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PubMed1985

Worldwide method effectiveness of the Today vaginal contraceptive sponge.

The Today vaginal contraceptive sponge is made of polyurethane and contains 1 gram of the spermicide nonoxynol-9. Following preclinical and phase I and II clinical trials, extensive worldwide phase III trials were conducted. These multiclinic trials were conducted according to a common protocol with regularly scheduled follow-up visits and examinations. The cumulative first year method effectiveness rate (life table) was 90 per 100 women. The second year rate was 97 per 100 women. No statistically significant difference was found in method failures between nulliparous and parous women. No serious complications occurred in over 1000 women-years of sponge use.

Adult↗
PubMed1987

Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial.

This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.

Adolescent↗
PubMed1984

The vaginal contraceptive sponge: a new non-prescription barrier contraceptive.

The Today vaginal contraceptive sponge is a non-prescription barrier contraceptive which, after rigorous testing, was recently approved by the Food and Drug Administration (FDA) and marketed nationally. It is a cup-shaped white polyurethane sponge six cm in diameter and 1.5 cm thick, with a removal loop. The hydrophilic sponge is impregnated with spermicide. The user-inserted sponge can remain in place for multiple coital acts during a 24-hour period, and must remain in place for six hours after the last ejaculation for a maximum of 30 hours. It acts by spermicidal action, absorption of sperm and as a mechanical barrier. Effectiveness is comparable to other vaginal contraceptives: 84 percent use and 89-91 percent theoretical use effectiveness. The FDA determined that the sponge does not pose a greater risk of toxic shock syndrome (TSS) than tampon use. Concerns regarding carcinogens were refuted. Spermicide teratogenicity, while under continued study, has not been supported. Advantages include spontaneity, convenience and comfort. Disadvantages include removal and retention problems. Providers teaching women proper placement and removal of the sponge is encouraged. It is a viable barrier-method alternative.

Clinical Trials as Topic↗
PubMed1985

Collagen sponge as vaginal contraceptive barrier: critical summary of seven years of research.

Extensive testing of collagen sponge as a vaginal contraceptive (mechanical and chemical) showed that the original expectations regarding the safety, convenience, and efficacy were not met. The collagen sponge was tested both as a cylinder and as a diaphragm and used as such or impregnated with spermicidal detergent or with zinc salt. The collagen sponge must be larger than 6 cm in diameter in order to serve as a mechanical barrier that will not be dislodged during physical activity. This creates problems with the ease of insertion and with the partners' awareness of the barrier. When the collagen sponge containing ejaculate is left in the vagina greater than 48 hours, it develops an offensive odor. The original acidity of the collagen sponge (pH 3.5, 0.1 mol/L) is soon neutralized by the large volume of alkaline vaginal secretions. In vitro studies showed that up to 10 mg of nonoxynol 9 per milliliter of growth medium did not inhibit the growth of Staphylococcus aureus. These effects, as well as the large surface area of the resilient sponge, present a potential risk for growing staphylococci within the collagen sponge. The capacity of the collagen sponge to absorb a large volume of cervical and vaginal fluid produced two symptoms that were annoying to the volunteers: an awareness of either vaginal dryness during intercourse or, conversely, saturation of the sponge from the vagina. Postcoital studies showed viable spermatozoa in the cervical mucus in 25% of the tests with the nonmedicated cylindrical sponge but in only 6% of tests with the sponge containing nonoxynol 9. The results of clinical trials conducted at four centers support the view that collagen sponge as a vaginal contraceptive barrier method is inconvenient to both partners, not effective enough to compete with present methods of vaginal contraception, and possibly might be unsafe because of the capacity to grow bacteria. Despite the negative end result of this goal-oriented research, we believe that our studies have contributed to a better understanding of vaginal physiologic features, the safety and effectiveness of spermicidal detergents, and the mechanisms of vaginal malodor. Although the acceptability study showed some advantages of the collagen sponge over the rubber diaphragm, the overall acceptability of the collagen sponge diaphragm was no better than that of the rubber diaphragm. For all these reasons, including the possible risk of an increased incidence of toxic shock syndrome, we have discontinued further testing of either type of collagen sponge as a vaginal barrier method.

Collagen↗
PubMed1986

Toxic shock syndrome and the vaginal contraceptive sponge.

Thirteen confirmed cases of toxic shock syndrome temporally related to use of the vaginal contraceptive sponge have been reported. The observed risk of toxic shock syndrome in sponge users may be elevated above estimated background rates, but this risk remains very low. Traumatic manipulation of the sponge, use during menstruation or the puerperium, and prolonged retention of the sponge may additionally increase toxic shock syndrome risk. As with all contraceptives, risks must be balanced against benefits.

Adolescent↗
PubMed1984

Intravaginal controlled administration of flurogestone acetate II: Development of an in vitro system for studying the intravaginal release and permeation of flurogestone acetate.

A relatively simple and easily constructed in vitro system was developed for studying the mechanism of release and intravaginal absorption of flurogestone acetate from vaginal sponges. The stability-indicating high-performance liquid chromatographic method developed earlier was used to provide a rapid, reproducible, and sensitive assay. The in vitro intravaginal release/permeation system developed was capable of determining the rate of flurogestone acetate release from vaginal sponges and, simultaneously, the rate of absorption through the vaginal wall. The design, calibration, and applicability of the system, and the release and absorption profiles of the drug from vaginal sponges in this system are discussed.

Absorption↗
PubMed1986

Effect of vaginal contraceptive sponges on growth of toxic shock syndrome-associated Staphylococcus aureus in vitro.

Toxic Shock Syndrome (TSS) is associated with certain toxin-producing strains of Staphylococcus aureus (TSS-S aureus), and with the use of some vaginal devices such as tampons or contraceptive diaphragms. The present study was designed to examine the effect of Nonoxynol-9 (N-9), and of a newly-approved vaginal contraceptive sponge (VCS) containing N-9 on the growth of TSS-S aureus in vitro. Flasks containing culture media inoculated with TSS-S aureus were incubated at 37 degrees C for 30 hours, in the presence or absence of either a VCS, or N-9 alone. At 0.5, 1, 2, 6, and 12 hours, there was suppression of TSS-S aureus colony counts in media containing VCS, compared to control. Colony counts from media containing N-9 demonstrated suppression at 0.5, 1, 2, and 6 hours. After incubation as long as 30 hours, colony counts from VCS-containing media approached, but did not exceed, counts from control media. From these data, it is concluded that this VCS containing N-9 does not enhance the growth of TSS-S aureus in vitro. Instead, an inhibition of bacterial growth for at least 12 hours is observed in media containing VCS, consistent with a bacteriostatic effect. If such an effect is also present in vivo, it would suggest that this type of VCS is unlikely to increase the risk of TSS.

Contraceptive Agents↗
PubMed1989

A study of the vaginal contraceptive sponge used with and without the fertility awareness method.

The actual effectiveness rates of natural and barrier methods of family planning are lower than the theoretical ones. If couples accurately defined the limits of the fertile phase and used barriers at that time, then actual effectiveness might increase. A randomized, controlled clinical trial was initiated to determine the effectiveness of the contraceptive sponge used only during the fertile time and to compare this with sponge use at every intercourse. Recruitment problems and discontinuation forced the early termination of this study, but qualitative information about compliance and acceptability was collected. Common sponge problems were reported as were misuses of the sponge, but problems and misuse were not related. Determination of the fertile phase was reportedly easy, but complaints of and discontinuation for inconvenience occurred. For unplanned pregnancies, contraceptive behaviors around the time of conception are presented.

Adolescent↗
PubMed1987

Superovulation and recovery of zygotes from Nubian and Alpine dairy goats.

Thirty-five purebred dairy goats (18 Alpines and 17 Nubians) were subjected to a superovulating hormone program consisting of an 11-d 6alpha-methyl-17alpha-acetoxy-progesterone; (MAP; 60 mg) intravaginal sponge treatment; 125 ug i.m. injections of the prostaglandin F(2alpha) analogue cloprostenol on d 1 and 9 of vaginal sponge treatment; and a 3-d, twice-a-day injection of 2.5 mg of pituitary follicle stimulating hormone (FSH-P) i.m. starting at day 9. Vaginal sponges were pulled the morning of day 11 at the time of the fifth FSH-P injection. Of 40 initiated superovulatory cycles, 33 does (10 Alpines and 23 Nubians) responded with an average of 17.7 (range 1 to 29) ovulations. There was no significant difference between the breeds with respect to corpora lutea (CLs) plus follicles ovarian response. A significantly greater (P< 0.05) number of Nubian does were in estrus and mated by 36 h after MAP sponge removal. All does that responded to treatment had done so within 72 h of sponge removal. Of the seven (17.5%) does that showed no estrous response to hormone treatment, six were Alpines (P < 0.01). Six goats (two Alpines and four Nubians) were subjected to a second hormone treatment cycle after a 45-d rest. Five of six does responded to a second hormone treatment cycle with four of five responding with a lower total ovarian response. The interval from sponge removal to mating did not affect the stage or quality of eggs harvested. Rather, the interval from mating to surgical flushing determined the stage of egg development. All animals examined from 24 to 32 h after initial mating had not ovulated. By 50 h, 20 of 22 does had ovulated. A total of 242 ovulated eggs (63%) was harvested, of which 199 (82%) were fertilized. Day 7 flushings yielded 36 eggs (67%), of which 28 (78%) were fertilized. This rate of superovulation, fertilization, and embryo recovery lends credibility to this technique in its ultimate objective of rapidly increasing the number of offspring from superior animals.

Journal Article↗
PubMed2002

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.

Contraceptive Devices, Female↗