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Introduction and Hypothesis Vaginal pessaries are the mainstay of the non-surgical management of pelvic organ prolapse (POP). A flexible silicone irregular hexagonal (SIH) pessary was developed based on the results of a prior vaginal case study. We hypothesised that the SIH pessary would have a higher rate of retention and self-management than the polyvinyl chloride (PVC) pessary. Methods This was a prospective non-blinded, randomised controlled trial with institutional review board approval. Eligible participants were randomised and fitted with the assigned pessary. They were reviewed 1 week, 6 months and 1 year after the initial pessary fitting. Participants who returned for follow-up completed the study questionnaires. The primary outcome was success, defined as continued use of the allocated pessary at 6 months. Secondary outcomes included the ability to perform pessary self-care, treatment satisfaction and pessary-related complications. Statistical tests were performed with alpha or statistical significance defined as a p value of ≤ 0.05, two-tailed. Results A total of 104 participants were randomised, with 52 subjects in each arm. Primary outcome data were analysed using per protocol analysis. Continuing pessary usage at 6 months was 68.1% for the PVC pessary group and 65.1% for the SIH group, with no statistically significant differences between the two groups ( p  = 0.765). Subjects with SIH were more likely to perform pessary self-care. There were no significant differences in subjects’ satisfaction, quality-of-life scores or treatment complications between groups. Conclusions The pessary continuation rate between the SIH and the PVC pessary groups was similar at 6 months. Participants with an SIH pessary were more likely to self-manage.

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. 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, number NTR1858. Between Sept 21, 2009, and March 9, 2012, 813 women underwent randomisation, of whom 808 were analysed (401 in the pessary group; 407 in the control group). At least one child of 53 women (13%) in the pessary group had poor perinatal outcome, compared with 55 (14%) in the control group (relative risk 0·98, 95% CI 0·69–1·39). In unselected women with a multiple pregnancy, prophylactic use of a cervical pessary does not reduce poor perinatal outcome. The Netherlands Organisation for Health Research and Development.

Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.

Introduction and hypothesis Gellhorn and shelf pessaries can be effective management for women with pelvic organ prolapse (POP). This study aimed to investigate the opinion of IUGA members about shelf/Gellhorn pessary use, and in particular, how often to change them in patients with POP. There are no evidence-based guidelines available on this subject. Methods Members of the International Urogynaecology Association (IUGA) and the British Society of Urogynaecology (BSUG) were sent a single electronic mailing of semi-structured questionnaires containing closed and open questions and free text response boxes. The internet-based survey consisted of 13 questions. Free text responses were analysed using a thematic qualitative analysis. Results A total of 322 respondents from the IUGA membership participated in the survey. Most consider shelf/Gellhorn pessaries an effective first-line treatment for their patients with POP. Self care is usually acceptable with ring pessaries, but with shelf/Gellhorn, 35 % would like to change them every 3 months, 31 % every 6 months and the rest varied. The routine use of oestrogens along with shelf/Gellhorn pessaries is a common practice. The risk of urogenital fistulae is well documented, but overall clinicians felt that shelf/Gellhorn pessaries are a safe and effective treatment for POP. Conclusions This study highlights the wide variation in global practice of the management of shelf/Gellhorn pessaries for POP. In order to inform our practice, evidence-based guidelines are required. A randomised control trial may help to decide whether or not it is appropriate to change the shelf/Gellhorn pessaries at all.

ObjectivesTo clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up.MethodsEmbase, PubMed and Cochrane CENTRAL library were searched in May 2020. Inclusion criteria were: (1) pessary fitting attempted in women with symptomatic POP; (2) pessary fitting success among the study outcomes with a maximal follow-up of 3 months; (3) baseline parameters compared between successful and unsuccessful group. A meta-analysis was performed using the random effects model.Main resultsTwenty-four studies were included in the meta-analysis. Parameters associated with unsuccessful pessary fitting were: age (OR 0.70, 95% CI 0.56–0.86); BMI (OR 1.35, 95% CI 1.08–1.70); menopause (OR 0.65 95% CI 0.47–0.88); de novo stress urinary incontinence (OR 5.59, 95% CI 2.24–13.99); prior surgery, i.e. hysterectomy (OR 1.88, 95% CI 1.48–2.40), POP surgery (OR 2.13, 95% CI 1.34–3.38), pelvic surgery (OR 1.81, 05% CI 1.01–3.26) and incontinence surgery (OR 1.87, 95% CI 1.08–3.25); Colorectal-Anal Distress Inventory-8 scores (OR 1.92, 95% CI 1.22–3.02); solitary predominant posterior compartment POP (OR 1.59, 95% CI 1.08–2.35); total vaginal length (OR 0.56, 95% CI 0.32–0.97); wide introitus (OR 4.85, 95% CI 1.60–14.68); levator ani avulsion (OR 2.47, 95% CI 1.35–4.53) and hiatal area on maximum Valsalva (OR 1.89, 95% CI 1.27–2.80).ConclusionDuring counselling for pessary treatment a higher risk of failure due to the aforementioned parameters should be discussed and modifiable parameters should be addressed. More research is needed on the association between anatomical parameters and specific reasons for unsuccessful pessary fitting.

Background Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention. Methods The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura’s social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition. Results The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team. Conclusions The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management. Trial registration ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017

Introduction and hypothesisThe objective of this study was to compare the functional outcomes after pessary treatment and after prolapse surgery as primary treatments for pelvic organ prolapse (POP).MethodsThis was a prospective cohort study performed in a Dutch teaching hospital in women with symptomatic POP of stage II or higher requiring treatment. Patients were treated according to their preference with a pessary or prolapse surgery. The primary endpoint was disease-specific quality of life at 12 months follow-up according to the prolapse domain of the Urogenital Distress Inventory (UDI) questionnaire. Secondary outcomes included adverse events and additional interventions. To show a difference of ten points in the primary outcome, we needed to randomize 80 women (power 80%, α 0.05, taking 10% attrition into account).ResultsWe included 113 women (74 in the pessary group, 39 in the surgery group). After 12 months, the median prolapse domain score was 0 (10th to 90th percentile 0–33) in the pessary group and 0 (10th to 90th percentile 0–0) in the surgery group (p < 0.01). Differences in other domain scores were not statistically significant. In the pessary group, 28% (21/74) of the women had a surgical intervention versus 3% (1/39) reoperations in the surgery group (p = 0.01).ConclusionsIn women with POP of stage II or higher undergoing surgery, prolapse symptoms were less severe than in those who were treated with a pessary, but 72% of women who were treated with a pessary did not opt for surgery.Trial registration number: Dutch trial register NTR2856.

Background Vaginal pessary therapy is a well-known conservative treatment of pelvic organ prolapse (POP). According to several national guidelines, pessary therapy should be used as a first-line treatment for pelvic organ prolapse. A distinction is made between pessaries that can be worn permanently or require daily control. This therapy is primarily chosen by elderly patients who are not suitable for surgery or by patients not wishing to undergo surgical treatment. The aim of our study was to investigate what demographic, socioeconomic and functional health-related factors play a role in the choice of the pessary types, and to provide healthcare professionals with guidance on recommending a pessary type to patients based on these factors. Methods 115 female patients using vaginal pessaries for POP were included in our study (group I:73 pts used a daily control “cube” pessary (DCP), group II.:42 pts used a long-term wear ring pessary (LTP). Data collection was performed between March 2021 and March 2022 through a personally completed questionnaire or telephone interview. The following factors were investigated: patients’ age, fertility, education level, employment status, marital status, independence, hand function, vision, mobility, physical and sexual activity. Results A significant difference was found between the DCP and LTP groups in terms of average age (44.9 vs. 75.7 years p  < 0.0001), fertility (61.6 vs. 4.6% p  < 0.0001), employment status (retired: 18 vs. 100% p  < 0.0001), marital status (single: 8.3 vs. 44.1% p  < 0.0001) and educational level (highest: 81.9 vs. 25.6% p  < 0.0001). In terms of functional health-related factors, such as weakened hand function (1.4 vs. 34.9% p  < 0.0001), vision impairment (19.4 vs. 58.1% p  < 0.0001), reduced mobility (5.5 vs. 81.4% p  < 0.0001), sexual activity ratio (87.5 vs. 0% p  < 0.0001), and the level of physical activity (VAS: 9.5 vs. 6.1 p  < 0.01) also significant differences were registered between the DCP and LTP groups. Conclusions The choice of the type of vaginal pessary treatment for POP is influenced by many patient-side factors. Trial registration The study was conducted with the approval of the Regional Institutional Scientific and Research Ethics Committee of Semmelweis University (SE RKEB 97/2022).

Introduction and hypothesis Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion. Methods A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected. Results Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4–7) than for insertion (mean 2.66, median 2, IQR 2–4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions. Conclusions Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.

Introduction and hypothesisEvidence and recommendations for the use of intravaginal estrogen for prevention of bacterial vaginosis and pessary-related complications are limited and controversial. We hypothesized that adding intravaginal estrogen to pessary use would decrease the incidence of bacterial vaginosis and other pessary-related complications.MethodsA single-center, open-label, randomized, parallel study was conducted between April 2018 and August 2020. Participants were randomized to either receive intravaginal estriol 0.03 mg plus Lactobacillus acidophilus 100 million viable cell vaginal tablets or have no treatment. The Amsel criteria, normal flora index, visual analog scale, Thai version of the ICIQ-VS (International Consultation on Incontinence Questionnaire-Vaginal symptoms) questionnaire, vaginal abrasions and vaginal bleeding were evaluated at entry and at 2- and 14-week follow-up.ResultsSeventy-eight women were included and randomized to two groups (39 women per group). At 2-week follow-up, one participant in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (2.7% vs. 5.7%, p = 0.609). At 14-week follow-up, two participants in the intervention group and two participants in the control group were diagnosed with bacterial vaginosis (5.7% vs. 6.2%, p = 0.926). Normal flora index was significantly different at 2-week follow-up [8 (6.3) vs. 5 (6.0), p = 0.032]. There was no significant difference in the visual analog scale, Thai version of the ICIQ-VS, vaginal abrasions and vaginal bleeding between the 2- and 14-week follow-ups.ConclusionsThis study shows no benefit of intravaginal estrogen in reducing bacterial vaginosis, vaginal abrasions, vaginal bleeding and pain in postmenopausal women using a vaginal pessary for pelvic organ prolapse treatment.