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1.  Exfoliative Dermatitis after Acetarsol Vaginal Pessaries 
British Medical Journal  1954;2(4892):850-851.
PMCID: PMC2079486  PMID: 13199327
The journal of sexual medicine  2015;12(12):2339-2349.
Pessaries are commonly used to treat pelvic floor disorders, but little is known about the sexual function of pessary users.
We aimed to describe sexual function among pessary users and pessary management with regard to sexual activity.
This is a secondary analysis of a randomized trial of new pessary users, where study patients completed validated questionnaires on sexual function and body image at pessary fitting and 3 months later.
Main outcome measures
Women completed the Pelvic Organ Prolapse - Urinary Incontinence Sexual Function Questionnaire, IUGA Revised (PISQ-IR), a validated measure that evaluates the impact of pelvic floor disorders on sexual function, a modified female body image scale (mBIS), and questions regarding pessary management surrounding sexual activity.
Of 127 women, 54% (68/127) were sexually active at baseline and 42% (64/114) were sexually active at 3 months. Sexual function scores were not different between baseline and 3 months on all domains except for a drop of 0.15 points (p=0.04) for sexually active women and a drop of 0.34 points for non-sexually active women (p=0.02) in the score related to the sexual partner. Total mBIS score did not change (p=0.07), but scores improved by 0.2 points (p=0.03) in the question related to self-consciousness. Pessary satisfaction was associated with improved sexual function scores in multiple domains and improved mBIS scores. The majority (45/64, 70%) of sexually active women removed their pessary for sex, with over half stating their partner preferred removal for sex (24/45, 53%).
Many women remove their pessary during sex for partner considerations, and increased partner concerns are the only change seen in sexual function in the first 3 months of pessary use. Pessary use may improve self-consciousness and pessary satisfaction is associated with improvements in sexual function and body image.
PMCID: PMC4957547  PMID: 26632106
Pessaries; sexual function; sexual activity; body image; partner; remove; hygiene
7.  Association of Progesterone, Pessary, and Antibiotic for Treating Pregnant Woman with Short Cervix Syndrome: Importance of Magnetic Resonance Imaging in the Assessment of Pessary Position 
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, the fetus presented distress (tachycardia). C-section was performed, producing a live female newborn weighing 2,180 g and presenting Apgar indexes of 8/8. This case report demonstrates the importance of magnetic resonance imaging to assess the position of pessary in a pregnant woman with short cervix.
PMCID: PMC3779391  PMID: 24083064
Magnetic resonance imaging; pessary; preterm delivery; progesterone; short cervix syndrome; ultrasound
PMCID: PMC1657340  PMID: 18741275
10.  Complication of Self-treatment with Ring Pessary 
British Medical Journal  1964;2(5408):554.
PMCID: PMC1816168  PMID: 14173190
11.  Retention of Silkworm-Gut Pessary 
PMCID: PMC1659085  PMID: 18742834
16.  Acute Systemic Reaction to Acetarsol 
British Medical Journal  1956;2(5008):1528-1529.
PMCID: PMC2036064  PMID: 13374373
17.  Cervical pessaries for prevention of spontaneous preterm birth: past, present and future 
This Review describes the rationale for the use of cervical pessaries to prevent spontaneous preterm birth and their gradual introduction into clinical practice, discusses technical aspects of the more commonly used designs and provides guidance for their use and future evaluation. Possible advantages of cervical pessaries include the easy, ‘one-off’ application, good side-effect profile, good patient tolerance and relatively low cost compared with current alternatives. Use of transvaginal sonography to assess cervical length in the second trimester allows much better selection of patients who may benefit from the use of a cervical pessary, but future clinical trials are needed to establish clearly the role of pessaries as a preterm birth prevention strategy worldwide.
PMCID: PMC4282542  PMID: 23775862
cervical pessary; polyclinic setting; spontaneous preterm birth; transvaginal sonography in obstetrics
18.  Plasma metronidazole concentrations after single and repeated vaginal pessary administration. 
Metronidazole concentrations in plasma were measured by h.p.l.c. in 12 healthy female volunteers after single and repeated vaginal administration of 500 mg metronidazole pessaries. The area under the plasma concentration-time curve (AUC(0,12 h) was 8.4 +/- 3.9 micrograms ml-1 h (mean +/- s.d.) on day 1 and 20.6 +/- 7.1 micrograms ml-1 h (mean +/- s.d.) on day 5. The peak plasma drug concentration on day 1 was 1.2 +/- 0.6 micrograms ml-1 (mean +/- s.d.) and on day 5 it was 2.0 +/- 0.7 micrograms ml-1 (mean +/- s.d.). The plasma concentration of metronidazole at steady state was above the minimum inhibitory concentration (MIC) for anaerobic Streptococci and Clostridium tetani. These results demonstrate much lower systemic exposure than after oral administration.
PMCID: PMC1368641  PMID: 1954077
19.  Systemic absorption of ketoconazole from vaginal pessaries. 
Eight healthy female subjects were each given (a) ketoconazole 400 mg orally, (b) ketoconazole 400 mg as a single vaginal pessary, (c) ketoconazole 800 mg as two vaginal pessaries, and (d) ketoconazole 1200 mg as three vaginal pessaries. The area under the plasma concentration time curve (AUC) after the oral dose was 51.41 +/- 10.99 mg l-1 h (mean +/- s.d.) and the half-life of ketoconazole was 2.98 +/- 1.41 h. The AUCs after vaginal administration were 0.27 +/- 0.14, 0.52 +/- 0.25, and 0.43 +/- 0.22 mg-1 l h following the 400, 800 and 1200 mg pessaries respectively. Systemic absorption of single doses of vaginally administered ketoconazole appears to be negligible in the absence of vaginal infection. There were no local or systemic side effects related to ketoconazole in these healthy volunteers.
PMCID: PMC1463314  PMID: 6322829
20.  A nationwide survey concerning practices in pessary use for pelvic organ prolapse in The Netherlands: identifying needs for further research 
International Urogynecology Journal  2015;26(10):1453-1458.
Introduction and hypothesis
To identify practice variation in management of patients with a vaginal pessary for pelvic organ prolapse (POP).
A nationwide survey was sent to all Dutch gynecologists with a special interest in urogynecology.
The response rate was 59 %. Of the respondents, 13 % had a written protocol for pessary treatment in their department. Pessary treatment was proposed by 69 % of respondents as a treatment option. Counseling about side effects varied. All respondents provided information concerning the possibility of serious vaginal discharge. Concerning this side effect, 15 % of the respondents stated that it occurs in 5 – 20 % of patients, 27 % that it occurs in 20 – 40 % of patients, and 57 % that it occurs in more than 40 % of patients. Another item concerned counseling for the likelihood of vaginal blood loss. All respondents provided information concerning the possibility of vaginal blood loss. Concerning this side effect, 53 % of the respondents stated that it occurs in 5 – 20 % of patients, 33 % that it occurs in 20 – 40 %, and 14 % that it occurs in more than 40 % of patients. Follow-up after initial placement was done by 69 % of the respondents at 2 – 6 weeks, by 2 % at 8 weeks, and by 29 % at 12 weeks or more. Most (98 %) of the respondents extended the interval between visits when the patient had no complaints, and 96 % of the respondents reported that they routinely instruct patients about self-management.
Pessaries are suggested as a treatment option by a majority of gynecologists, but practice varies widely. We consider that the variation in practice is due to a lack of available protocols and lack of evidence.
PMCID: PMC4575368  PMID: 26063547
Prolapse; Pessary; Survey; Prolapse management
21.  Adjunctive Pessary Therapy after Emergency Cervical Cerclage for Cervical Insufficiency with Protruding Fetal Membranes in the Second Trimester of Pregnancy: A Novel Modification of Treatment 
BioMed Research International  2015;2015:185371.
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, although the differences are not statistically significant. Further prospective study is required to prove these findings.
PMCID: PMC4564585  PMID: 26413506
22.  Innovative Approach for Interstitial Cystitis: Vaginal Pessaries Loaded Diazepam—A Preliminary Study 
Journal of Pharmaceutics  2013;2013:386546.
Bladder pain is a characteristic disorder of interstitial cystitis. Diazepam is well known for its antispasmodic activity in the treatment of muscular hypertonus. The aim of this work was to develop and characterize vaginal pessaries as an intravaginal delivery system of diazepam for the treatment of interstitial cystitis. In particular, the performance of two types of formulations, with and without beta-glucan, was compared. In particular, the preparation of pessaries, according to the modified Pharmacopeia protocol, the setup of the analytical method to determine diazepam, pH evaluation, dissolution profile, and photostability assay were reported. Results showed that the modified protocol permitted obtaining optimal vaginal pessaries, without air bubbles, with good consistency and handling and with good pH profiles. In order to determine the diazepam amount, calibration curves with good correlation coefficients were obtained, by the spectrophotometric method, using placebo pessaries as matrix with the addition of diazepam standard solution. This method was demonstrated sensible and accurate to determine the amount of drug in batches. Dissolution profiles showed a complete diazepam release just after 15 minutes, even if beta-glucan pessaries released drug more gradually. Finally, a possible drug photodegradation after exacerbated UV-visible exposition was evaluated.
PMCID: PMC4590789  PMID: 26555976
23.  The Effect of Trimosan© Gel on Pessary-Associated Bacterial Vaginosis: A Multi-Center, Randomized, Controlled Trial 
Pessaries are important options for women with pelvic floor disorders, but many pessary users experience bacterial vaginosis (BV). The aim of this study was to evaluate the effect of TrimoSan© gel on BV prevalence among pessary users.
Study Design
Women presenting for a pessary fitting completed questionnaires on vaginal symptoms and hormone therapy (HT) use and underwent a BV® BLUE test and slide collection for BV analysis by Nugent's criteria. Following pessary fitting, women were randomized to either standard pessary care with the use of TrimoSan© placed vaginally twice weekly or to standard pessary care without TrimoSan© gel. Women returned 2 weeks and 3 months later for repeat slide collection for Gram stain, BV® BLUE testing, and completion of questionnaires on vaginal symptoms and desire to continue the pessary.
There were 184 women randomized after successful fitting (92 to the TrimoSan© group), and 147 (79%) presented for 3 month follow up. Mean age was 56 ± 16 years; patients were mostly Caucasian (57%) or Hispanic (23%) and 36% were using HT. The groups did not differ in the prevalence of BV by Nugent's criteria at 2 weeks (20% TrimoSan© vs 26% no gel, p=0.46) or 3 months (24% TrimoSan© vs 23% no gel, p=0.82), nor did they differ in BV by BV® BLUE testing at 2 weeks (0%TrimoSan©vs 4% no gel, p=0.12) or 3 months (3% TrimoSan© vs 0% no gel, p=0.15). The prevalence of at least one vaginal symptom did not differ between groups at 2 weeks (44% TrimoSan© vs 45% no gel, p=0.98) or 3 months (42% TrimoSan© vs 32% no gel, p=0.30). The TrimoSan© group was equally likely to want to continue their pessary use compared to the standard care group at 2 weeks (90% vs 86%, p=0.64) and 3 months (63% vs 60%, p=0.76).
TrimoSan© gel in the first 3 months of pessary use does not decrease the prevalence of BV or vaginal symptoms and does not alter the likelihood of a woman desiring to continue pessary use.
PMCID: PMC4627896  PMID: 25935783
pessary; bacterial vaginosis; TrimoSan; discharge; removal
24.  Safety evaluation of Phytovagex, a pessary formulation of Nigella sativa, on pregnant rats 
The possible toxicity of drugs in pregnancy should be tested before their use in pregnant patients. In the present study, we aimed to evaluate the safety of phytovagex, a pessary formulation of Nigella sativa (N. sativa), which is already in clinical use for vaginal fungal infection.
Materials and Methods:
The pregnant rats were treated intravaginal with physiological saline (vehicle) or phytovagex pessary in the first half of their pregnancy (days 1 to 10 of gestation). Duration of pregnancy and health parameters of the newborns were recorded after parturition. Also, cytotoxicity of N. sativa hydroalcoholic extract was tested against ovary Cho cells.
The phytovagex had no significant effect on the duration of pregnancy, number of newborns, weight of neonates, and percent of stillbirth. No deformity or general behavioral abnormality was observed in neonates monitored for 30 days after birth. N. sativa extract had no significant effect on the viability of ovary cells at the concentrations of 12.5-200 µg/mL.
Results of this animal study showed that phytovagex has no overall effect on the duration of pregnancy and health parameters of the newborns. Also, its active agent, N. sativa, does not induce any cytotoxic effect on ovary cells.
PMCID: PMC4884224  PMID: 27247929
Nigella sativa; Pregnancy; Rat; Stillbirth
25.  Accounting for treatment by center interaction in sample size determinations and the use of surrogate outcomes in the pessary for the prevention of preterm birth trial: a simulation study 
Trials  2016;17:310.
The Pessary for the Prevention of Preterm Birth Study (PS3) is an international, multicenter, randomized clinical trial designed to examine the effectiveness of the Arabin pessary in preventing preterm birth in pregnant women with a short cervix. During the design of the study two methodological issues regarding power and sample size were raised. Since treatment in the Standard Arm will vary between centers, it is anticipated that so too will the probability of preterm birth in that arm. This will likely result in a treatment by center interaction, and the issue of how this will affect the sample size requirements was raised. The sample size requirements to examine the effect of the pessary on the baby’s clinical outcome was prohibitively high, so the second issue is how best to examine the effect on clinical outcome. The approaches taken to address these issues are presented.
Simulation and sensitivity analysis were used to address the sample size issue. The probability of preterm birth in the Standard Arm was assumed to vary between centers following a Beta distribution with a mean of 0.3 and a coefficient of variation of 0.3. To address the second issue a Bayesian decision model is proposed that combines the information regarding the between-treatment difference in the probability of preterm birth from PS3 with the data from the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study that relate preterm birth and perinatal mortality/morbidity. The approach provides a between-treatment comparison with respect to the probability of a bad clinical outcome. The performance of the approach was assessed using simulation and sensitivity analysis.
Accounting for a possible treatment by center interaction increased the sample size from 540 to 700 patients per arm for the base case. The sample size requirements increase with the coefficient of variation and decrease with the number of centers. Under the same assumptions used for determining the sample size requirements, the simulated mean probability that pessary reduces the risk of perinatal mortality/morbidity is 0.98. The simulated mean decreased with coefficient of variation and increased with the number of clinical sites.
Employing simulation and sensitivity analysis is a useful approach for determining sample size requirements while accounting for the additional uncertainty due to a treatment by center interaction. Using a surrogate outcome in conjunction with a Bayesian decision model is an efficient way to compare important clinical outcomes in a randomized clinical trial in situations where the direct approach requires a prohibitively high sample size.
PMCID: PMC4932689  PMID: 27378231
Treatment by center interaction; Sample size requirements; Bayesian decision models; Surrogate outcomes

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