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PubMed1992

Assessment of a new modified soft jelly capsule containing nonoxynol as spermicide contraceptive.

The mean rupture time, after its vaginal insertion, of a new modified soft jelly capsule containing nonoxynol-9 (DF-486) was investigated in 40 women. The subjects were randomly allocated to 8 study groups. The capsules remained in the vagina from 2-13 minutes. Vaginal infection, vaginal dryness, and multiparity, were recorded. Capsule rupture was not observed at minute 2; 20% of capsules that remained in the vagina 3 minutes suffered rupture, as did 80% of capsules that remained 4, 5 and 7 minutes, and 100% of those remaining 9 minutes or more. The mean rupture time of the studied capsules was 8.2 minutes with 95% confidence limits of 6.2 and 8.8 minutes. At minutes 2-7, vaginal infection, dryness and tone diminution probably accounted for lack of rupture; after minute 7, these factors did not influence capsule rupture.

Administration, Intravaginal↗
PubMed1990

Dilatation of the cervix with dinoprostone ('Prepidil gel') prior to insertion of an intrauterine device: report of two cases.

Routine insertion of an intrauterine device (IUD) is usually a simple procedure in parous and nulliparous subjects. There is normally very little cervical resistance, depending on the type of IUD used. We describe two cases in which cervical dilatation to allow passage of an IUD was facilitated by the intracervical insertion of 0.5 mg of PGE2 gel. The use of PGE2 gel in subjects where there appears to be marked cervical resistance at the level of the internal os probably allows safer introduction of the IUD using less force than after using analgesia to the cervix alone or a paracervical block. It is also faster and more convenient than using osmotic dilators. We recommend the use of 0.5 to 0.25 mg of PGE2 gel inserted into the cervix about half an hour to two hours prior to attempting insertion of the intrauterine device in women in whom there appears to be an abnormally high resistance at the level of the internal cervical os. The method appears to be simple and physiologically acceptable.

Administration, Intravaginal↗
PubMed1992

Clinical evaluation of quinacrine pellets for chemical female sterilization.

Under the auspices of the Coordinating Board of Indonesian Fertility Research (BKS PENFIN), a clinical trial was undertaken to examine the safety and effectiveness of the quinacrine pellet method for nonsurgical female sterilization. One hundred women were selected to receive 3 monthly insertions of 250 mg of quinacrine and were followed up at 1, 3, 6 and 12 months after the third insertion. Socioeconomic data and complaints and menstrual patterns at each insertion and every follow-up visit were recorded, as were all failures. The life-table failure rate was determined to be 3.1. The continuation rate in this study was 96% at 1 year. Just over one-fifth of the women had amenorrhea by the third insertion, but most returned to normal by 1 year, and it appears that this amenorrhea was transient in nature. The method proved to be safe and effective, suggesting that larger clinical trials are in order.

Administration, Intravaginal↗
PubMed1986

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↗
PubMed1992

Effects of protracted administration of estriol on the lower genito urinary tract in postmenopausal women.

We investigated 80 postmenopausal women, 48 of whom (60%) agreed to undergo long-term treatment with estriol suppositories. All had symptoms of vaginal atrophy and urinary incontinence. Endometrial samples were taken after 8-10 years of therapy. Estriol had induced slight proliferative changes in the endometrium in 7 of 48 patients studied by endometrial sampling. 75% of the women reported significant subjective improvement of stress incontinence. Estriol supplementation did not produce any significant change in urethral pressure, functional length, or cystometric parameters. However, a significant increase in pressure transmission ratio to the proximal urethra was noted after vaginal medication with estriol. Replacement therapy in post-menopausal women must take into account the patients perception of risks and benefits. The risk of estriol treatment is insignificant.

Administration, Intravaginal↗
PubMed1990

Induction of labour postdates in primiparae using vaginal prostaglandin tablets.

The management of pregnancy after 40 completed weeks remains controversial because induction of labour has been, in the past, associated with an increase in the incidence of caesarean section. This study examined the use of vaginal prostaglandin tablets for the induction of labour in selected primiparae after forty one weeks of pregnancy. The outcome of prostaglandin induction in 118 consecutive patients was compared with the outcome in 90 consecutive patients who went into labour spontaneously at the same gestation before induction could be undertaken. The active management of labour was applied in both groups and, therefore, the management of labour was strictly standardised. There was no difference between the two groups in the mode of delivery. Nor was prostaglandin induction associated with an increased incidence of prolonged labour. In selected primiparae, the cautious use of vaginal prostaglandin tablets can induce labour successfully postdates without increasing the complications of labour. A larger study is required to examine the effects of the induction of labour at this gestation on the fetal outcome.

Administration, Intravaginal↗
PubMed2005

[Vesicovaginal fistulas].

Vesicovaginal fistulas are often the result of obstetric trauma in third world countries or gynaecologic surgery in developed countries. The incidence of obstetric trauma is approximately 3-4/1000 births in West Africa. The incidence of fistulas as a result of surgery has remained relatively unchanged for years; 75% occur during gynaecologic procedures. The main clinical symptom of a vesicovaginal fistula is urine loss. Different surgical techniques with similar repair results are available: transvaginal approach, transvesical approach and transperitoneal approach. Irrespective of the approach used, requirements for successful repair include adequate surgical exposure, wide mobilization of the bladder and vagina, excision of the fistula tract, tension-free closure of the bladder and vagina, and placement of an interposition flap, i.e. Martius flap, omentum, peritoneum, when indicated. Using these surgical techniques, around 85% of women can be cured from their vesicovaginal fistula with a single operation.

Administration, Intravaginal↗
PubMed2001

A systematic review of estrogens for recurrent urinary tract infections: third report of the hormones and urogenital therapy (HUT) committee.

Our objective was to apply a meta-analysis to the available data to evaluate the effect of estrogen supplementation in the prevention of recurrent urinary tract infections in postmenopausal women. The literature review incorporated articles based on a search of Excerpta Medica, Medline, Science Citation Index and a manual search of commonly read journals in the fields of urology, gynecology, gerontology and primary healthcare, from January 1969 to December 1998. The search was not limited to English-language publications. Inclusion criteria were peer-reviewed articles containing original data with a primary outcome of symptomatic urinary tract infections and an estrogen-treated group. Articles were categorized into randomized controlled trials, case-control studies and self-controlled series. Of the articles reviewed, five were randomized controlled trials, two were case-control studies and three were self-control series. Meta-analysis of data from 334 subjects revealed a significant benefit from estrogen over placebo (odds ratio = 2.51, 95% confidence interval = 1.48 4.25). The most convincing results were obtained using the vaginal route of administration. A variety of different estrogen preparations have been employed in the few published reports, making comparison of the data difficult. However, vaginal administration seems to be effective in the prevention of recurrent urinary tract infections in postmenopausal women.

Administration, Intravaginal↗
PubMed2002

Topical antiseptics as an alternative in the treatment of acute vulvovaginal candidosis.

The aim of this prospective, multicenter, randomized, case-control study was to investigate the efficacy of a nonspecific mucosal antiseptic (octenidine dihydrochloride, phenoxyethanol) with proven antifungal effects, in patients with acute symptomatic vaginal candidosis, in comparison with a specific topical antifungal agent (clotrimazole), particularly in respect to non-Candida albicans yeasts. A total of 491 patients from 29 gynecological practices, who had new clinical vaginal mycosis, not treated with antifungal agents in the last 12 months, were included in the study. The diagnosis in each case was confirmed by microscopy or positive culture. The majority of the vaginal mycoses were infections with C. albicans (72%). In 28% of patients a non- Candida species (mainly C. glabrata) contributed to the infection. Except for vaginal discharge, the success of treatment was between 71% and 91% for both clinical and subjective parameters. The control preparation was significantly better than the treatment in the test group. Mycological cure rate on the basis of cultures was 78% in the test group and 87% in the control group. These results were also significantly different. The relatively high proportion of C. glabrata isolates in this study tended to be more successfully treated by the antiseptic (to 72%) than by the administration of clotrimazole (59%). Even though therapeutic success with clotrimazole was overall significantly better than with the test preparation, the success of treatment with the antiseptic used was within the range between 70% and 90% described for topical antifungal agents. Both the good efficacy of the topical antiseptic and the increased prevalence of non-Candida albicans species causing vaginal infections mean that the use of an antiseptic may be considered a suitable alternative therapeutic concept to an appropriate topical antifungal agent in the treatment of acute vaginal candidosis.

Acute Disease↗
PubMed2005

Effect of vaginal metronidazole + miconazole treatment during pregnancy for gestational age and birth weight in a population-based study.

The objective of the study was to check the effect of the combination of metronidazole and miconazole (M+M) for the prevention of sexually transmitted infections/disorders related preterm delivery/birth. Antiprotozoal vaginal metronidazole was not able to prevent preterm birth, while the antifungal topical miconazole use showed some reduction in preterm birth in our previous studies. The population-based large control (without any defects) data set of the Hungarian Case-Control Surveillance System of Congenital Abnormalities was used for the evaluation of the combination of M+M for birth outcomes. Of 38,151 controls, 846 (2.2%) had treatment with vaginal tablet of M+M for vaginal infections. The prevalence of preterm birth was 9.5% after this treatment compared with the 9.2% of preterm birth in the untreated group. Thus the combination of M+M was not able to reduce the preterm birth associated with vulvovaginal infections/disorders.

Administration, Intravaginal↗
PubMed2005

Comparison of isosorbide mononitrate (Mono Mack) and misoprostol (Cytotec) for cervical ripening in the first trimester missed abortion.

OBJECTIVE: The objective of this study was to compare NO-donor isosorbide mononitrate to misoprostol, both applied as vaginal tablets for cervical ripening prior to first trimester curettage in patients with missed abortion. MATERIALS AND METHODS: Thirty women with missed abortion were assigned after a random list to be treated either with 200 microg gemeprost (Cytotec, Pfizer, Germany) or with 40 mg isosorbide mononitrate for cervical priming at least 3 h before curettage. Vaginal bleeding or the intracervical presence of products of conception was documented. The largest number of Hegar's dilator, which could be introduced without difficulty and the largest number of Hegar's dilator at which cervical dilation was performed and the ease of mechanical dilation was assessed. RESULTS: There were no significant differences in cervical ripeness before procedure nor in ease of dilation. In the misoprostol group, the cervical canal was more dilated before any procedure (median of Hegar's dilator 6 vs. 5) and after dilation (median of Hegar's dilator 11 vs. 10), although this difference was not significant. Vaginal bleeding occurred in two patients in each group. Products of conception were only found in the cervix of one patient of the misoprostol group. SYNOPSIS: Vaginal application of isosorbidemononitrate in cervical priming prior to curettage abortion is as effective as vaginal application of misoprostol.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Randomized controlled trial of vaginal misoprostol versus vaginal misoprostol and isosorbide dinitrate for termination of pregnancy at 13-29 weeks.

When compared to the use of 12 hourly 200 microg vaginal misoprostol on its own, the addition of a single dose of 5 mg did not significantly increase the abortion or delivery rate in pregnancy termination at 13-29 weeks gestation. All patients were given intravenous syntocinon at 30 mU/min from the first dose of misoprostol onwards.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

A comparison of induction with vaginal prostaglandin E2 versus spontaneous of labor in grand multiparous women.

OBJECTIVE: To compare the outcome of labor in grand multiparous women (para 6 or more) who had induction of labor with vaginal prostaglandin E2 with grand multiparous women in spontaneous labor. METHODS: A retrospective case-control study was performed, 202 grand multiparous women were induced labor with vaginal prostaglandin E2 and compared with outcomes with grand multiparous women who entered in spontaneous labor and delivered during the same study period and served as control group. RESULTS: There were no statistically significant differences in the duration of labor, fetal birth weight, use of oxytocin augmentation, and Apgar scores in the two groups. Fourteen women (6.9%) in the induction group delivered by cesarean section compared to six woman (3.0%) in the control group. This was a statistically significant difference (P = 0.01). In the induction group, the mean duration of the hospital stay was longer (P = 0.003) and there was one neonatal fetal death and one uterus rupture. CONCLUSION: Induction of labor with vaginal prostaglandin E2 in grand multiparous women is still relatively safe.

Administration, Intravaginal↗
PubMed2005

Comparative efficacy of two regimens in syndromic management of lower genital infections.

AIM: The aim of this study was to compare the efficacy and safety of two combination regimens in the syndromic management of lower genital infection. Seventy-two non-pregnant women presenting with symptoms of lower genital infection diagnosed as vaginitis on clinical examination and lacking obvious upper genital infection were enrolled to one of the two treatment regimens as a syndromic treatment. No investigations were performed to cut the cost and to avoid the loss of patients on follow-up. Thirty-seven women (group I) were prescribed a course of clotrimazole (Imidil, Lyka) 100 mg vaginal pessaries for 6 days. Along with their partners they were prescribed 2 gm secnidazole (Secnil forte) and 150 mg fluconazole (Syscan) as a single therapy. Thirty-five women (group II) were prescribed vaginal clotrimazole as mentioned above. A combination kit containing 150 mg fluconazole, 2 gm secnidazole and 1 gm azithromycin (FAS-3 kit, Lyka) was also prescribed to both partners with the advice to take azithromycin on empty stomach, and the other three tablets after food. RESULTS: All women in both groups were seen after 1 week for relief of symptoms and after 1 month for any recurrence. Mean parity was 2.7 and 3.0, respectively. The total symptomatic relief was observed in 67.6 and 94.3% cases, partial relief in 27 and 5.7% cases and no relief was observed in 5.4% and nil cases, respectively, in the two groups. Recurrence was seen in two and nil cases, respectively, in the two groups. Most women tolerated both the treatments well with no major side effect in any case. Treatment cost was higher in group II (Rupees 120) than in group I (Rupees 65). CONCLUSIONS: Both combination kits with local clotrimazole were reasonably effective and safe in the syndromic approach for lower genital infections. The combination kit with azithromycin, secnidazole and fluconazole was more effective with better symptomatic relief and less recurrence rate and may be routinely recommended in all cases of lower genital infection as a cost effective, safe and effective strategy.

Administration, Intravaginal↗
PubMed2006

Recombinant human lactoferrin has a potential to suppresses uterine cervical ripening in preterm delivery in animal model.

OBJECTIVE: To investigate the effect of recombinant human lactoferrin (rhLF) on cervical ripening using a rabbit model in which preterm labor was induced by bacterial endotoxin lipopolysaccharide (LPS). STUDY DESIGN: Timed pregnant rabbits (New Zealand White, 3-4 kg, day 14) were randomly assigned to the following treatment groups: Group A, LPS + rhLF (n = 4); Group B, LPS (n = 4); and Group C, control (n = 4). Recombinant human lactoferrin (10 microg) was administrated to pregnant rabbits in Group A and not in Group B. Lipopolysaccharide (100 microg) was given to the rabbits in both groups for 3 days (days14-16). Drugs were administered as a vaginal suppository. On day 18, the rabbits were anesthetized with intramuscular ketamine hydrochloride (20 mg/kg) and diazepam (4 mg/kg). Both cervices of the rabbit uterus, which is bicorpus-bicolli, were taken out. One cervix was placed in 10% formalin solution for a histological study with standard hematoxylin-eosin staining. The other was used for an extension test to assess the grade of ripening. Extension was measured after a 5-mm length of cervical tissue was loaded with 5.8 g. RESULTS: The histological study showed remarkably loose and edematous connective tissue in Group B cervices. Cervical tissues in Group A was not different from those in Group C. Extension lengths were 2.2 +/- 0.2 mm in Group A, 7.0 +/- 2.7 mm in Group B, and 1.7 +/- 0.3 mm in Group C. CONCLUSION: These results suggest that rhLF inhibits cervical maturation induced by LPS in a rabbit model and may have a potential to prevent preterm delivery caused by cervical infection and ripening.

Administration, Intravaginal↗