimana, MD; Anita Asiimwe, MD, MPH; Agnes Binagwaho, MD, PhD

Disclosures

J Acquir Immune Defic Syndr. 2011;58(5):e127-e134. 

In This Article

Discussion

Prior studies with other products for adult male circumcision have reported advantages over conventional surgical circumcision, such as elimination of sutures and reduction in procedure time.[12–16] However, we believe that all of these other methods require injection of local anesthesia for device placement and/or removal and that our study is the first report of adult male circumcision as a public health initiative performed without anesthesia.

Another adult male circumcision device is the Shang Ring (Wuhu SNNDA Medical Treatment Appliance Technology Co Ltd, Wuhu, China). A 2011 report describes a 6-week study of this device in Kenya. Similar to the present study, device placement was on day 1 and removal was on day 7.[17] Of 40 procedures performed, all resulted in successful circumcision.

Both the Shang Ring and the PrePex device are single-use devices supplied in multiple sizes. The Shang Ring immediately crushes the foreskin and thus requires anesthesia (6–20 cc of 1% lidocaine without epinephrine, injected circumferentially around the penis) before placement; the PrePex device applies controlled radial elastic pressure and hence requires no anesthesia (though we found it helpful to provide 1 g of paracetamol to reduce discomfort postplacement). Use of the Shang Ring is a surgical procedure that requires a sterile setting because the live distal foreskin is removed immediately after placement of the device (in addition, 4 small incisions are made around the cut edge of the foreskin to minimize wound contraction and to limit pain from nocturnal erection[15]); use of the PrePex device is a nonsurgical procedure that can be performed in a standard consultation room because the distal foreskin is necrotic when removed, bloodlessly. Time for placement and removal of the Shang Ring averaged 4.8 and 3.9 minutes, respectively (total: 8.7 minutes), not counting time for anesthesia to be administered and to take effect; time for placement and removal of the PrePex device averaged 4.3 and 3.8 minutes (total: 8.1 minutes), and there was no need for anesthesia. There were 3 instances of partial detachment of the Shang Ring before removal; there were no mechanical incidents with the PrePex device. The Shang Ring was associated with 6 mild adverse events (3 cases of penile skin trauma, 2 of edema, and 1 of infection) in 40 subjects; the PrePex device was associated with 1 mild adverse event (diffuse edema in a man with chronic urethritis) in the 55 subjects in both phases of the study. In the Shang Ring study, 80% of the men returned to work within 2 days after device placement; in this study of the PrePex device, 100% of the men returned to work the day after device placement. Time to complete healing averaged 28.9 days with the Shang Ring and 25.3 days after removal of the PrePex device (ie, 32 days after placement). In a separate report on 328 Chinese men circumcised with the Shang Ring, major complications included infection (0.6%), bleeding (0.6%), wound dehiscence (0.6%), and edema (4.9%).[15]

The success of any public program encouraging adult circumcision depends on acceptability by candidates for the procedure. The large number of unsolicited volunteers who approached us before and during the study suggests adequate acceptability within the target population. Several subjects spontaneously expressed satisfaction with the procedure during the course of the study, and some said that they would recommend it to others.

Concerning the exclusion of men with phimosis, the present study was designed to assess a nonsurgical procedure for rapid scale-up programs in Sub-Saharan Africa; men with phimosis might be circumcised with the PrePex device after a small slit in the foreskin, as has been done with other devices, although that added step would transform the procedure from nonsurgical to surgical; future studies may explore this option. The true prevalence of phimosis is uncertain. In a study of 351 boys and men circumcised with the Shang Ring, 46 (13%) had phimosis,[18] whereas among 81 screened candidates in the present study, 4 (5%) were excluded (2 during screening, 2 after admission) because of phimosis. According to a report from the British Association of Paediatric Urologists, 5% of boys ages 16–17 still have nonretractible foreskin.[19]

Healing and Adverse Events

The average time for complete healing after surgical circumcision in adult males is 4–6 weeks.[10] In our study with the PrePex device, mean time to complete healing was 25.3 days after foreskin removal or 32 days after device placement, which is within the same range, and is similar to healing time with the Shang Ring.

Reported problems associated with surgical circumcision include postoperative bleeding, wound infection, anesthesia-related complications, and edema.[20] With the PrePex device, localized edema is an expected occurrence during healing. Edema incidence rates of 50%[12] and 14%[13] have been reported with other ring devices. In our study, all cases of localized edema (9 of 50 subjects) occurred after device removal and resolved spontaneously. There were no adverse events while the device was in place. The only reported adverse event after removal was the case of diffuse edema in a subject with chronic urethritis.

Foreskin Removal

During the initial phase of the study, self-detachment of the foreskin was explored but ruled out as unpredictable and impractical (although the experience suggested that there would be no acute danger if a man missed his scheduled visit for active removal). Accordingly, in the main phase, active removal of the foreskin and the device was a scheduled procedure, which took place on day 4 in the first 5 subjects and on day 7 in the remaining 45 subjects, to allow time for the foreskin to become more completely necrotic for bloodless removal with scissors. We noted no differences in outcomes related to removal on day 4 versus day 7.

Infection and Bleeding

There were no cases of infection or outright bleeding with the PrePex device, but 2 subjects had light, transient oozing after foreskin and device removal (stopped by local compression with gauze for 10 seconds). From various reports on the Shang Ring, the incidence of infection was 0.6%–2.5%, and the incidence of bleeding was 0.0%–0.6%.[12,15,17,18] From a systematic review of published reports of nontherapeutic surgical circumcision in men, the 2 most common adverse events were infection (incidence 1.47%) and postoperative bleeding (1.32%).[20]

Pain

Because we noted that several of the first 20 subjects in the main phase experienced pain after placement and/or during removal of the device, we thereafter provided a 1-g dose of oral paracetamol 30 minutes before placement and before removal; no additional painkiller was required in any subject at any time. Subjects reported minimal pain at all other times. Paracetamol reduced postplacement discomfort but not the brief pain subjects experienced during removal of the inner ring. Circumcision using the Shang Ring requires injection of local anesthetic around the penis.[15,17]

We recommend that in future studies, VAS pain score should be checked earlier after device placement (in the present study, we checked 3–6 hours after placement). We now believe that ibuprofen administered immediately after placement may be a better means of managing discomfort at this step.

Among the 50 subjects in the main phase of our study, 10 reported minor discomfort with nocturnal erection while the PrePex device was in place, but this experience was not objectively measured. The need for a standardized means of assessing pain from nocturnal erection is suggested by contrasting the 20% incidence of pain on erection reported in the present study and the 86% incidence reported in one study of the Shang Ring.[12]

Procedure Time

As the team gained experience, procedure time decreased. We anticipate that total procedure time would be less than 5 minutes when performed by experienced personnel. Total procedure time is marginally lower with the PrePex device than with the Shang Ring (8.1 versus 8.7 minutes), but anesthesia adds to the overall time required with the Shang Ring. In various reports, the time required for conventional surgical circumcision is 25–36 minutes.[16,21,22]

Topical Agents and Dressings

We used vaseline as a lubricant on the penis to ease insertion of the PrePex inner ring. In retrospect, we would recommend a water-based lubricant applied only on the Inner Ring itself.

After removal of the foreskin and the device, we covered the remnant of necrotic tissue with antibiotic cream and gauze dressing to reduce the risk of wound infection. In fact, there were no infections, and we suspect that there is no need for antibiotic cream; this question will be explored in future studies. An alternative would be a vaseline gauze dressing (as currently used in surgical circumcision) or a standard gauze dressing.

Staff and Facility Requirements

Circumcision using the PrePex device requires 2 trained staff members for device placement; both can be nurses, and at least 1 should have ample dexterity. Device removal requires 1 person with ample dexterity. Although most of the procedures were handled by physicians, we noted no differences in procedure time, pain, adverse events, or healing time related to whether procedures were performed by a nurse or a physician. Further study is warranted to document the feasibility of entrusting the procedure to nurses, but these preliminary results are encouraging and potentially important for large-scale male circumcision programs in Sub-Saharan Africa.

The main phase of our study was conducted in a standard consultation room. Aside from savings in costs and resource use from foregoing the sterile setting, men may feel less intimidated in a consultation room.

Costs

Binagwaho et al[23] have demonstrated that adult male circumcision is cost-effective even in regions with a relatively low HIV prevalence, such as Rwanda. Although there was no formal assessment of costs in this study, the use of the PrePex device may reduce costs, as the procedures can be performed by nonphysician staff, without anesthesia or suturing, in an ordinary consultation room. In the main phase of our study, none of the subjects missed any days of work after placement or removal of the device, which is relevant in a national scale-up program.

Study Limitations

Although we tried to select subjects with a more flexible foreskin, there was no validated method for assessing candidates on this basis. Also, we performed no methodical assessment of discomfort from erection while the PrePex device was in place; we recommend that future studies should obtain VAS pain scores during erection if subjects are cooperative. We did not formally analyze costs with the PrePex device versus other methods of circumcision, nor did we formally assess subjects' overall level of satisfaction with the procedure.

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