Pessary Research Articles

Learnings From an Innovative Model to Expand Access to a New and Underutilized Nonhormonal Contraceptive Diaphragm.

We document the effort over the last 30 years to respond to the call by women advocates at the International Conference on Population and Development for more woman-initiated single or dual-purpose contraceptive methods by developing the Caya contoured diaphragm, an innovative diaphragm designed to meet the needs of women and their partners and expand options for nonhormonal barrier contraception. We describe the complex and interrelated set of activities undertaken to develop the product using a human-centered design process and how we are working to create a corollary sustainable market. This review includes the evidence generated around improved acceptability among couples in low- and middle-income countries and depicts challenges and practical actions on how to dispel misconceptions about diaphragm use. Importantly, we share programmatic lessons learned on increasing universal access to this new sexual and reproductive health technology. Following our new model for increasing access to new and underutilized methods, Caya is now registered and being marketed in nearly 40 countries worldwide.

Long-term continuations rate of ring pessary use for symptomatic pelvic organ prolapse.

To evaluate long-term continuation rates, adverse events of ring pessary use at a minimum of 5years follow-up, and factors associated with discontinuation in symptomatic pelvic organ prolapse (POP). Women with symptomatic POP who were treated with vaginal ring pessary and had successful fittings were included. Adverse events and reasons for discontinuation of pessary use were recorded. Patients who were lost to follow-up were defined as discontinuation. During 12year-period, 239 of 329 POP patients (72.6%) had successful fittings with ring pessary. The mean age was 67.8 ± 8.9years (range 27-86) and 70% of patients had advanced stage. The cumulative probability of continued ring pessary use was 84.1%, 64.4%, 49.3%, and 33.5%, at 1, 3, 5, and 10years, respectively. Most common reason for discontinuation was frequent expulsion (21.6%), followed by vaginal erosion (16.5%), no prolapse improvement (12.4%), and inability or inconvenience to do self-care (9.3%). However, 9 patients (9.3%) had improvement of prolapse and were able to discontinue pessary insertion. Age above 70years, wide introitus, and incapability of self-care are independent factors associated with long-term discontinuation. Adverse events occurred in 23.4% of patients, 18.8% of them had vaginal erosion, 11.7% vaginal discharge/infection, and 18.4% de novo SUI. However, no statistical significance existed between those who continued and discontinued pessary use due to these adverse events. Ring pessary is an effective treatment in symptomatic POP, with acceptable long-term continuation rates and minor adverse events. Self-care of pessary is very important aiming to minimize adverse events. Advanced age, wide introitus and incapability of self-care were associated factors for long-term discontinuation.

Vaginal Cancer: Association with long term use of Pessary in Pelvic Organ Prolapse

Vaginal cancer, rarest form of gynaecological cancer (0.6%) has been found to be associated with long term use of vaginal ring pessary, which have long been used in alternative management of pelvic organ prolapse (POP) other than surgery. A through survey was done in remote areas of Cox’s bazar, refugee camp where out of 52 cases of pelvic organ prolapse, 7 cases found to use vaginal ring pessary for long and out of 7, vaginal cancer developed in 4 cases. All of them were aged women above 60 and had defaulted follow up presented with vaginal bleeding, varying discharge and pain of varying intensity. One patient had only local lesion was treated by surgical removal followed by radiotherapy. The 2 nd one, 68 years, received neo-adjuvant therapy and died before planned surgery. The 3 rd one, aged 79, did not come for follow up after diagnosis of vaginal cancer done and advised for definitive surgical treatment, family refused operation and she passed away after 2 years at 81 years. The 4 th one declined further investigations and any form of treatment once diagnosed with vaginal cancer. So, all patients of pelvic organ prolapse should be informed thoroughly (both verbal and written informed consent) before inserting pessary for potential long term serious consequences where strict compliance must be ensured for subsequent regular follow up and biopsy should be mandatory for any suspicious chronic vaginal ulcers among them. Bangladesh J Obstet Gynaecol, 2022; Vol. 37(1): 75-77

A review: patient questions about use of vaginal ring pessaries for prolapse

A review: patient questions about use of vaginal ring pessaries for prolapse

Does monthly self-management of vaginal ring pessaries reduce the rate of adverse events? A clinical audit.

ObjectiveTo determine the rate of adverse events (AE) in women who self-manage their vaginal ring pessary on a monthly basis. We hypothesised that the AE rate would be lower compared to previously published traditional management protocols.Study designAudit study of 75 women with pelvic organ prolapse and/or stress incontinence, who were fitted with a vaginal ring pessary during a five-year period, and who have self-managed their vaginal rings for at least two years, in a tertiary referral urogynaecology clinic.Main outcome measuresAEs included vaginal bleeding, malodorous vaginal discharge, extrusion of the device, pain/discomfort, and disorders of defaecation or de novo urinary incontinence. AEs that led to discontinuation of usage were termed “major”.ResultsOf the 75 women who were taught to self-manage their ring pessary, 68 were initially successful. At a median follow-up of 50.5 months [IQR 43–76 months; median 4.2 years], 36 women (52.9%) were still using their ring pessary. Five women (7.4%) had vaginal erosions and bleeding leading them to cease pessary use (four proceeded to surgery). Three minor AEs were identified (4.4%), resolving after discontinuation of ring use two weeks. Thus, the overall AE rate was 11.8% (8/68).ConclusionsIn contrast to previous published AE rates of 43–56% in women having ring changes at a clinic every 4–6 months, the AE rate was 12% in the women who performed monthly self-management of vaginal ring pessaries. Such information should be made available to patients considering a vaginal ring pessary.

A New Contraceptive Diaphragm in Niamey, Niger: A Mixed Methods Study on Acceptability, Use, and Programmatic Considerations.

Diaphragms have never been widely available in West Africa, a region with very low contraceptive use due in part to health system constraints and low demand for other modern methods of contraception. Research has demonstrated the single-size Caya contoured diaphragm to be a safe and effective barrier method of nonhormonal, self-care contraception, offering features that improve upon the design of traditional diaphragms. No studies have measured continuation of Caya. In Niamey, Niger, this pilot introduction study explored Caya acceptability, use, and programmatic considerations. Women in Niger participated in surveys (n=150) and in-depth interviews (n=25) 6 months after adopting Caya. In-depth interviews were also conducted with men in the community (n=15) and family planning providers (n=15). We conducted descriptive analysis of the percentage of adopters who continued to use the method at 6 months and women's reasons for discontinuation among women who completed the 6-month follow-up survey. We used deductive thematic analysis of in-depth interview data from women, men, and providers to understand program elements and other factors associated with acceptability. Six months after initiation, 76.7% (95% confidence interval=0.70, 0.83) of 150 survey respondents reported continued use of Caya. Top reasons for use included: Caya causes no side effects for most users, works on demand, and is reusable for up to 2 years. Roughly one-quarter of women interviewed reported inconsistent use. Some men supported their partner's use; in other cases, women used Caya without informing or involving their partners. Providers described Caya as compatible with the needs of many women and credited pelvic models with enabling effective counseling. The Caya diaphragm has the potential to be a valuable addition to the range of contraceptive options, especially in settings with high levels of opposition to other modern methods.

Rectovaginal Fistula Due to an Erosive Pessary: A Case Report

Background: Pelvic organ prolapse (POP) occurs when pelvic organs protrude through the vagina due to displacement from their normal anatomic position, as a result of a weakening of the pelvic muscles. Pessaries have long been used to treat POP, but they may result in rectovaginal fistulas as a rare complication. The Case: We report a rare case of a rectovaginal fistula following vaginal ring pessary use in an 82-year-old G7P7 woman. She had a past medical history of bipolar disorder, and initially presented for nursing care and psychiatric support. A trained psychologist evaluated her, and found no psychological morbidity. A two-day history of a fall, diffuse abdominal pain, and chronic urinary incontinence were rather identified. Gynecological pelvic examination revealed a rectovaginal fistula and impacted stools in the vagina. Conclusion: The use of ring pessaries, though a conservative management option for POP, may lead to a rectovaginal fistula, a rare but severe complication.

Bacterial biofilm formation on vaginal ring pessaries used for pelvic organ prolapse.

The objective of this study was to characterize the bacterial biofilm on vaginal ring pessaries used to treat pelvic organ prolapse and investigate the relationship between biofilm phenotype and patient symptoms and clinical signs that are suggestive of inflammation. This was a cross-sectional observational study of 40 women wearing a ring-shaped pessary continuously for at least 12weeks. Participants underwent a clinical examination, and the pessary was removed. Clinical signs were recorded. A swab from the pessary surface and a high vaginal swab were collected from each woman. Participants completed a questionnaire on symptoms. Pessary biofilm presence and phenotype were determined by scanning electron microscopy (SEM). Vaginal and pessary bacterial composition was determined by 16S rRNA gene sequencing. The relationship between biofilm phenotype and symptoms and clinical signs was assessed using logistic regression. SEM confirmed biofilm formation on all 40 pessaries. Microbiota data were available for 25 pessary swabs. The pessary biofilm microbiota was composed of bacteria typically found in the vagina and was categorized into Lactobacillus-dominated (n= 10/25 pessaries, 40%) communities and Lactobacillus-deficient communities with high relative abundance of anaerobic/facultative anaerobes (n= 15/25 pessaries, 60%). While increasing age was associated with presence of a Lactobacillus-deficient pessary biofilm (odds ratio = 3.60, 95% CI [1.16-11.22], p= 0.04), no associations between biofilm microbiota composition and symptoms or clinical signs were observed. Lactobacillus-deficient biofilms commonly form on pessaries following long-term use. However, the contribution of biofilm phenotype to symptoms and clinical signs remains to be determined.

Pessaries for POP and SUI: Your options and guidance on use

Pessaries for POP and SUI: Your options and guidance on use

Retained pessary, causing strangulation of the uterus

On 19 / August 1893, the author was summoned to a 74-year-old patient who complained of the suffering caused to her by an unexplored pessary who had been lying for a long time, for six months.

Acceptance of ring pessary in pelvic organ prolapse

Aims: To evaluate the use of pessaries for women with Pelvic Organ Prolapse irrespectivve POP-Q stages.
 Method: This is retrospective study conducted at Paropakar maternity and Women’s hospital from mid April to mid December 2018 on 114 women with pelvic organ prolapse.
 Result: Total of 114 women with prolapse evaluated. Age of presentation ranged from 36 to 85 years. Twenty cases (17.6%) underwent prolapsed surgery and 71 cases (62.2%) had ring pessary.
 Conclusion: Overall acceptance of vaginal ring pessary is very high. It can be used in the majority of women with patient satisfaction and without noteworthy complication.

Effect of non-absorbent intravaginal menstrual/contraceptive products on Staphylococcus aureus and production of the superantigen TSST-1.

Tampons are associated with toxic shock syndrome (mTSS). One reason for this association is oxygen introduction within tampons into the anaerobic vagina. Oxygen is required for Staphylococcus aureus to produce TSS toxin-1 (TSST-1). There have been changes in use of medical devices to control menstrual flow, including increased use of menstrual discs and cups. These devices composed of solid, flexible materials do not absorb menstrual fluid and thus do not trap oxygen. This study evaluates tampons and non-absorbent devices for effect on S. aureus and TSST-1 production. There are three in vitro tests to evaluate devices for effect on TSST-1 production: (1) stationary flask, (2) shake flask, and (3) tampon sac. In this study, 100% rayon and 100% cotton tampons with three absorbencies, contraceptive diaphragms, and menstrual discs and cups were tested for effect on S. aureus growth and TSST-1 production. Product composition did not affect bacterial growth or TSST-1 production. Tampons showed no effect on S. aureus growth compared with no-tampon controls, but tampons showed enhanced TSST-1 production as a function of trapped oxygen in stationary cultures and tampon sacs but not in shake flasks. The non-absorbent devices showed no enhanced S. aureus growth or TSST-1 production compared with no-device controls. These studies are consistent with the association of tampons with mTSS as a function of absorbency, but they suggest the occasional association of mTSS with non-absorbent devices may be coincidental as opposed to co-causative.

The Use of a Vaginal Pessary to Decide Whether a Mid Urethral Sling should be Added to Prolapse Surgery.

Women with pelvic organ prolapse are at risk for stress urinary incontinence after prolapse surgery. Combining pelvic organ prolapse repair with anti-incontinence surgery reduces the incontinence rate but leads to overtreatment. Performing only pelvic organ prolapse repair leads to under treatment. Is a vaginal ring pessary a useful tool when deciding whether a mid urethral sling should be added to prolapse surgery? We performed a retrospective cohort study in women with symptomatic pelvic organ prolapse but without bothersome stress urinary incontinence who underwent vaginal prolapse repair between January 1, 2008 and December 31, 2017. Preoperatively a pessary was inserted in all women to detect occult stress urinary incontinence. If the pessary revealed bothersome stress urinary incontinence, a concomitant mid urethral sling was proposed. The primary outcome at followup was de novo stress urinary incontinence. Included in study were 220 women. After pessary insertion 132 women (60%) remained continent, 20 (9%) reported nonbothersome stress urinary incontinence and 68 (31%) had bothersome stress urinary incontinence. The latter group was offered combined surgery. At followup bothersome stress urinary incontinence was present in 12 of the 132 women (9%) who had been continent preoperatively and in 7 of the 20 (35%) who had had nonbothersome stress urinary incontinence. In 132 women who were continent with the pessary a total of 11 mid urethral sling procedures would have been needed to prevent postoperative stress urinary incontinence in 1 (number needed to treat was 11). In the 20 women who had nonbothersome stress urinary incontinence only 3 mid urethral sling procedures would have been necessary (number needed to treat was 3). In women with symptomatic pelvic organ prolapse a pessary is a useful tool when deciding whether to add a mid urethral sling.

A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel

ObjectivesTo evaluate a lactic-acid-containing diaphragm gel (Contragel®) approved outside the United States for use with a silicone rubber diaphragm (Caya®). The study gel is being evaluated as a safer alternative to nonoxynol-9 (N-9) gel, which has been associated with risk of increasing susceptibility to human immunodeficiency virus (HIV). Study designThis was a Phase I randomized, parallel study evaluating the safety of the novel diaphragm gel versus hydroxyethylcellulose (HEC) universal placebo gel delivered by the study diaphragm for two 7-day test cycles of daily use, without and with intercourse. The primary clinical safety endpoint was treatment emergent adverse events. Mucosal safety endpoints included colposcopic findings, anti-Escherichia coli activity of endocervical and vaginal fluid, immune mediators, Nugent score and ectocervical immune cell density. Endpoints were assessed prior to each test cycle and at day 7 of each test cycle. We compared the two independent groups and also evaluated paired changes from baseline in each gel cohort. ResultsTwenty-three participants used the study diaphragm with the novel gel (n=11) or with HEC (n=12). Use of either gel resulted in few genital AEs and no colposcopic findings. There were no differences in ectocervical histology and lymphocyte density or phenotype between the two cohorts at baseline or after each test cycle. We found no clinically important differences in the anti-microbial (anti Escherichia coli) activity of endocervical or vaginal fluid or concentrations of genital immune mediators (e.g. anti-inflammatory secretory leukocyte protease inhibitor (SLPI) or pro-inflammatory mediator RANTES) between the two gel cohorts at any visit. There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions. ConclusionsWe found no clinically significant differences in clinical and mucosal safety endpoints between the two cohorts. The mucosal safety profiles of the study gel and HEC placebo gel were similar. ImplicationsOur data demonstrate no clinically important differences between the safety profiles of the lactic-acid-containing diaphragm gel versus HEC placebo gel when used with the study diaphragm. N-9 can no longer be used with contraceptive diaphragms in high HIV prevalence regions. Although larger studies are needed, the novel gel appears safe for use with the study diaphragm, which is the first over-the-counter, non-hormonal, diaphragm.

The effect of time interval of vaginal ring pessary replacement for pelvic organ prolapse on complications and patient satisfaction: A randomised controlled trial

ObjectivesLimited data are available on the effect of the time interval of vaginal ring pessary replacement for pelvic organ prolapse (POP). This study investigated the effect of different replacement intervals on complications and patient satisfaction. Study designA double-blinded, randomized controlled trial was conducted in a tertiary urogynecology center. Women with a vaginal ring pessary for POP (stage I to IV) were randomly allocated to two groups: 3-monthly or 6-monthly ring pessary replacement. All women were blinded to the replacement interval. Investigators were blinded during outcome assessment. Subjects were followed up for 6 months. Main outcome measuresThe primary outcomes were the complication rates and patient satisfaction scores at 6 months. Secondary outcomes were the change in patient-reported symptoms and staging of POP. ResultsOf 101 women were screened from June 2016 to November 2017, 60 were recruited and randomly allocated: 30 to the 3-monthly replacement group and 30 to the 6-monthly replacement group. The overall complication rate in the 6-monthly group was higher than that in the 3-monthly group at the third visit (9 [30%] vs. 3[10.3%]; OR 3.71; 95%CI 0.89–15.58), but the difference was not statistically significant (p = 0.061). There were no statistically significant differences between groups in patient satisfaction scores, other prolapse-related symptoms or staging of POP. ConclusionsWe provide evidence on the effect of replacement interval for a vaginal pessary on complications and patient satisfaction. A higher complication rate was found in the 6-monthly group than in the 3-monthly group, although the difference was not statistically significant. Patient satisfaction scores were similar in both groups.

Perceived infertility and contraceptive use in the female, reproductive-age cancer survivor

To estimate the association between perceived fertility potential and contraception use and to characterize factors important in contraceptive decision making in reproductive-age, female cancer survivors. Cross-sectional study. Participants were from two state cancer registries, physician referrals, and cancer survivor advocacy groups in the United States. A total of 483 female survivors aged 18-40years. Online questionnaire. Contraception use. Eighty-four percent of participants used contraception; 49.7% used highly effective, World Health Organization tiers I and II methods (surgical sterilization, intrauterine devices, contraceptive implant, combined hormonal contraceptives, medroxyprogesterone acetate, progestin-only pills, contraceptive diaphragm). Contraception non-use was more common among survivors who perceived themselves to be infertile, compared with survivors who perceived themselves to be as or more fertile than similarly aged peers (prevalence ratio 4.0, 95% confidence interval 2.5-7.4). In mediation analysis that adjusted for clinical infertility, 59% of the association between prior chemotherapy and contraception non-use was explained by perceived infertility. Contraception efficacy (n = 62, 25.8%) and ease of use (n = 50, 20.8%) were the most cited reasons for using tier I/II methods; compared with lack of hormones (n = 81, 49.7%) as the predominant reason for using less-effective, tier III/IV methods. Although female, reproductive-age cancer survivors had high uptake of contraception, those who perceived themselves to be infertile were less likely to use contraception. Throughout survivorship, clinicians should counsel survivors on fertility potential in the context of their prior cancer treatments and on factors, including contraceptive efficacy and hormone-free contraception, that inform reproductive decision making in this population.

Effectiveness of ring pessaries versus vaginal hysterectomy for advanced pelvic organ prolapse. A cohort study

This study aimed to evaluate the efficacy of the ring pessary compared with surgery as a primary treatment for advanced pelvic organ prolapse (POP) in non-hysterectomized, postmenopausal women. Our starting hypothesis was that the pessary is as effective as and less risky than surgery. This study was a prospective observational study, which recruited 171 women with symptomatic advanced POP in a tertiary hospital for 30 months. They were treated according their preference with either surgery [77/171 (45.0%)] or vaginal ring pessary without support [94/171 (55.0%)]. The primary outcomes included the discontinuation of pessary use and the incidence of recurrent prolapse throughout the study. Secondary outcomes included complications categorized according to Clavien-Dindo classification. Descriptive statistics were used for demographic data. The mean and standard deviation were calculated for continuous variables, and continuity correction tests, Mann-Whitney U tests, and Fisher's exact tests were used for categorical variables. There was successful use of a pessary in 84.4% (76/90) of cases, and 89.6% (69/77) of patients did not have prolapse recurrence in the surgical group (>POP-Q 2). In the pessary group, the adverse event rate was 31.6%, and all were Clavien-Dindo grade I. Thirty patients [30/77 (39.0%)] had complications in the surgery group: 14.3% were Clavien-Dindo grade I (11/77), 10.4% were grade II (8/77), and 14.3% were grade III (11/77). The pessary is effective and has mild adverse events in non-hysterectomized, postmenopausal women with advanced POP.

Vaginal ring pessary use for pelvic organ prolapse: continuation rates and predictors of continued use.

The aim of the study was (1) to evaluate continuation rates of vaginal ring pessary for pelvic organ prolapse (POP), and (2) to identify predictors for continued pessary use. This retrospective chart review study was conducted in a tertiary center. Women who had a ring with support pessary successfully fitted between January 2009 and December 2013 and had completed up to 3 years of follow-up care were included in the analysis. Demographic and obstetric data, body weight, pelvic organ prolapse stage, and associated symptoms were evaluated. All the women were followed until February 28, 2017, unless surgery to correct POP surgery was required, pessary use was discontinued, or the women died. A total of 289 women with symptomatic POP (stages II, III, and IV) were evaluated. The median age was 71 years (range 34-83 y), and the median parity was 3 (range 0-8). Among the women with a successful initial fitting, the failure rate was 5.88% (17/289) at 6 months with most of these women choosing to have surgical intervention. This analysis indicates that the probability of the successful continuation of pessary use after 1, 2, 3, 4, and 5 years was 83.0%, 78.2%, 71.3%, 65.3%, and 61.7%, respectively, reported using a Kaplan-Meier plot. The main cause for discontinuation of pessary use before 3 years was the election for surgical intervention. With regard to predictors for continued pessary use, self-care was the only factor that influenced compliance rates after treatment of 3 years. A ring with support pessary can be used successfully to alleviate symptoms of advanced stage prolapse for 3 years or longer. In addition, proper self-management was found to be a strong predictor for prolonged pessary use.

Factors Associated with Successful Pessary Fitting for Pelvic Organ Prolapse

Symptomatic pelvic organ prolapse (POP) is typically managed with a vaginal pessary or pelvic reconstructive surgery; however, many women are not good

Phantoms in the Classroom: Midwifery Training in Enlightenment Europe

Phantoms in the Classroom: Midwifery Training in Enlightenment Europe