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PubMedDate not supplied

Nonoxynol-9 vaginal pessary: a preliminary Indian experience.

BACKGROUND: Barrier methods of contraception do not have systemic effects and allow the user complete control over their use. For women, the ease of use of a contraceptive is often more important than its efficacy. Hence, barrier methods could be offered as a useful alternative method of contraception. Nonoxynol-9 (a spermicide) is a locally acting, non-hormonal method free from systemic side-efforts. It is a woman-controlled, reversible method which is to be used before intercourse. There are little data available on its efficacy, side-effects and acceptability among Indian women. METHODS: The vaginal pessary nonoxynol-9 was offered as a contraceptive option to 3200 women attending the Family Planning clinics at 31 Human Reproduction Research Centres (HRRCs) of the Indian Council of Medical Research. The other contraceptives offered included an intrauterine device, oral pills, condoms, Norplant, tubal sterilization and vasectomy using the cafeteria approach. Those who accepted nonoxynol-9 were followed up to assess the rates of continuation, failure and side-effects. RESULTS: The nonoxynol-9 pessary was accepted by 541 women who were followed up for 3470 woman-months of use. The reasons given for acceptance were that it was user-controlled and/or they did not wish to use other methods because of the side-effects or contraindications of these methods. The overall continuation rates were 41.2% and 33% at 9 and 12 months of use, respectively. Most women (31.3%) discontinued its use due to personal reasons such as husband dissatisfaction, desire for further pregnancy, irregular use of pessary and difficulty in insertion. Twenty-nine women became pregnant during the study period (15 due to method failure and 14 due to user failure) giving a use-effectiveness of 8.8% at 12 months. The method failure rate was 4.3% at 12 months of use. The failure rates were lower compared with the reported failure rates of barrier contraceptives (1%-30% at 1 year of use) and the side-effects were minimal. CONCLUSION: Nonoxynol-9 had low acceptability (16.9%) and overall continuation rates--41.2% and 33% at 9 and 12 months of use. It could be offered to women looking for a short term, user-controlled contraceptive.

Adolescent↗

PubMed1983

Urodynamic effects of a vaginal pessary in women with stress urinary incontinence.

The manner in which a vaginal pessary restores urinary continence is poorly understood. This report provides an explanation. Following placement of the vaginal pessary, detailed urodynamic studies in a group of 12 women with stress urinary incontinence demonstrated consistent and significant (p less than 0.005) increase in urethral functional length and urethral closure pressure under varying stressful conditions, when compared with prepessary studies. Postpessary stress testing also became normal (p less than 0.005). Prepessary and postpessary simultaneous voiding urethrocystometry and instrumented uroflowmetry demonstrated absence of obstruction to free flow of urine. Clinically, 10 of 12 patients became continent. Characteristic postpessary urodynamic alterations and Q-tip test changes provided an objective explanation that the vaginal pessary restored continence by stabilizing the urethra and urethrovesical junction to allow proper pressure transmission and by actively increasing urethral resistance to escape of urine under resting and stressful conditions.

Female↗

PubMed1984

The effect of vaginal prostaglandin E2 pessaries on induction of labor.

In a prospective randomized study, patients with a valid obstetric indication for induction of labor received either 3 mg prostaglandin E2 vaginal pessaries immediately prior to oxytocin (prostaglandin group, n = 99), or oxytocin alone (oxytocin group, n = 103). At the conclusion of the second day of induction, a significant reduction was noted in the incidence of failed induction in the prostaglandin group (4%) as compared to the oxytocin group (13%) (p less than 0.05). Twenty percent of patients in the prostaglandin group experienced successful induction with prostaglandin pessaries only. When oxytocin was required in the prostaglandin group, the maximal concentration of oxytocin infused and the duration at this concentration were significantly less than in the oxytocin group. No perinatal complications were attributed to the use of prostaglandin. Three minor maternal complications that were attributed to vaginal prostaglandin E2 did not require treatment. Our conclusion is that patients who require an induction of labor, when artificial rupture of the membranes is not feasible, benefit from the use of prostaglandin pessaries before the administration of oxytocin.

Cesarean Section↗

PubMed1999

Treatment of severe postpartum hemorrhage by rectally administered gemeprost pessaries.

OBJECTIVE: To assess the efficacy of rectally administered gemeprost pessaries in the treatment of severe postpartum hemorrhage. DESIGN: Retrospective analysis of a twelve month period in which all patients having postpartum hemorrhage treated with rectal gemeprost were analyzed. SETTING: Royal Darwin Hospital, Northern Territory, Australia. POPULATION: Fourteen women with established postpartum hemorrhage not responding to oxytocine and ergometrine regimens, or not responsive to oxytocine and having contraindications to ergometrine. MAIN OUTCOME MEASURES: Per vaginum bleeding with continued postpartum hemorrhage; adverse patient reactions to gemeprost; need for operative intervention. RESULTS: All patients who were treated with rectally administered gemeprost pessaries had cessation of bleeding per vaginum. There were no adverse side effects noted from the medication and no patient required surgical treatment. CONCLUSIONS: Rectally administered gemeprost administered pessaries appear to be safe and effective method of treating severe postpartum hemorrhage in those patients in whom the standard oxytocic regimens fail. This form of treatment may avoid the need for parenteral prostaglandins or surgical intervention.

Administration, Rectal↗

PubMed1990

A comparison of the efficacy of gemeprost vaginal pessaries and extra-amniotic prostaglandin E2 gel in the induction of middle trimester abortion.

In an open random allocation trial of 50 patients, 25 had abortion induced vaginally with gemeprost (16.16-dimethyl-trans-delta squared- prostaglandin E1 methyl ester; PGE) 1 mg pessaries inserted into the posterior fornix. The remainder received 7.5 mg PGE2 in a gel inserted into the extraamniotic space. Following the administration of 2 doses of PGE2 gel, abortion was achieved in 100% of the cases within 24 hours, whereas the group treated with a maximum of 3 gemeprost pessaries administered at 3-hour intervals only achieved abortion within 24 hours in 76% of the cases. 3 doses of gemeprost pessaries are the cost equivalent of 2 doses of PGE2 gel.

Abortion, Induced↗

PubMed2001

Spermicidal & contraceptive properties of Praneem polyherbal pessary.

BACKGROUND & OBJECTIVES: Though a number of barrier methods and potent spermicides are available, most of these have nonoxynol-9 (N-9) as the active ingredient which is observed to cause inflammation and genital ulceration on repeated use. The present study was undertaken to develop a safe spermicide with conjoint microbicidal properties. METHODS: A polyherbal pessary was formulated with purified ingredients from neem (Azadirachta indica) leaves, Sapindus mukerossi (pericarp of fruit) and Mentha citrata oil. Spermicidal action on human sperm was tested by Sander-Cramer slide test in vitro and by post coital tests in vivo. Contraceptive action was tested in rabbits. RESULTS: The combination of the three herbal ingredients resulted in the potentiation of the spermicidal action by 8-folds. The post coital tests confirmed the spermicidal properties of the Praneem polyherbal pessary (PPP) in women with high cervical mucous score around mid estrus. It also prevented in most women the migration of sperm into the cervical mucous. In 15 rabbits studied pregnancy was prevented by the intravaginal administration of PPP, whereas 13 of the 15 animals in the control group became pregnant. INTERPRETATION & CONCLUSION: The Praneem polyherbal pessary has potent spermicidal action on human sperm in vitro and in vivo. When applied in the vagina before mating, it prevented rabbits from becoming pregnant.

Female↗

PubMed2003

Trial of extra amniotic saline infusion with oxytocin versus prostaglandin E2 pessary for induction of labor.

OBJECTIVE: To determine the effectiveness and safety of cost-effective extra-amniotic saline infusion (EASI) and simultaneous intravenous oxytocin infusion versus prostaglandin E2 vaginal pessary (PGE2) for induction of labor. DESIGN: Prospective randomized comparative study. PLACE AND DURATION OF STUDY: Labor room at the Mother and Child Health Centre, PIMS, Islamabad from September 2000 to December 2001. SUBJECTS AND METHODS: Women with singleton alive pregnancies and Bishop score < or =6, requiring induction of labor at > or =37 weeks gestation were randomly assigned to induction either with PGE2 3 mg vaginal pessary in two doses 6 hourly or EASI for 12 hours with simultaneous intravenous oxytocin infusion. Artificial rupture of membranes was done 12 hours post-induction and oxytocin infusion started in PGE2. Main outcome measures were induction delivery interval and the mode of delivery. Secondary outcome measures were the change in modified Bishop score 6 hours postinduction and neonatal outcome in the two induction modes. RESULTS: After 4 exclusions, 100 women were recruited in each arm. Mean induction delivery interval was 11.1 and 14.3 hours (p=.00) in PGE2 and EASI respectively. The cesarean rate was 11% and 15% (p=0.4) in PGE2 and EASI respectively. Mean Bishop score at induction was 3.2 in PGE2 and 3.1 in EASI, while after 6 hours it was 4.8 and 6.8 (p=0.00) respectively. Mean APGAR scores at 1 and 10 minutes were identical that is 6.2 and 8.6 respectively. CONCLUSION: Both the modes of induction were equally safe and effective in terms of the mode of delivery and APGAR score. EASI, however, had more rapid cervical ripening and shorter induction delivery interval.

Adult↗

PubMed2007

Vesicovaginal fistula resulting from a well-cared-for pessary.

An 84-year-old vaginally grand multiparous woman presented with a vesicovaginal fistula (VVF) after appropriate use of a Gehrung pessary for the past 12 years for stage III pelvic organ prolapse. The patient reported strict adherence to removing her pessary nightly and replacing it in the morning for the last 12 years. One morning, she awoke and noted a sudden gush of urine through the vagina followed by continuous leakage. Given the complex nature of VVF repair with concurrent stage III pelvic organ prolapse, the patient was referred to urogynecologic care. A Latzko fistula repair and LeFort colpocleisis were performed without complication. The patient recovered well with complete resolution of her pelvic organ prolapse and VVF based on negative cystogram findings at 3 weeks postoperatively. At 12 weeks postoperatively the patient denied any urine leakage or pelvic organ prolapse.

Aged, 80 and over↗

PubMed1984

Preoperative dilatation of the first-trimester cervix: a comparison between Lamicel and 16,16-dimethyl-trans delta 2 prostaglandin E1 methyl ester pessaries.

Both Lamicel and 16,16-dimethyl-trans delta 2 prostaglandin (PG) E1 methyl ester pessaries have recently been shown to be effective for cervical dilatation prior to first-trimester abortion. In the study described, the force required to dilate the cervix prior to vaginal termination of pregnancy was measured in three groups of patients--a control group, a group which received Lamicel , and a group which received 16,16-dimethyl-trans delta 2 PGE1 methyl ester pessaries. The total force required to dilate the cervix to 10 mm was significantly reduced in the treated groups, but there was no significant difference between the two treatment regimens. The use of Lamicel is associated with fewer side effects.

16,16-Dimethylprostaglandin E2↗

PubMed1990

The efficacy of oral Mifepristone (RU 38,486) with a prostaglandin E1 analog vaginal pessary for the termination of early pregnancy: complications and patient acceptability.

Outpatient terminations were performed on 100 ultrasonographically confirmed pregnancies of less than or equal to 63 days with a single oral dose of RU 38,486 (600 mg) and a single vaginal pessary of 16,16-dimethyl-trans-delta 2-prostaglandin E1 (1 mg) 48 hours later. Abortion occurred in all patients; in 95 it was complete, in four it was incomplete, and one resulted in a missed abortion. In 88% the abortion occurred within 4 hours of prostaglandin treatment. A total of 25% of patients had nausea and 15% vomited after RU 38,486 treatment. After prostaglandin-treatment, 13% vomited, 10% had diarrhea, and 23% required administration of an opiate analgesic agent. No patient was transfused and there was no genital tract trauma; one case of suspected pelvic infection occurred. If the need for termination arose again, 88% would elect to use the method again, 9% would not. The combination of the antiprogestin RU 38,486 and a vaginal prostaglandin pessary appears to offer a safe, efficient, acceptable nonsurgical outpatient method of termination. Further studies on dosage and treatment protocols would be justified.

Abortifacient Agents↗

PubMed1992

A randomized trial of prostaglandin E2 in a controlled-release vaginal pessary for cervical ripening at term.

OBJECTIVE: The purpose of this study was to determine if prostaglandin E2 in a controlled-release vaginal pessary can produce cervical ripening at term. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled study conducted at a university center and involving 81 patients with 42 receiving active agent. Categoric data were analyzed by Pearson's chi 2 or logistic regression. Continuous variables were analyzed by analysis of variance and the F test. RESULTS: Prostaglandin E2 was significantly better than placebo at cervical ripening and at decreasing the time to rupture of membranes, the time to onset of labor, the need to give oxytocin, and the time to vaginal delivery. Multiparous women benefitted more than primiparous ones. The cesarean section rate decreased only for multiparous women. Uterine hyperstimulation occurred only with prostaglandin E2 and after the onset of labor. CONCLUSIONS: Prostaglandin E2, when administered in a controlled-release vaginal pessary, is affective in producing cervical ripening at term. This agent should be used on inpatients who are under continuous monitoring and it should be removed at the onset of labor.

Cervix Uteri↗

PubMed1983

Induction of labor with vaginal prostaglandin E2 pessaries.

Prostaglandin E2 vaginal pessaries (3 mg) were compared with conventional amniotomy and oxytocin infusion as a method of induction of labor in 160 patients in the study group compared with 160 in the control group. Each group consisted of 100 primigravidae and 60 multigravidae. When the features of labor, delivery and fetal status were analyzed for the study and the control groups, the patients who received PGE2 pessaries had a better outcome. The difference was more significant for those patients with a low Bishop score. Compared with controls, the PGE2-treated patients had fewer cesarean sections either for failed induction or fetal distress (P less than 0.01); the incidence of infants with low Apgar score was significantly less (P less than 0.05) and there were fewer postpartum haemorrhages (P less than 0.01).

Adolescent↗

PubMed1991

A comparison of single prostaglandin E2 vaginal tablet with prostaglandin E2 vaginal pessaries for induction of labor at term.

This study represents the first of its kind in Kuwait. Two preparations of prostaglandin E2 (PGE2) have been compared as agents for induction of labor. In a randomized controlled study of 200 women of low parity and unfavorable cervical induction features induction of labor by means of a single vaginal tablets of PGE2 was compared with locally prepared PGE2 vaginal pessaries. The gradual increase of uterine contractions and the establishment of labor in a similar way to that observed during spontaneous labor was more apparent after PGE2 tablets. Labor induction was successful in 80% of patients in PGE2 tablet group compared with 59% in PGE2 pessaries group. The incidence of cesarean section was equal in both groups (4%), but none was performed due to uterine hyperactivity. The data presented indicate that the PGE2 vaginal tablet is safe and effective in induction of labor in healthy women at term.

Administration, Intravaginal↗

PubMed1993

Prostaglandin E2 vaginal pessaries in the grandmultipara with an unripe cervix, a comparison of different parity groups.

OBJECTIVE: To determine the safety and efficiency of 3 mg prostaglandin E2 in pessary form as a method for induction of labor in grandmultiparous women. METHOD: Case notes were reviewed for 198 women at Jahra Hospital in Kuwait who underwent induction of labor between 37 and 43 weeks of gestation. All women had an unripe cervix. Fifty-nine women were nulliparous, 85 women were multiparous (parity 1-5) and 54 women were grandmultiparous (parity 6-12). Comparisons between groups were examined for statistical significance by: chi 2, ANOVA test, Kurskal-Wallis test and Spearman rank correlation test as appropriate. RESULT: Pregnant women in the grandmultiparous group needed fewer repeated doses (P < 0.001) and had a shorter mean induction delivery interval (P < 0.01) than women in the other two parity groups. There were no differences in the need for oxytocin augmentation or method of delivery between the three parity groups. CONCLUSION: Prostaglandin E2 vaginal pessaries proved to be a safe and effective method for induction of labor in grandmultiparous women.

Adult↗

PubMed1989

Comparative study of a two dose schedule of PGE2 3 mg pessary and 1700 micrograms film for induction of labour in nulliparae with poor cervical score.

Efficacy of a two dose schedule of 3 mg pessary or 1700 micrograms film of PGE2 for induction of labour was compared in nulliparae with poor cervical score. Patient characteristics in the two groups (43 in 3 mg and 40 in 1700 micrograms group) were comparable in age, period of gestation, indications for induction of labour and in their initial cervical score. The number of patients who started labour with a two dose schedule 4 hours apart were similar in each group. The improvement of cervical score, length of labour, mode of delivery and the neonatal outcome were not different in the two groups. There was no advantage of using a film preparation over that in the form of a pessary and the use of 3 mg dose did not give significantly better results compared with the 1700 micrograms dose, in terms of obstetric or neonatal outcome.

Adult↗

PubMed1979

Prostaglandin E, pessaries for induction of labour.

Vaginal pessaries containing 3 mg of prostaglandin E2 were used to induce labour in 200 patients with variable induction features. Prostaglandin-induced labour was augmented where necessary by synthetic oxytocin. There was on failed induction. Only 23% of patients with favourable induction features and 53% of patients with unfavourable features needed oxytocin. There were no adverse fetal or maternal effects. The prostaglandin E2 pessary was as effective in inducing labour as 350 microgram extra-amniotic prostaglandin E2 in tylose in a comparable group of 200 patients in which there were 4 failed inductions.

Animals↗

PubMed1999

Urosepsis associated with vaginal pessary use.

Conservative management of genital prolapse in older women uses vaginal pessaries. Infectious complications of these devices, attributable in some instances to poor routine maintenance, are uncommonly reported. We present 2 cases of genitourinary sepsis associated with unsuspected pessary use and discuss the spectrum of complications reported with these appliances.

Aged↗

PubMed2003

Case study: challenges of pessary management.

Genital prolapse is the relaxation of the supporting structures of the pelvic floor. Significant morbidity can be associated if left untreated. Patients can elect to have surgical repair of their prolapse or use a pessary. The more significant the pelvic organ prolapse the more difficult it is to manage with pessary support. The case study in this article describes such a patient and the challenges we faced with managing her advanced genital prolapse.

Aged↗