| | Condom—The need for predictable contraceptionSexual activity is one of the most common and simplest of human functions. The sexual mindset for men and women, once they have consented, is to have sex unencumbered and free. However, given the realities of unwanted pregnancies and sexually transmitted diseases (including the AIDS virus), couples—especially non-monogamous ones—need protection.
▪Couples want safe, protected, unencumbered sex.
▪Condoms provide a barrier to known pathogens when used properly, and they provide excellent contraception.
▪A small percentage of men (2%–5%) break or cause their condoms to slip, resulting in loss of sexual experience or loss of protection
▪New condom applicators allow full-proof and quick donning of condoms.
▪Air-infusion condoms can be used by those men with primary or secondary erectile dysfunction
We evaluated three devices, which were designed to unencumber the sex act and to eliminate/ameliorate those behavioral components thought to be the most troubling and interruptive.
The research studies described below focused on the following devices: 1) condom applicators, ie, devices that permit male condoms to be more easily donned; 2) erectile support condoms, ie, devices that maintain erectile performance; and 3) flaccid/semi-erect penis supports, ie, devices that permit intercourse without erections.
The studies described responses from 942 demographically representative males and females involved in a total of 5161 at-home clinical trials of vaginal intercourse. Each participant answered 90 questions modified only by product name. Each of the studies was part of research conducted under peer-reviewed, Institutional Review Board (IRB)-sanctioned, Office of Human Research Protections (OHRP)-controlled grants from the National Institutes of Health's (NIH) Small Business Innovative Research (SBIR) program. The research was designed so that participants randomly alternated the treatments (condom applicator/plain condom, air-infused device/plain condom) over ten at-home sexual episodes of vaginal intercourse.
Past condom research  Male condoms Male condoms as a form of barrier contraception have been shown in vitro to be impermeable to virtually all sexually transmitted organisms studied.1 Since they prevent fluid exchange and provide a complete barrier between the penis and the vaginal wall and cervix, male condoms are considered the most effective method of barrier protection against sexually transmitted infections (STI). Condoms help prevent pelvic inflammatory disease (PID), hence infertility, as well as ectopic pregnancy.2 Condom breakage rates in the US ranged from 2% to 5% according to one report.3 This along with slippage appeared to occur with significant frequency among those men with: no condom experience in the last year, condom breakage in the last year, not living with his partner, and having 12 or fewer years of schooling. Female condoms The female condom holds the potential for consistent use because the method is controlled by women. The female condom allows for insertion prior to sexual activity, hence women are not subject to the same performance dilemmas men are with the male condom. Several studies have indicated that barrier methods women control may be more often used than the male condom and, therefore, more effective in preventing STI transmission.4, 5 One study found that women who used the sponge or diaphragm had a lower incidence of trichomoniasis and gonorrhea than those using condoms. The CDC recently reported that spermicides may increase the risk for HIV sexual transmission by contributing to irritations caused during intercourse. Sponges, diaphragms, and cervical caps also provide a less substantial barrier than latex, as well as incomplete coverage of the exposed vaginal wall or vulva. The only efficient method of barrier protection that overcomes such problems is the female condom, since it protects the entire vaginal canal and area around the vaginal opening, plus it does not require the use of spermicide. Despite initial promising findings, there have been some contraindications to female condom use. Complaints about the female condom include: “It's noisy,” and “Its lubrication feels like Crisco.”6 One qualitative study of 71 heterosexual men reported that negative reactions centered on the ‘strangeness' and ‘bigness' of the female condom.5 Such results may be due to the contraceptive's newness and its lack of advertising. Additionally, one study found that female subjects, who did not have previous experience inserting a barrier contraceptive device, felt less comfortable inserting a female condom than those who had experience with such contraceptive devices. Condom applicator Condom applicators are classified by the FDA as medical devices and are ordinarily made from flexible plastic, to which a standard condom is pre-attached. When the condom is needed, they permit the always correct-way-on donning of that condom, using only one hand. See box titled “Clinical trials of condom applicators” on this page. Erectile dysfunction (ED) Erectile dysfunction, is defined as “the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.”7, 8 Erectile dysfunction prevalence is correlated, but not necessarily contingent on age, to include as many as 50% of men between 50–70 years of age.7 In one way or another, it affects 25%–30% of the adult male population. It is associated with diabetes mellitus,9 arteriosclerosis,10, 11 and is often a consequence of drug therapies designed to reduce blood pressure.7 Alone or in combination, these conditions either prevent muscles of the corpora cavernosa from relaxing, thereby impeding erectile-causing blood engorgement, or otherwise interrupt the sequence of physical events required to permit and sustain an erection. Erectile dysfunction is categorized as either primary (never able to sustain an erection) or secondary (previously able to sustain an erection) and can be transient, situational, or organically based, either due to natural or pathogenic sources.7, 12 Further classification refinement indicates that psychogenic has been applied to the transient subcategory when dysfunction is determined as stemming from psychological factors such as stress and performance anxiety.7, 13, 14 Organic factors have been subcategorized as under vasculogenic or neurogenic disorder or disease.7
Clinical trials of condom applicators
Study participants
429 participating couples reporting 3861 sexual episodes using donning applicators. Half were 21–39 years old; 54% were married; 71% were living with their partners. Median household income was $40,000–$50,000. 59% were European–American, 24% were African-American, and 15% were Hispanic. 96% completed at least a high school education.
Safety
The applicator technology reduced the amount of slippage and leakage and was equal to the plain condom with respect to breakage.
Satisfaction
The male respondents indicated that they were more sexually satisfied when using the applicator technology compared to using a plain condom conventionally.
Discussion
It was not the plain condom that resulted in the participants' scores of increased satisfaction, but rather the combination of the use of the applicator with the condom that produced the highest scores. Thus, with the condom being held as a constant, and with the same person donning the plain condom or the condom + applicator, the benefits created by the applicators provided the greater satisfaction. The process of donning itself was improved. The technology of the applicators expedited the donning process—essentially eliminating chance, fumbling, and error.
Clinical trials of erectile dysfunction technology
Objective
Determine the safe functioning of erectile dysfunction products Erectex™ and Levitron™. Actual efficiency was not measured.
Participants
A total of 340 clinical trials were conducted among 34 heterosexual couples and 10 other women who participated in medically supervised laboratory trials of simulated intercourse where they were internally examined colposcopically before and after their trials using Erectex.
Safety
No adverse events were reported related to the air-infused technology nor to either penile or vaginal tissue abrasion.
Satisfaction
The male participants who tested Erectex reported that the device enabled them to maintain their erections three times longer when compared to either a contoured conventional condom (which has a compressive effect) or no condom at all. The female respondents who used Levitron were significantly more satisfied and reached orgasm significantly more often compared to trials using the plain condom. In follow-up interviews, these females recalled that intercourse using Levitron was better than with no condom at all.
General results
Men who had been unable to produce an erection but who still had sensitivity indicated that the moment they donned and inflated Erectex its compressive chambers generated ‘the feeling' of an erection causing them to be psychologically stimulated toward quickly engaging in intercourse.
Discussion
The air-infusion principal is a reliable and safe means of supporting erectile functioning and generating increased sensitivity. Larger clinical trials to repeat and extend the current research have been planned. These studies will also include populations of heterosexual couples where the male partner is already diagnosed with a specific form erectile dysfunction and where said diagnosis is independently verified by study Urologists. Both the Erectex and the Levitron devices are undergoing substantial improvements, some of which were generated by the observations of test subjects.
The introduction of effective medications, (to treat testosterone imbalance or to reduce symptoms through vascular action), has brought relief to hundreds of thousands of afflicted men/couples.10, 11, 15, 16 One preparation, Viagra™ (Sidanafil-citrate), has been very newsworthy and, in private, it has been called the ‘young-again' drug. Recently, other oral PDE-5 inhibitors medications (Cialis™ and Levitra™), having similar or even increased ability to sustain erectile functioning, have been approved for prescriptive use by the FDA. Unfortunately, each of these vasoactive drugs, including Viagra, is contraindicated for many patients who also take forms of vasodilators in the nitroglycerin family. Viagra has been linked to myocardial infarction,6, 15 and all have been associated with another rare side effect, priapsis. Other devices are available to achieve penile support and are applied externally to the penis. These include: a penile pump used to enlarge the penis via an externally applied vacuum, which engorges blood, followed by the application of an occlusive penile-ring to impede venous drainage. There are rubberized sheaths that fit over, enclose, and support the penis, secure under the testicles by an attached strap; and thicker, condom-like, devices that require a penile-ring to sustain their effect. Most of these are reported as uncomfortable, inconvenient, irritating, embarrassing and, as a group, not very satisfactory.16 Alternative procedures, involving the surgical implantation of one of several types of penile prosthetic devices, do, in many cases, permit a semblance of satisfactory functioning. However, this is an expensive, hospital-stay-procedure and is relatively unpopular with men.7 Air-infusion technology The air infusion devices in our study use the effects of minute amounts of targeted air-pressure to provide lateral support and help maintain ambient blood supply to the penis. In the case of Erectex™, they permit a man to engage in coitus without any erection whatsoever. Men are able to use the Levitron™ device to assist in the maintenance of an erection with the concomitant effect of increasing the effective size of their penis, a benefit immediately felt by their partner (see box titled “Clinical trials of erectile dysfunction technology” on the previous page). Discussion On average, all participants in the clinical trials were paid an honorarium of $15 for each episode/clinical trial of intercourse. Therefore, it is possible that their answers and positive ratings of the devices being investigated were influenced by said payment. Only when the devices are made available as over-the-counter products can one actually determine their acceptance. No participant had ever seen or used devices like those tested in the clinical trials. The study technicians were careful not to discuss complaints normally associated with using conventional condoms. For many of the trials, only the same instructions for use as they would appear on a display box were given. Therefore, the results were as close as possible to those that might be achieved if someone gave one of the devices to one of their friends to try—not withstanding the $15 payment which would not ordinarily apply. In terms of this investigation of new methods of contraception combined with sexual enhancement, we were pleased with the initial results. References 1.
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a Condax LLC, New York, NY, NIMH Fellow, Harvard University b Feinstein Institute for Medical Research, North Shore–LIJ Health System, Manhasset, NY c Condax Medical Products LLC, New York, NY  Condax LLC, 40 East 89th Street, New York, NY 10028, NIMH Fellow, Harvard University
Feinstein Institute for Medical Research, North Shore–LIJ Health System, 1129 Northern Boulevard, Suite 302, Manhasset, NY 11030 Condax Medical Products LLC, 245 East 24th Street, New York, NY 10010 PII: S1546-2501(06)00029-6 doi:10.1016/j.sram.2006.08.010 © 2006 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. | |
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