-
BMJ Open May 2024To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.
OBJECTIVE
To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.
DESIGN
Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.
SETTING
21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.
PARTICIPANTS
1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.
INTERVENTIONS
Pessary therapy and surgery.
PRIMARY AND SECONDARY OUTCOME MEASURES
The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.
RESULTS
For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives.
CONCLUSIONS
Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.
TRIAL REGISTRATION NUMBER
NTR4883.
Topics: Humans; Pessaries; Female; Cost-Benefit Analysis; Pelvic Organ Prolapse; Middle Aged; Netherlands; Aged; Quality-Adjusted Life Years; Treatment Outcome; Quality of Life
PubMed: 38692718
DOI: 10.1136/bmjopen-2023-075016 -
Reproduction in Domestic Animals =... Oct 2023During the sheep breeding season, ovulatory follicles vary widely in age at pessary removal impacting both the timing of oestrus and pregnancy rates following artificial...
During the sheep breeding season, ovulatory follicles vary widely in age at pessary removal impacting both the timing of oestrus and pregnancy rates following artificial insemination (AI). Ovulatory follicles that emerge between days 7 to 9 of the pessary period are associated with higher fertility whilst those that emerge earlier or later are associated with lower fertility. In this study, two strategies to improve the success of AI by controlling the development of the ovulatory follicle were examined. In the first, ewes were treated with PGF2α at either -12 and/or +6 days (experiment 1) or -27 days (experiment 2) relative to pessary insertion to control the time of emergence of the ovulatory follicle. In the second, ewes were treated with eCG (400 IU per ewe) at either 0 h, -6 h or -12 h relative to pessary removal (experiment 3) to improve the development of young ovulatory follicles. PGF2α administered on day -27 increased the percentage of pregnant ewes by 17.8% and the number of foetuses per 100 ewes inseminated by 33.9%. PGF2α treatment at other times had either no effect or reduced fertility. During the breeding season, treatment with eCG at -12 h improved the synchrony of oestrus, reduced the size of the ovulatory follicle but did not improve pregnancy rate compared with other treatments. Treatment had no effect during the non-breeding season, supporting earlier findings that the quality of young ovulatory follicles differs during the year. In conclusion, PGF2α treatment 27 days before pessary insertion provides a new and cheap strategy to improve the success of fixed-time AI programs.
PubMed: 37573132
DOI: 10.1111/rda.14450 -
AJOG Global Reports May 2024The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester.... (Review)
Review
The effect of cervical pessary on increasing gestational age at delivery in twin pregnancies with asymptomatic short cervix: a systematic review and meta-analysis of randomized controlled trials.
OBJECTIVE
The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester. Studies are contradictory regarding the efficacy of a cervical pessary to decrease preterm birth in twin pregnancies and short cervical length. To conduct a systematic review and meta-analysis investigating the efficacy of cervical pessary in prolonging gestation, preventing preterm birth, and reducing adverse neonatal outcomes in twin pregnancies with an asymptomatic short cervix.
DATA SOURCES
PubMed, Scopus, Web of Science, and ClinicalTrials.org were searched for randomized controlled trials from inception to June 2023.
STUDY ELIGIBILITY CRITERIA
In this study, randomized controlled trials comparing the cervical pessary to expectant management in the pregnant population with twin gestations and asymptomatic short cervix were included.
METHODS
The Cochrane risk-of-bias-2 tool for randomized controlled trials was used for the evaluation of the risk of bias in included studies. A meta-analysis was performed by calculating risk ratio and mean difference with their 95% confidence interval using the random effects model or fixed effect model on the basis of heterogeneity and accounting for potential covariates among the included randomized controlled trials.
RESULTS
A total of 6 randomized controlled trials were included in the analysis. Cervical pessary did not significantly increase the gestational age at delivery in twin pregnancies with asymptomatic patients (mean difference, 0.36 weeks [-0.27 to 0.99]; =.270; I=72.0%). Moreover, the cervical pessary use did not result in a reduction of spontaneous or all-preterm birth before 37 weeks of gestation (risk ratio, 0.88 [0.77-1.00]; =.061; I=0.0%). There was no statistically significant difference in the composite neonatal adverse outcomes (risk ratio, 1.001 [0.86-1.16]; =.981; I=20.9%), including early respiratory morbidity, intraventricular hemorrhage, necrotizing enterocolitis, and confirmed sepsis.
CONCLUSION
The use of cervical pessary in twin pregnancies with asymptomatic short cervix does not seem to be effective in increasing the gestational age at delivery, preventing preterm birth, or reducing adverse neonatal outcomes. This indicates that alternative interventions should be sought for the management of this patient population.
PubMed: 38655568
DOI: 10.1016/j.xagr.2024.100347 -
International Urogynecology Journal Jul 2024Pessary self-management offers benefits to women with no increased risk of complications. However, many are unwilling to self-manage, preferring clinician-led care. This...
Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK.
INTRODUCTION AND HYPOTHESIS
Pessary self-management offers benefits to women with no increased risk of complications. However, many are unwilling to self-manage, preferring clinician-led care. This study is aimed at exploring factors associated with willingness to self-manage a pessary.
METHODS
Women attending pessary clinic at a UK hospital were asked to complete a questionnaire providing responses on pessary use, comorbidities, female genital self-image, self-management experience and willingness (or not) to learn self-management. Based upon statistical advice we aimed to recruit 90 women. Data were analysed using the non-parametric Kruskal-Wallis test and Chi-squared test. Free text data were analysed thematically.
RESULTS
A total of 89 women completed the questionnaire. Thirty-three women (38%) had previously been taught pessary self-management. Of the remaining women, 12 (21%) were willing to learn, 28 (50%) were not willing and 16 (29%) were unsure. There was no correlation between female genital self-image and willingness to self-manage a pessary. Younger women were more willing to learn self-management (p = < 0.001). Willing women were motivated by reduced follow-up visits. Self-managing women reported benefits including increased autonomy, cleanliness and giving their body "a break". Reasons discouraging women from self-managing were a lack of confidence; feeling physically unable; wanting clinician-led care; fear of problems or previous problems with their pessary.
CONCLUSIONS
Most women were either unsure about pessary self-management or unwilling to self-manage. Age was the only factor we found that had a significant relationship with willingness to self-manage a pessary. With robust self-management teaching, support and follow-up, it is likely that many of the barriers women report can be overcome.
PubMed: 38953998
DOI: 10.1007/s00192-024-05840-1 -
Urogynecology (Philadelphia, Pa.) Feb 2024There is currently a paucity of data describing the outcomes of women with pelvic organ prolapse (POP) and/or urinary incontinence (UI) who present with pessary-related...
IMPORTANCE
There is currently a paucity of data describing the outcomes of women with pelvic organ prolapse (POP) and/or urinary incontinence (UI) who present with pessary-related complications.
OBJECTIVE
This study aimed to describe outcomes in women with POP and UI managed with a pessary who present with pessary-related complications.
STUDY DESIGN
This was a retrospective cohort study of women with POP and/or UI who elected for management with a pessary from January 1, 2016, to December 31, 2020. Patients were included if they had used a pessary for at least 1 year and had a documented pessary-related complication. Complications were defined a priori, and patient charts were abstracted using International Classification of Diseases, Ninth and Tenth Revisions codes associated with pessary use.
RESULTS
Of 2,088 of women receiving pessary care, 444 (21%) experienced a complication. Of 154 of women, 34.6% experienced 2 pessary-related complications during the study period, whereas 12.6% (56) experienced 3, 4.5% (20) experienced 4, and 1.8% (8) experienced 5. One hundred fifty-two patients (34.2%) underwent surgery during the study period to manage their POP and/or UI. Patients who were older were less likely to have surgery (adjusted odds ratio, 0.70 [95% confidence interval, 0.20-0.90]; P = 0.002), and patients who had an indication of pessary use for both POP and UI were more likely to undergo surgery during the study period (adjusted odds ratio, 2.12 [95% confidence interval, 1.29-3.48]; P = 0.003).
CONCLUSIONS
Our results suggest that 1 in 5 patients has a documented complication associated with pessary use of greater than 1 year. Of these patients, one third will eventually undergo surgery for management of their POP and/or UI.
Topics: Humans; Female; Retrospective Studies; Pessaries; Pelvic Organ Prolapse; Data Collection; Urinary Incontinence
PubMed: 37556384
DOI: 10.1097/SPV.0000000000001402 -
American Journal of Obstetrics and... Nov 2023Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.
The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial.
BACKGROUND
Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.
OBJECTIVE
This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome.
STUDY DESIGN
In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned.
RESULTS
The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58-2.47; P=.63). No differences between groups was observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity.
CONCLUSION
In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.
PubMed: 38036166
DOI: 10.1016/j.ajog.2023.11.1245 -
International Journal of Gynaecology... May 2024Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. (Review)
Review
Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
BACKGROUND
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.
OBJECTIVES
Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure.
SEARCH STRATEGY AND SELECTION CRITERIA
Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.
DATA COLLECTION AND ANALYSIS
We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices.
MAIN RESULTS
Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls.
CONCLUSION
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Pessaries; Medical Device Legislation; Randomized Controlled Trials as Topic; Cervix Uteri; Pregnancy, Twin
PubMed: 37830250
DOI: 10.1002/ijgo.15169 -
Frontiers in Reproductive Health 2023Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be...
Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be inserted and removed from the vagina repeatedly over a woman's lifetime. In the United States (US), these products are considered to be medical devices and are regulated by the Center for Devices & Radiological Health (CDRH) of the Food and Drug Administration (FDA). As such, they are subject to both premarket and postmarket regulatory controls. Both tampons and pessaries have a long history of safe and effective use, and FDA applies a risk-based approach to both premarket entry as well as continued postmarket regulatory controls. Practicing clinicians are often the initial source of ideas for medical device improvements. This article is intended to help such clinicians to understand the regulatory challenges faced by development teams who seek to introduce these kinds of products to the US market. It explains FDA's risk-based classification of medical devices and the 510(k) premarket notification as the primary regulatory mechanism for market entry. It also highlights key FDA guidance documents and encourages early engagement with FDA when appropriate.
PubMed: 37795520
DOI: 10.3389/frph.2023.1224421 -
Annals of Medicine and Surgery (2012) Aug 2023Uterine prolapse (UP) is rare during pregnancy. It sometimes leads to serious complications such as abortion, preterm labor, and maternal death. The main risk factor for...
UNLABELLED
Uterine prolapse (UP) is rare during pregnancy. It sometimes leads to serious complications such as abortion, preterm labor, and maternal death. The main risk factor for UP is previous vaginal childbirth and is usually managed conservatively. However, surgery should be considered in cases of unavailability or failure of conservative approaches.
CASE PRESENTATION
A 34-year-old Gravid4Para3 pregnant woman in the 33rd week of gestation presented with refractory vaginal pain. She had a remarkable history of second-degree UP. Upon presentation, the anterior and posterior cervical lips were swollen, bluish, and protruding through the vagina. Considering the severe pain, the alarming examination findings, and the impossibility of pushing back the protruding mass, a total vaginal hysterectomy was performed. The postoperative pathological study revealed a massive hemorrhage with edematous changes in the vaginal cuff and cervical mucosa in addition to features of placenta accreta, placenta previa, and placenta abruption.
CONCLUSIONS
UP is a rare but potentially serious condition, especially if it is related to pregnancy. Moreover, managing UP could be challenging in low-income settings, where even simple conservative methods might be unavailable or financially unattainable.
PubMed: 37554873
DOI: 10.1097/MS9.0000000000001044 -
European Journal of Obstetrics,... Apr 2024Premature births are a health problem arising in triplet pregnancies, resulting in high levels of morbidity and mortality. The objective of this study is to evaluate the... (Observational Study)
Observational Study
OBJECTIVE
Premature births are a health problem arising in triplet pregnancies, resulting in high levels of morbidity and mortality. The objective of this study is to evaluate the utility of cervical pessaries in reducing prematurity (<34 weeks) in triplet pregnancies.
METHODS
This is a single-center, retrospective case-control study regarding triplet pregnancies with follow-up at the La Paz University Hospital between 2000 and 2023. Maternal characteristics, obstetric and perinatal outcomes, and the use of cervical pessaries were examined.
RESULTS
165 triplet pregnancies were analyzed: 87 (52.7 %) in the case group (premature triplet pregnancies) and 78 in the control group (non-premature triplet pregnancies). A cervical pessary was inserted in 15 (17.2 %) triplet pregnancies in the case group and in 12 (16.7 %) triplet pregnancies in the control group (p = 0.92; OR = 1.04 (0.46-2.35)). A pessary was later inserted in the non-premature group (p = 0.01). The risk of preterm labor and the use of tocolytics ± glucocorticoids were found to be significantly more frequent in the premature group, with p = 0.01; OR = 2.30 (1.21-4.36) and p < 0.01; OR = 2.36 (1.23-4.44), respectively. Protocol-based cesarean sections were more frequent in the non-premature group (p < 0.01), while cesarean sections due to maternal complications (p < 0.01) and premature membrane rupture (p < 0.01) were more frequent in the premature group.
CONCLUSION
The cervical pessary is not useful in preventing preterm births (< 34 weeks) in triplet pregnancies. It is likely that being pregnant with triplets is a powerful independent factor associated with prematurity, despite other pregnancy conditions. Women who are pregnant with triplets and at risk of preterm labor and those taking tocolytics ± glucocorticoids may benefit from pessary insertion.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Retrospective Studies; Pessaries; Pregnancy, Triplet; Tocolytic Agents; Case-Control Studies; Obstetric Labor, Premature; Cervix Uteri
PubMed: 38335584
DOI: 10.1016/j.ejogrb.2024.01.036