Objective: To evaluate the efficacy and tolerability of a vaginal pessary containing 750 mg of metronidazole and 200 mg of miconazole nitrate used daily for 7 days in the treatment of vaginitis. Methods: Ninety-two women with vaginitis participated in this phase 3 study using one vaginal pessary daily for 7 days. Gynecological and microbiological evaluations were carried out prior to and following treatment. Results: Reductions occurred in symptoms and signs of vaginitis. Clinical cure rate was 87.7%, while the cure rates according to microscopy and Candida albicans culture were 81.8% and 73.9%, respectively. The cure rate for bacterial vaginosis was 75% and culture of Gardnerella vaginalis turned negative in 63.6% of cases following treatment. The medication was well tolerated. Conclusion: Use of a combination of 750 mg of metronidazole and 200 mg of miconazole in a single daily application was found to be effective in the treatment of the most common causes of vaginitis. (c) 2008 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
A clinical investigation was undertaken to determine if chemoprophylaxis in the form of a contraceptive pessary would reduce the rate of reinfection with gonorrhoea in 1245 female patients attending a venereal disease clinic. After the introduction of the pessary the reinfection rate over a 16-week period was 19% compared with 40% in the control clinic patients. It was also found that women could be motivated to use a pessary; 65% of women used pessaries before sexual intercourse at least some of the time. High reinfection rates in venereal disease clinic patients emphasise the need for improved methods of preventing reinfection. Vaginal chemoprophylaxis appears to be an alternative means of reducing gonorrhoea morbidity.
In a double-blind study the therapeutic efficacy of a single 500-mg clotrimazole pessary was compared with that of a 200-mg clotrimazole pessary inserted once daily for three days in 72 patients with vaginal candidosis confirmed by culture. On clinical assessment four weeks after completion of treatment with the single-dose pessary the cure rate was 86% compared with 92% after the three-day regimen. There was no significant difference in the eradication rate between the single-dose (94%) and three-day regimens (89%). Four weeks after completion of treatment the recurrence rates by culture were 18% with the single-dose and 24% with the three-day regimen. The former treatment was well tolerated and as effective as the three-day clotrimazole regimen.
The effect of antifungal therapy on the vaginal microbial flora was studied in 23 patients suffering from culture-positive, symptomatic vaginal candidosis. They were randomly allocated to receive either a 500 mg clotrimazole vaginal pessary or a 150 mg fluconazole capsule. Quantitative microbiological examination was carried out on samples of vaginal secretions obtained prior, and at intervals up to 10 days after, treatment. No significant difference was found in the vaginal flora before or after therapy in individual patients or between the treatment groups. In patients with C glabrata or C krusei, the yeasts persisted longer in the vagina with poorer response to either of the medications.
A new polymer vaginal pessary providing sustained constant release of prostaglandin E2 was administered to 66 patients before planned induction of labour. Effective ripening of the unfavourable cervix was achieved in each of 18 primigravidas, in eight of whom labour was initiated without further treatment. When the cervix was moderately favourable the need for orthodox induction of labour was obviated in 16 out of 23 primigravidas and 21 out of 23 multigravidas. This method of sustained release of prostaglandin E2 is simple and convenient and readily acceptable to the patient; it is an important step in the development of non-invasive methods of inducing labour.
Vaginal pessaries still have a role in the management of uterine prolapse, particularly in elderly patients. However, they are known to cause serious complications if proper care is not taken. We present a case of a rectovaginal fistula, developing secondary to a forgotten vaginal pessary. The shelf pessary was found to have eroded through into the rectum. A review of the relevant literature was undertaken and complications associated with vaginal pessaries are discussed.
In Africa, the use of traditional herbal remedy is widespread. Acute renal failure (ARF) is one of the most serious complications. The use of herbal remedies (mostly orally) accounts for nearly 35% of all cases of acute renal failure in Africa. Development of renal failure following herbal vaginal pessary is rarely reported. In November 2003, a 35-year-old Nigerian female who is a petty trader and a primary school leaver with three children (all males) presented to us in the renal unit with oliguric ARF induced by herbal vaginal pessary. She had sought this alternative medicine in an attempt to have a female child as all her three children are males. Her condition was managed accordingly and required three sessions of hemodialysis. She started diuresing on the eighth day of admission. This case presentation highlights the potential tragedies of herbal preparation, of note, that herbal vaginal pessaries are as deleterious as the oral preparations, and that the dilemma of ignorance is still prevalent in our society.
With the aging population in the United States, there has been a renewed interest in pessaries as a conservative alternative to surgical repair for pelvic organ prolapse (POP). They present a good option for patients who have not completed childbearing, do not desire surgery, or are poor surgical candidates. Long-term pessary use is a safe and effective option for patients with POP and stress urinary incontinence. Although serious side effects are infrequent, insertion and removal of most pessary types still pose a challenge for many patients. Pessary design should continue to improve, making its use a more attractive option.
Pessaries have been used to treat women with pelvic organ prolapse (POP) since the beginning of recorded history. This review aims to assess the effect of pessary treatment on the disease-specific, health-related quality of life in women with pelvic organ prolapse. After a Medline search using the Mesh term ‘pessary’ and critical appraisal, 41 articles were selected and used in this review. Pessaries are widely used to treat pelvic organ prolapse. It is minimally invasive and appears to be safe. Although there is evidence that the use of pessaries in the treatment of pelvic organ prolapse is effective in alleviating symptoms and that patient satisfaction is high, the follow-up in many published papers is short, and the use of validated urogynaecological questionnaires is limited. Comparison with surgical treatment of pelvic organ prolapse is rare and not assessed in a randomised controlled trial.
Introduction. Reduction of preterm birth is a major goal in obstetric care. We performed a systematic review of randomized controlled trials and cohort studies on the effectiveness of the cervical pessary to prevent preterm birth. Methods. We searched the electronic databases of MEDLINE and Embase from inception until April 2012 to identify studies investigating treatment with a cervical pessary to prevent preterm birth. We constructed two-by-two tables for delivery before 28, 34, and 37 weeks of gestation and calculated relative risks (RRs) with 95% confidence intervals. Results. The search revealed 103 potentially eligible abstracts of which six cohort studies and four randomized controlled trials (RCTs) investigated the effectiveness of the pessary. One RCT (n = 380) demonstrated a lower delivery rate prior to 34 weeks (RR 0.24; 95% CI 0.13–0.43) in the pessary group, while another RCT (n = 108) showed no positive effect of pessary for delivery before 34 weeks (RR 1.73; 95% CI 0.43–6.88). Two older quasi randomized studies and cohort studies indicated potential effect of the pessary. Conclusions. Available randomized and nonrandomized studies indicate potential effectiveness of a cervical pessary in the prevention of preterm birth. More randomized clinical trials are needed before this device can be used in clinical practice.
A 35-year-old gravida 7, para 1, and abortus 5 female with hypogastric pain and inability to void urine after 14 + 3 weeks of amenorrhea was examined in the emergency department. One year before, a uterine prolapse had been diagnosed in another hospital. Examination showed a uterine prolapse grade 2 with palpable bladder. The patient was unable to void urine. After a manual reduction of the uterine prolapse, the patient underwent an emergency catheterization for bladder drainage. A Hodge pessary (size 70) was placed, which led to spontaneous micturitions. Due to the persistence of the symptoms the following day, Hodge pessary was replaced by an Arabin cerclage pessary. Although the pessary could be removed from the beginning of the second trimester, due to the uterine prolapse as a predisposing factor in the patient and the uncomplicated progression of pregnancy, it was decided to maintain it in our patient. Therefore, Arabin cerclage pessary allowed a successful pregnancy outcome and was not associated with threatened preterm delivery or vaginal infection.
Preterm delivery (PD) is the most important cause of neonatal mortality, particularly before the 32nd week of pregnancy. A short cervix is the most important quantitative marker for predicting PD. However, there are other qualitative markers such as cervical gland area, cervical funneling, and sludge. We present the case of a pregnant woman who was diagnosed with a short cervix at 14-weeks and demonstrate the use of triple therapy, which helped to achieve a good perinatal result. A 37-year-old pregnant woman (G3P0) was referred to our service at 14-weeks of pregnancy presenting with a short cervix (20 mm) and a positive sludge sign. She was hospitalized; a pessary was inserted, and started on antibiotic therapy (clindamycin and cefalotin for 10 days). At 20 weeks, she was again admitted to the hospital, and this time presented with a further shortened cervix (9 mm), cervical funneling, and a positive sludge sign, with the pessary in position. The following procedures were performed: Amniocentesis on the sludge (negative bacterioscopy), another cycle of antibiotics, administration of oral progesterone, and imaging to determine retention of pessary position. The patient was placed in the Trendelenburg position and remained hospitalized for 82 days. At 32 + 1 weeks...
Objective: Patients with a history of one or more conizations have an increased risk of spontaneous preterm birth (SPTB). The aim of this study was to investigate the outcome of pregnancies in patients with a history of conization and early treatment with a cervical pessary. Methods: In this pilot observational study we included 21 patients and evaluated the obstetric history, the interval between pessary placement and delivery, gestational age at delivery, the neonatal outcome and the number of days of maternal and neonatal admission. Results: Among the study group of 21 patients, 20 patients had a singleton and one had a dichorionic/diamniotic twin pregnancy. At insertion, the mean gestational age was 17 + 2 (10 + 5–24 + 0) weeks and the mean cervical length was 19 (4–36) mm. Six patients presented with funneling at insertion with a mean funneling width of 19.7 (10–38) mm and funneling length of 19.9 (10–37) mm. Five patients had already lost at least one child due to early spontaneous preterm birth and another five had at least one previous abortion, who have now delivered beyond 34 weeks. The mean gestational age at delivery was 38
(31 + 1–41 + 0) gestational weeks and the mean interval between insertion and delivery was 145 (87–182) days. Conclusion: Our findings suggest a beneficial effect of an early pessary placement for patients at high-risk for preterm birth due to conization.
Aim. To evaluate the effectiveness of adjunctive pessary therapy after emergency cervical cerclage (ECC) in improving perinatal outcome in cervical insufficiency with fetal membranes protruding into the vagina. Material and Methods. A retrospective analysis of patients treated at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, between 2008 and 2013. The study group consisted of 15 women treated with ECC and a pessary and the control group consisted of 17 patients treated with cerclage only. Results. The mean gestational age at delivery was significantly higher in the study group (34.7 versus 29.7 weeks, p = 0.03). The period between cerclage insertion and delivery was significantly longer in the study group (82.9 versus 52.1 days, p = 0.045). The mean neonatal birthweight and neonatal “discharge alive” ratio were higher in the study group, although not statistically significant (2550 g versus 1883 g, p = 0.14, and 93.3% versus 70.5%, p = 0.18, resp.). NICU hospitalization rates were comparable (33.3% versus 35.3%, p = 0.9). Conclusions. Adjunctive pessary therapy allows delaying delivery in women treated with ECC due to cervical insufficiency with protruding fetal membranes. It also seems to improve neonatal outcome...
Hegeman, M.; Bekedam, D.; Bloemenkamp, K.; Kwee, A.; Papatsonis, D.; van der Post, J.; Lim, A.; Scheepers, L.; Willekes, C.; Duvekot, J.; Spaanderman, M.; Porath, M.; van Eyck, J.; Haak, M.; van Pampus, M.; Bruinse, H.; Mol, B.
BACKGROUND Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. METHODS/DESIGN We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first. The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit...
Introduction. Reduction of preterm birth is a major goal in obstetric care. We performed a systematic review of randomized controlled trials and cohort studies on the effectiveness of the cervical pessary to prevent preterm birth. Methods. We searched the electronic databases of MEDLINE and Embase from inception until April 2012 to identify studies investigating treatment with a cervical pessary to prevent preterm birth. We constructed two-by-two tables for delivery before 28, 34, and 37 weeks of gestation and calculated relative risks (RRs) with 95% confidence intervals. Results. The search revealed 103 potentially eligible abstracts of which six cohort studies and four randomized controlled trials (RCTs) investigated the effectiveness of the pessary. One RCT (n = 380) demonstrated a lower delivery rate prior to 34 weeks (RR 0.24; 95% CI 0.13-0.43) in the pessary group, while another RCT (n = 108) showed no positive effect of pessary for delivery before 34 weeks (RR 1.73; 95% CI 0.43-6.88). Two older quasi randomized studies and cohort studies indicated potential effect of the pessary. Conclusions. Available randomized and nonrandomized studies indicate potential effectiveness of a cervical pessary in the prevention of preterm birth. More randomized clinical trials are needed before this device can be used in clinical practice.; Sophie M. S. Liem...
Background: In women with a multiple pregnancy, spontaneous preterm delivery is the leading cause of perinatal morbidity and mortality. Interventions to reduce preterm birth in these women have not been successful. We assessed whether a cervical pessary could effectively prevent poor perinatal outcomes. Methods: We undertook a multicentre, open-label randomised controlled trial in 40 hospitals in the Netherlands. We randomly assigned women with a multiple pregnancy between 12 and 20 weeks' gestation (1:1) to pessary or control groups, using a web-based application with a computer-generated list with random block sizes of two to four, stratified by hospital. Participants and investigators were aware of group allocation. For women in the pessary group, a midwife or obstetrician inserted a cervical pessary between 16 and 20 weeks' gestation. Women in the control group did not receive the pessary, but otherwise received similar obstetrical care to those in the pessary group. The primary outcome was a composite of poor perinatal outcome: stillbirth, periventricular leucomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular haemorrhage, necrotising enterocolitis, proven sepsis, and neonatal death. Analyses were by modified intention to treat. This trial is registered in the Dutch trial registry...
Objective. We evaluated the use of a one-week ambulatory pessary trial in predicting patients' postoperative outcomes for occult stress incontinence.
Methods. Patients with anterior vaginal wall prolapse were offered a pessary trial to predict response to reconstruction. We performed a retrospective review of 4 years of cases. All patients underwent a detailed evaluation including videourodynamics with and without pessary reduction.
Results. Twenty-six patients completed the 1-week pessary trial. Ten (38%) women showing no evidence of stress urinary incontinence (SUI) underwent surgical repair of prolapse without anti-incontinence procedure. None of these patients had SUI postoperatively. Sixteen women (61%) had occult stress urinary incontinence on evaluation and underwent concurrent sling procedure. Three (19%) of these patients were identified by the pessary trial alone. Twenty-five of the 26 patients were without clinical stress incontinence at a mean follow up of 12 months (range 4–37 months). The pessary trial correctly predicted persistent urgency in six patients and persistent frequency in five. No patients with SUI or persistent voiding difficult were missed in a pessary trial.
Conclusion. An ambulatory pessary trial is an effective...
Abstract not available; S. M. S. Liem, G. J. van Baaren, F. M. C. Delemarre, I. M. Evers, G. Kleiverda, A. J. van Loon, J. Langenveld, N. Schuitemaker, J. M. Sikkema, B. C. Opmeer, M. G. van Pampus, B. W. J. Mol and D. J. Bekedam; Article first published online: 7 AUG 2014