As used in this monograph, the term "condom failure" refers to breakage or complete slippage of the device, either of which can result in leakage of bodily fluids. Condom failure may or may not result in pregnancy or disease transmission. Condom failure refers only to what happens to the device, not to the consequences of the failure.
Condom breakage can be in the form of a burst, rip or tear, which may occur at the tip, along the shaft or near the opening of the condom. Breakage can occur while opening the condom package, putting the condom on the penis, during intercourse, withdrawing the penis, or removing the condom.
Slippage may be partial or complete. During partial slippage, part or all of the condom slips down the shaft of the penis. Partial slippage can also happen in the form of tip displacement, in which case the closed end of the condom is no longer held tightly around the end of the penis. For complete slippage to occur, the condom must become separated from the penis. Slippage can occur during intercourse or withdrawal.
Researchers have gathered data on condom failure during human use in a variety of different ways, making comparisons across studies difficult. To address this problem, standardized definitions of condom failure and minimum standards for data collection and presentation have been proposed. (Steiner) The proposed standard definitions of condom failure are summarized below.
- Nonclinical breakage rate -- number of condoms reported to have broken while opening the package or putting on the condom divided by the number opened.
- Clinical breakage rate -- number of condoms reported to have broken during intercourse or withdrawal divided by the number of condoms used during intercourse.
- Total breakage rate -- number of condoms reported to have broken (nonclinical and clinical) divided by the number of condoms opened.
- Complete slippage rate -- number of condoms reported to have slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used during intercourse (if participants report a clinical break and a complete slip, only the clinical break is counted).
- Total clinical failure rate -- number of condoms reported to have broken during intercourse or withdrawal, or slipped off completely divided by the number used during intercourse.
- Total failure rate -- number of condoms that have broken (nonclinical and clinical) or slipped off completely divided by the number opened.
In addition to the types of failure outlined above, data on breakage during removal of the condom from the penis and partial slippage should be reported as well. Moreover, data collected on the location of breakage may be useful information for manufactures to consider when designing new condoms.
by Alan B. Spruyt
Reference
Steiner M, Trussell J, Glover L, et al. Standardized protocols for condom breakage and slippage trials: a proposal. Am J Public Health 1994;84(12):1897-1900.
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