Nonlatex versus latex male condoms for contraception

 

Abstract

Background

The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex.

Objectives

The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage and slippage, safety, and user preferences.

Search methods

We searched computerized databases for randomized controlled trials (RCTS) of nonlatex condoms (MEDLINE, CENTRAL, POPLINE, EMBASE, LILACS, ClinicalTrials.gov, ICTRP). We also wrote to the manufacturers of nonlatex condoms and known investigators to locate other trials not identified in our search.

Selection criteria

The review included RCTs that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom.

Data collection and analysis

We evaluated all titles and abstracts located in the literature searches for inclusion. Two authors independently extracted data from the identified studies. We analyzed data with RevMan. The Peto odds ratio (Peto OR) with 95% confidence interval (CI) was calculated for each outcome of contraceptive efficacy, condom breakage and slippage, discontinuation of use, safety, and user preference. Contraceptive efficacy, early discontinuation, and safety outcomes were also measured with survival analysis techniques.

Main results

While the eZ·on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in the typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. The nonlatex condoms had higher rates of clinical breakage than their latex comparison condoms: the Peto OR for clinical breakage ranged from 2.64 (95% CI 1.63 to 4.28) to 4.95 (95% CI 3.63 to 6.75). Few adverse events were reported. Substantial proportions of participants preferred the nonlatex condom or reported that they would recommend its use to others.

Authors' conclusions

Although the nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms, the new condoms still provide an acceptable alternative for those with allergies, sensitivities, or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of the nonlatex condoms requires more research.

 

Plain language summary

Nonlatex compared to latex male condoms for birth control

The male condom can prevent pregnancy by keeping sperm out of the birth canal. Nonlatex condoms can be used by people who are allergic or sensitive to latex. Some people may not have used latex condoms because they did not like them. This review compared nonlatex condoms with latex condoms. The main issues were effect on birth control, whether the condom broke or slipped, and which condom people liked.

We used a computer to find randomized trials of nonlatex condoms. We also wrote to researchers and makers of nonlatex condoms to find other trials. We included all studies that compared a male nonlatex condom with a latex condom.

The eZ·on condom did not prevent pregnancy as well as latex condoms. The Avanti and the Standard Tactylon condoms were similar to latex condoms for birth control. The nonlatex condoms broke more often than the latex condoms. However, many people liked the nonlatex condoms better. They may be useful for people who are allergic or sensitive to latex.

 

摘要

背景

非乳膠與乳膠男性保險套用於避孕

男性保險套是以很薄的套子覆蓋在龜頭和陰莖，男性保險套在性交時提供物理障礙，防止精液進入陰道，預防懷孕。非乳膠男性保險套始於1990年代，由聚氨酯薄膜或合成彈性體所組成,作為過敏,敏感或不喜歡使用乳膠保險套的男性之避孕選擇.

目標

此篇回顧比較以及評估非乳膠與乳膠男性保險套.評估的項目包括避孕效力、是否會破損、滑動、安全性和使用者的偏好。

搜尋策略

搜尋電子資料庫,尋找關於非乳膠保險套的隨機對照試驗.並寫信給非乳膠保險套廠商和知名學者找出其他沒有加以發現的試驗.

選擇標準

納入所有文獻中找到的隨機對照試驗,評估以聚氨酯薄膜或合成彈性體為原料的非乳膠男性保險套,與乳膠保險套的差異.

資料收集與分析

評估標題和摘要是否符合納入條件.兩作者獨立擷取試驗資料.採RevMan 分析.依據避孕療效, 是否會破損、滑動、停用率、安全性和使用者的偏好各結果變項的Peto OR和95% 信賴區間. 避孕療效, 提早退出試驗和安全性結果變項也以存活統計分析.

主要結論

雖然eZon 保險套的避孕效果不如乳膠保險套,但正常使用下, Avanti,標準Tactylon和同種乳膠保險套的避孕效果沒有差別.非乳膠保險套的臨床破裂率顯著高於乳膠保險套(Peto OR 範圍為2.6 (95% CI 1.6至 4.3)−5.0 (95% CI 3.6至6.8).沒什麼不良反應的紀錄.有顯著較多的受試者偏好或較推荐別人使用非乳膠保險套.

作者結論

雖然非乳膠保險套的臨床破裂率顯著較乳膠保險套高,這種新式保險套仍是過敏,敏感或不喜歡使用乳膠保險套的男性可接受的替代品.非乳膠保險套的避孕效果需要更多研究

翻譯人

本摘要由成功大學附設醫院尹子真翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

非乳膠與乳膠男性保險套用於避孕 男性保險套防止精液進入陰道，預防懷孕。非乳膠男性保險套可供過敏,或對乳膠敏感的男性使用.有些人因為不喜歡,所以不使用乳膠保險套. 本回顧比較非乳膠與乳膠男性保險套. 主要評估項目包括避孕效力、是否會破損、滑動和使用者的喜好。以電腦搜尋關於非乳膠保險套的隨機對照試驗.並寫信給非乳膠保險套廠商和知名學者找出其他沒有發表的試驗.納入所有文獻中比較非乳膠和乳膠男性保險套的隨機對照試驗. 雖然eZon 保險套避孕效果不如乳膠保險套,但正常使用下, Avanti,標準Tactylon和同種乳膠保險套的避孕效果沒有差別.非乳膠保險套的臨床破裂率顯著高於乳膠保險套.較多受試者偏好非乳膠保險套.非乳膠保險套可幫助對乳膠過敏和敏感的人