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At least 19 recordsLinked to original sources

Use of a vaginal sponge during aerobic exercises in patients with stress urinary incontinence.

A newly marketed vaginal sponge intended to support the urethra was tested during aerobic exercise in a group of 6 women suffering from stress urinary incontinence. The patients performed half an hour of aerobic exercises on 2 consecutive days, with and without the vaginal sponge. A pad was worn during exercise and weighed before and after. Without the vaginal sponge the patients had a mean loss of 7 g (range 2-18 g) during exercise. With the vaginal sponge in situ there was no leakage. The sponge can be recommended for use during sports in patients with mild to moderate incontinence.

Adult↗

[Benzalkonium chloride for vaginal contraception--the vaginal sponge].

From March 1986 to December 1987, a vaginal contraceptive, not yet commercially available in Germany, was studied in 56 women. The substance benzalconium chloride (BZC) was contained in vaginal sponges (n = 46), pessaries (n = 4) and cream (n = 6) at a dose rate of 1.18%. BZC is a surfactant of the ammonium series that ruptures the spermatozoal membrane. It is also a powerful bactericide and viricide. The advantages of the vaginal sponge (intercourse is safe immediately after insertion for the next 24 h and for multiple intercourses) made it pleasant for the women. The rate of transitory local side effects (16%) was acceptable. The vaginal contraception did not interfere with the sexual life. In 645 months of use 10 pregnancies occurred of which 9 happened with the sponge (PI 20.3). Its fixation before the cervix and the release of the spermicide is not reliable enough, so that we cannot recommend the sponge as a safe vaginal contraceptive.

Adult↗

Estrus synchronization in dairy goats: use of fluorogestone acetate vaginal sponges or norgestomet ear implants.

The ultimate aim of any estrus synchronization method is to allow artificial insemination at a predetermined time after the end of treatment. This requires a very tight synchronization of estrus which is not observed in goats after administration of the usual fluorogestone acetate (FGA)/prostaglandin (PG) F2 alpha/equine chorionic gonadotrophin (eCG) treatment. The possibility to improve the synchronization of estrus and luteinizing hormone (LH) peak with different progestagens (FGA versus norgestomet) and routes of administration (vaginal sponge versus subcutaneous ear implant) was evaluated in two experiments where goats received one of three progestagen treatments: (1) a vaginal sponge impregnated with 45 mg of FGA, (2) a half-implant of norgestomet, or (3) a whole implant containing 3 mg of norgestomet. The progestagens were left in place for 11 days and intramuscular injections of 400 or 500 IU of eCG (according to milk yield) and 50 micrograms of an analogue of PGF2 alpha (cloprostenol) were given 48 h prior to progestagen removal. In Experiment 1, 117 cycling goats were checked for the time of onset of estrus, preovulatory LH peak and ovulation rate following estrus synchronization treatment. Goats treated with half-implants came into estrus earlier than those receiving vaginal sponges (27.8 +/- 5.0 h vs. 33.0 +/- 6.6 h, respectively; P < 0.05). No effect of progestagen priming was observed on the variability of the onset of estrus. However, the interval between the time of onset of estrus and LH peak was more variable (P < 0.05) in goats treated with half-implants. In Experiment 2, 170 non-cycling goats were monitored for the time of onset of estrus, percentage of females ovulating, fertility and prolificacy after estrus induction treatment and artificial insemination with frozen-thawed semen performed 24 h after the onset of estrus. No effect of progestagen treatment was observed either on the time or the variability of onset of estrus. The percentage of goats ovulating and overall fertility rate were higher (P < 0.05) in goats receiving vaginal sponges (98.2% and 75.0%, respectively) than those treated with half-implants (81.8% and 45.5%, respectively). However, no significant difference was observed, for the same parameters, in animals receiving implants (86.3% and 58.8%, respectively). In conclusion, estrus synchronization with a norgestomet implant or half-implant did not reduce the variability in the onset of estrus and LH peak. The fertility tended to be lower in goats treated with a whole implant and was significantly decreased in goats which received a half-implant.

Animals↗

Polyurethane contraceptive vaginal sponge: product modifications resulting from user experience.

A preliminary study of a new contraceptive vaginal sponge containing the spermicide nonoxynol -9 (N-9), was undertaken to assess acceptability of the method among a group of sexually active volunteers in Mexico City. Numerous modifications of the product and its packaging resulted from user experience and feedback to the physicians and bioengineers conducting the study. Although determining efficacy of the sponge was not an objective, it quickly became clear that spermicide is a crucial component of the intravaginal sponge contraceptive system; a high incidence of pregnancies led us to increase the spermicide level from 10% to 20%, then to the current 30% of dry sponge weight, or about 1.0 gram per sponge. (It should be noted that the high pregnancy rates were consistent with our experience using other vaginal contraceptive methods in the same clinic population). This initial evaluation of the contraceptive sponge has resulted in significant modification which should increase its acceptability to a small but important group of contracepting women. The sponge is currently being evaluated by the International Fertility Research Program (IFRP) in multicentered comparative clinical trials to determine use-effectiveness and acceptability in various cultures.

Clinical Trials as Topic↗

Metronidazole-containing vaginal sponges for the treatment of bacterial vaginosis.

Currently, there is no FDA approved treatment for bacterial vaginosis (BV), although various oral dosages of metronidazole are used to treat this condition. A vaginal therapeutic sponge (VLI Corporation) that releases metronidazole over a 24 h use period has been developed for the treatment of BV. Each sponge contains 250 mg of metronidazole. The safety and effectiveness of using one or three metronidazole-containing vaginal sponges for the treatment of BV was evaluated in 40 patients. Use of a single sponge resulted in a cure rate of 38.9%. With three sponges the cure rate was 94.4%. Cure was defined as the absence of signs and symptoms (vaginal discharge, elevated pH, KOH prep odor, and 'clue' cells) at the one and four week follow-up visits. The sexual partners of most women were also treated with metronidazole (2 g po in one dose). None of the women were discontinued from treatment because of any adverse effects. Side-effects were minimal and required no treatment. The cure rate with the three vaginal sponge dosage appears to be similar to that associated with oral dosages of metronidazole.

Administration, Intravaginal↗

Seasonal and individual effects on ovarian and endocrine responses of mares to a synchronization treatment with progestagen-impregnated vaginal sponges.

The 8 saddle-type mares were treated with progestagen-impregnated vaginal sponges for 8 days and prostaglandin on the day of sponge removal. The treatment was given at random days of the cycle in April, May, July and September. Sponge insertion induced a sharp decrease in LH levels; at sponge removal, there was an immediate increase in LH and a large FSH rebound. Ovulation was synchronized 11 +/- 2 . 8 days (s.d.) after the end of treatment. In April the interval from sponge removal to ovulation was longer (14 days compared with 10 . 1, 10 . 7 and 10 . 2 days), the basal and peak LH levels lower, and follicular growth more delayed than in the 3 other months. In July, there was a prolonged oestrogen preovulatory rise and reduced FSH levels. Numerous individual differences were shown, but none was significantly linked to the interval from sponge removal to ovulation. Within the 3 months when response was unaffected by season, the interval from end of treatment to ovulation was correlated with progesterone (r = 0 . 45 and r = 0 . 50) and FSH (r = -0 . 48 and r = -0 . 49) levels at Days 5 . 6 and 7 . 8 after sponge insertion. This means that in treated mares that have an active corpus luteum at the end of treatment there will be low FSH levels at this time and ovulation will be late. A good prediction of the ovulation time after such a synchronization treatment must therefore take into account season, animal and time of treatment in the oestrous cycle.

Animals↗

Effect of Merocel vaginal sponge on growth of Staphylococcus aureus and production of toxic shock syndrome-associated toxins.

BACKGROUND: Staphylococcus aureus toxic shock syndrome toxin-1 and enterotoxin B are the major causes of toxic shock syndrome. These toxins are produced in sufficient concentrations to produce illness in the presence of certain tampons. This necessitates evaluating tampons, as well as wound dressings for their effects on S. aureus growth and toxin production. STUDY DESIGN: In this study, the Merocel vaginal sponge was evaluated both in vitro and in vivo in a rabbit model for effect on S. aureus. The Merocel sponge was tested in Erlenmeyer shake flasks containing growth media and in dialysis tubing immersed in agar growth media for both effect on S. aureus plate counts compared to media alone and effect on production of toxic shock syndrome toxins. The in vivo test included placement of Merocel sponges subcutaneously along the flanks of rabbits with subsequent inoculation with toxic shock syndrome bacteria and evaluation for development of illness and death. RESULTS: In the two standard in vitro tests, the shake flask and tampon sac, the Merocel sponge inhibited both growth of toxic shock syndrome S. aureus and production of toxic shock syndrome toxin-1 and enterotoxin B. The Merocel sponge also prevented development of toxic shock syndrome in a rabbit model. CONCLUSIONS: The data suggest the Merocel sponge may reduce the risk of development of toxic shock syndrome in association with its use. These studies may serve as models for evaluation of other products that are intended to be used on mucosal and skin surfaces, for their effect on toxic shock syndrome toxins.

Animals↗

Spermicidal and antiviral properties of cholic acid: contraceptive efficacy of a new vaginal sponge (Protectaid) containing sodium cholate.

Cholic acid (sodium cholate) exhibits a strong spermicidal and antiviral [anti-human immunodeficiency virus (HIV)-1] activity. The same effects are observed for F-5 Gel, the active mixture of a new contraceptive sponge (Protectaid), which contains sodium cholate in association with low concentrations (0.5%) of nonoxynol-9 and benzalkonium chloride. Both cholic acid and the F-5 Gel exert a dose-dependent, in-vitro inhibitory effect (i) on the activity of HIV-1 associated reverse transcriptase in an acellular system and (ii) on the potential of HIV-1 efficiently to infect human lymphocytes. During 12 months use, the contraceptive efficacy of the 'Protectaid' sponge was 100% in 20 young women who had chosen this method for reasons of both contraception and anti-sexually transmitted disease. No side-effects were recorded throughout this period. Cervical cultures at 6-month intervals showed the presence of Mycoplasma hominis and Candida albicans in one or two cases. The combined spermicidal and anti-HIV properties of cholic acid reported in this paper and used in the 'Protectaid' sponge offer a new and modern protective method of contraception.

Adult↗

Recurrent bacterial vaginosis: association with vaginal sponge use.

A hypothesis-generation study was conducted to examine risk factors for bacterial vaginosis recurrences among women participating in a randomized controlled trial of male sexual partner treatment. Of the 140 women enrolled in the trial, 72 had a normal vaginal gram-stained slide at the first follow-up visit and were included in this analysis. Nineteen of the 72 (26.2%) women developed a bacterial vaginosis recurrence documented by a vaginal gram-stained slide during the 6-week follow-up period. Of the 19 women, 4 of 6 sponge users (66%) developed a bacterial vaginosis recurrence (RR 2.93, 95% CI: 1.43-6.02). Logistic regression analysis supported the association between sponge use and bacterial vaginosis recurrences (adjusted RR 2.71, 95% CI: 1.06-6.99) but revealed that an apparent protective effect of diaphragm use was due to the confounding effect of sexual partner treatment. Our hypothesis is that bacterial vaginosis recurrences may be due to factors other than sexual transmission, such as sponge use. Further studies are needed to examine risk factors for bacterial vaginosis recurrences. In the interim, physicians might suggest another form of contraception to their sponge-using patient with frequent bacterial vaginosis infections.

Adolescent↗

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↗