Sponge versus diaphragm for contraception: a Cochrane review.

The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and it does not require fitting or a prescription from a physician. We conducted a systematic review of randomized controlled trials that compared the vaginal contraceptive sponge with the diaphragm used with a spermicide in order to evaluate the efficacy and continuation rates of the two devices. The sponge was statistically significantly less effective in preventing overall pregnancy than was the diaphragm in the two trials that met our inclusion criteria. The 12-month cumulative life table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger US trial, and 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm [odds ratio 1.3; 95% confidence interval (CI) 1.1-1.6]. Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two trials. Other randomized controlled trials will be needed to resolve the role of spermicides in preventing sexually transmitted infections or in causing adverse effects.

Sponge versus diaphragm for contraception.

BACKGROUND: The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. The sponge, made of polyurethane impregnated with nonoxynol-9 (1g), releases 125 mg of the spermicide over 24 h of use. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and the sponge does not require fitting or a prescription from a physician. How the sponge compares with the diaphragm in terms of efficacy and continuation is not clear. OBJECTIVES: To compare the efficacy and continuation rates of the sponge compared with the diaphragm (used with nonoxynol-9 as a spermicide). Our a priori hypothesis was that the sponge would have a higher failure rate and higher discontinuation rates than the diaphragm. SEARCH STRATEGY: We searched the computerized databases MEDLINE, EMBASE, Popline, LILACS, and the Cochrane Controlled Trials Register. In addition, we searched the reference lists of all potentially relevant articles and book chapters. We also contacted investigators involved with both trials identified to seek other published or unpublished trials. SELECTION CRITERIA: We included randomized controlled trials comparing the vaginal contraceptive sponge (Today; Collatex) with any diaphragm used with nonoxynol-9 to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies identified through the literature searches for possible inclusion and evaluated their methodological quality using the Cochrane guidelines. We contacted an author involved with both published trials for supplementary information about randomization and allocation concealment. We entered data into RevMan 4.1 and calculated Peto odds ratios for overall pregnancy and 12-month discontinuation using numbers of women as the denominator. We also abstracted 12-month cumulative life-table ratios for these same outcomes, but were unable to aggregate these data. MAIN RESULTS: The sponge was statistically significantly less effective in both trials in preventing overall pregnancy than was the diaphragm. The 12-month cumulative life-table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger U.S. trial and 24.5 for the sponge and 10.9 for the diaphragm in the U.K. trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm (odds ratio 1.3; 95% CI 1.1-1.6). Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two trials. REVIEWER'S CONCLUSIONS: The sponge was less effective than the diaphragm in preventing pregnancy. Discontinuation rates were higher at 12 months as well. Other randomized controlled trials will be needed to resolve the role of spermicides in preventing sexually transmitted infections or in causing adverse effects.

Condom use during a community intervention trial in Kenya.

We conducted a cluster-randomized community intervention trial at Kenyan agricultural sites to measure the impact of female condom introduction on sexually transmitted infection (STI) prevalence. We present male and female condom use data here. Six Intervention sites received a community risk-reduction campaign and distribution of female condoms and male condoms, while 6 Control sites received the same campaign with male condoms only. Male and female condom distribution increased throughout follow-up. Self-reported male condom use increased substantially during follow-up to over 60% of the participants. The proportion of consistent male condom users at Control sites was higher than at Intervention sites, 23% vs 14% at 6 months and 24% vs 22% at 12 months. At Intervention sites, 11% and 7% of women used the female condoms all the time at 6 and 12 months, respectively, while the percentage of female condom non-users grew. Male and female condom use was hindered by male partner objections; suspicion of the study and the devices among residents; and bias against condoms by clinic service providers. A large proportion of coital acts remained unprotected during the trial. Our female condom intervention did not reduce STI prevalence, compared with male condom promotion only.

Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya.

OBJECTIVE: To measure the impact on sexually transmitted infection (STI) prevalence of a female condom introduction and risk-reduction program at Kenyan agricultural sites. DESIGN: We conducted a cluster-randomized trial to determine whether a replicable, community-level intervention would reduce STI prevalence. METHODS: Six matched pairs of tea, coffee and flower plantations were identified. The six intervention sites received an information/motivation program with free distribution of female and male condoms, and six control sites received only male condoms and related information. Participants were tested for cervical gonorrhea and chlamydia by ligase chain reaction on urine specimens, and vaginal trichomoniasis by culture, at baseline, 6 and 12 months. RESULTS: Participants at intervention (n = 969) and control sites (n = 960) were similar; baseline STI prevalence was 23.9%. Consistent male condom use was more than 20% at 12 months. Consistent female condom use was reported by 11 and 7% of intervention site women at 6 and 12 months. Unadjusted STI prevalence was 16.5 and 17.4% at 6 months, and 18.3 and 18.5% at 12 months, at the intervention and control sites, respectively. Logistic regression models confirmed the null effect of the female condom intervention. CONCLUSIONS: Female condom introduction did not enhance STI prevention at these sites. It is unclear which aspects of the intervention -- STI education, condom promotion, case management -- were associated with decreased STI prevalence from baseline to follow-up.