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JAMA Dec 2022Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for... (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.
OBJECTIVE
To investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.
DESIGN, SETTING, AND PARTICIPANTS
The PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022.
INTERVENTIONS
Two hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.
MAIN OUTCOMES AND MEASURES
The primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured.
RESULTS
Among 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, -6.1% [1-sided 95% CI, -12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, -13.1% [1-sided 95% CI, -23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery.
CONCLUSIONS AND RELEVANCE
Among patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery.
TRIAL REGISTRATION
Netherlands Trial Register Identifier: NTR4883.
Topics: Female; Humans; Middle Aged; Netherlands; Patient Reported Outcome Measures; Pelvic Organ Prolapse; Pessaries; Quality of Life; Treatment Outcome; Aged; Gynecologic Surgical Procedures
PubMed: 36538310
DOI: 10.1001/jama.2022.22385 -
The Cochrane Database of Systematic... Dec 2022Preterm birth (PTB), defined as birth prior to 37 weeks of gestation, occurs in ten percent of all pregnancies. PTB is responsible for more than half of neonatal and... (Review)
Review
BACKGROUND
Preterm birth (PTB), defined as birth prior to 37 weeks of gestation, occurs in ten percent of all pregnancies. PTB is responsible for more than half of neonatal and infant mortalities and morbidities. Because cervical insufficiency is a common cause of PTB, one possible preventive strategy involves insertion of a cervical pessary to support the cervix. Several published studies have compared the use of pessary with different management options and obtained questionable results. This highlights the need for an up-to-date systematic review of the evidence.
OBJECTIVES
To evaluate the benefits and harms of cervical pessary for preventing preterm birth in women with singleton pregnancies and risk factors for cervical insufficiency compared to no treatment, vaginal progesterone, cervical cerclage or bedrest.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform to 22 September 2021. We also searched the reference lists of included studies for additional records.
SELECTION CRITERIA
We included published and unpublished randomised controlled trials (RCTs) comparing cervical pessary with no treatment, vaginal progesterone, cervical cerclage or bedrest for preventing PTB. We excluded quasi-randomised trials. Our primary outcome was delivery before 34 weeks' gestation. Our secondary outcomes were 1. delivery before 37 weeks' gestation, 2. maternal mortality, 3. maternal infection or inflammation, 4. preterm prelabour rupture of membranes, 5. harm to woman from the intervention, 6. maternal medications, 7. discontinuation of the intervention, 8. maternal satisfaction, 9. neonatal/paediatric care unit admission, 10. fetal/infant mortality, 11. neonatal sepsis, 12. gestational age at birth, 13. harm to offspring from the intervention 14. birthweight, 15. early neurodevelopmental morbidity, 15. late neurodevelopmental morbidity, 16. gastrointestinal morbidity and 17. respiratory morbidity.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for eligibility and risk of bias, evaluated trustworthiness based on criteria developed by the Cochrane Pregnancy and Childbirth Review Group, extracted data, checked for accuracy and assessed certainty of evidence using the GRADE approach.
MAIN RESULTS
We included eight RCTs (2983 participants). We included five RCTs (1830 women) in the comparison cervical pessary versus no treatment, three RCTs (1126 pregnant women) in the comparison cervical pessary versus vaginal progesterone, and one study (13 participants) in the comparison cervical pessary versus cervical cerclage. Overall, the certainty of evidence was low to moderate due to inconsistency (statistical heterogeneity), imprecision (few events and wide 95% confidence intervals (CIs) consistent with possible benefit and harm), and risk of performance and detection bias. Cervical pessary versus no treatment Cervical pessary compared with no treatment may reduce the risk of delivery before 34 weeks (risk ratio (RR) 0.72, 95% CI 0.33 to 1.55; 5 studies, 1830 women; low-certainty evidence) or before 37 weeks (RR 0.68, 95% CI 0.44 to 1.05; 5 studies, 1830 women; low-certainty evidence). However, these results should be viewed with caution because the 95% CIs cross the line of no effect. Cervical pessary compared with no treatment probably has little or no effect on the risk of maternal infection or inflammation (RR 1.04, 95% CI 0.87 to 1.26; 2 studies, 1032 women; moderate-certainty evidence). It is unclear if cervical pessary compared with no treatment has an effect on neonatal/paediatric care unit admission (RR 0.96, 95% CI 0.58 to 1.59; 3 studies, 1332 infants; low-certainty evidence) or fetal/neonatal mortality (RR 0.93, 95% CI 0.58 to 1.48; 5 studies, 1830 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus vaginal progesterone Cervical pessary may reduce the risk of delivery before 34 weeks (RR 0.72, 95% CI 0.52 to 1.02; 3 studies, 1126 women; moderate-certainty evidence) or before 37 weeks (RR 0.89, 95% CI 0.73 to 1.09; 3 studies, 1126 women; moderate-certainty evidence), but we are uncertain of the results because the 95% CI crosses the line of no effect. The intervention probably has little or no effect on maternal infection or inflammation (RR 0.95, 95% CI 0.81 to 1.12; 2 studies, 265 women; moderate-certainty evidence). It is unclear if cervical pessary compared with vaginal progesterone has an effect on the risk of neonatal/paediatric care unit admission (RR 0.98, 95% CI 0.49 to 1.98; low-certainty evidence) or fetal/neonatal mortality (RR 1.97, 95% CI 0.50 to 7.70; 2 studies; 265 infants; low-certainty evidence) because the 95% CIs are compatible with a wide range of effects that encompass both appreciable benefit and harm. Cervical pessary versus cervical cerclage Only one very small study of 13 pregnant women contributed data to this comparison; the results were unclear.
AUTHORS' CONCLUSIONS
In women with a singleton pregnancy, cervical pessary compared with no treatment or vaginal progesterone may reduce the risk of delivery before 34 weeks or 37 weeks, although these results should be viewed with caution due to uncertainty around the effect estimates. There is insufficient evidence with regard to the effect of cervical pessary compared with cervical cerclage on PTB. Due to low certainty-evidence in many of the prespecified outcomes and non-reporting of several other outcomes of interest for this review, there is a need for further robust RCTs that use standardised terminology for maternal and offspring outcomes. Future trials should take place in a range of settings to improve generalisability of the evidence. Further research should concentrate on comparisons of cervical pessary versus cervical cerclage and bed rest. Investigation of different phenotypes of PTB may be relevant.
Topics: Female; Pregnancy; Humans; Pessaries; Cervix Uteri; Progesterone; Premature Birth; Cerclage, Cervical
PubMed: 36453699
DOI: 10.1002/14651858.CD014508 -
Revista Brasileira de Ginecologia E... Jan 2019The gestational complication most associated with perinatal mortality and morbidity is spontaneous preterm birth with gestational age < 37 weeks. Therefore, it is... (Comparative Study)
Comparative Study Review
OBJECTIVE
The gestational complication most associated with perinatal mortality and morbidity is spontaneous preterm birth with gestational age < 37 weeks. Therefore, it is necessary to identify its risk factors and attempt its prevention. The benefits of the pessary in prematurity are under investigation. Our objective was to analyze the use of the pessary in the prevention of preterm births in published studies, and to compare its efficacy with other methods.
METHODS
Randomized clinical trials published between 2010 and 2018 were selected from electronic databases. Studies on multiple gestations were excluded.
RESULTS
Two studies were in favor of the pessary as a preventive method, one study was contrary to the method and another two showed no statistically significant difference. The meta-analysis showed no statistical difference with the use of a cervical pessary in the reduction of births < 37 (odds ratio [OR]: 0.63; confidence interval [95% CI]: 0.38-1.06) and < 34 weeks (OR: 0.74; 95% CI: 0.35-1.57) CONCLUSION: The pooled data available to date seems to show a lack of efficacy of the cervical pessary in the prevention of preterm birth, although the heterogeneity of the studies made comparisons more difficult.
Topics: Female; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30716786
DOI: 10.1055/s-0038-1676511 -
British Journal of Nursing (Mark Allen... May 2019Pelvic organ prolapse is a significant quality of life issue for many women. Prolapse can be managed effectively with a mechanical device called a pessary therefore many... (Review)
Review
UNLABELLED
Pelvic organ prolapse is a significant quality of life issue for many women. Prolapse can be managed effectively with a mechanical device called a pessary therefore many women choose this as a conservative treatment option. Despite the extent to which pessaries are used in the UK, there are no clear guidelines regarding the training required for pessary practitioners. This article reviews literature related to pessary practitioner training.
METHODS
13 publications were reviewed.
RESULTS
eight themes were identified, namely 'prevalence of pessary training', 'type of pessary training', confidence in pessary care provision', 'impact on pessary care', 'skills and knowledge required to be a pessary practitioner', 'barriers', 'speciality of pessary care providers', and 'ongoing support'.
CONCLUSION
at present practitioners report a lack of pessary training, which impacts on care. Effective training includes didactic learning of agreed knowledge requirements, practice of clinical skills and ongoing support.
Topics: Clinical Competence; Education, Nursing; Female; Humans; Nursing Education Research; Nursing Evaluation Research; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic
PubMed: 31070978
DOI: 10.12968/bjon.2019.28.9.S18 -
Urogynecology (Philadelphia, Pa.) Jun 2023
Topics: Humans; Pessaries; Pelvic Organ Prolapse
PubMed: 37093573
DOI: 10.1097/SPV.0000000000001360 -
Journal of Perinatal Medicine Jan 2017Preterm birth (PTB) represents a heavy burden in modern obstetrics as it is a major cause of perinatal morbidity and mortality. After the introduction of transvaginal... (Review)
Review
Preterm birth (PTB) represents a heavy burden in modern obstetrics as it is a major cause of perinatal morbidity and mortality. After the introduction of transvaginal sonography (TVS) screening, secondary prevention of PTB has been re-evaluated on the basis of pre-existing cervical length (CL) and meanwhile the cervical pessary has become an object of increasing interest. This device consists of a silicone cone acting mechanically, that can be easily placed or removed, but whose efficacy is still controversial. Therefore, this study aims to review the most recent evidence regarding its efficacy for prevention of PTB, together with the correct position, the evidence regarding the mechanism of action, the exclusion criteria for pessary placement and the reasons for precocious removal. Overall, it is well tolerated and there are no reports on severe associated side effects. Finally, we discuss published data regarding cervical pessary efficacy. Although results are still conflicting, it seems however to be an effective method for preventing PTB, both in singleton and multiple pregnancies, but further evidence is needed.
Topics: Contraindications; Female; Humans; Pessaries; Pregnancy; Pregnancy, Multiple; Premature Birth; Treatment Outcome
PubMed: 27171387
DOI: 10.1515/jpm-2016-0076 -
International Urogynecology Journal Jul 2022To clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up.
METHODS
Embase, 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 RESULTS
Twenty-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).
CONCLUSION
During 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.
Topics: Female; Humans; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Urinary Incontinence, Stress; Vagina
PubMed: 35037973
DOI: 10.1007/s00192-021-05015-2 -
The Journal of Maternal-fetal &... Jun 2018Preterm births occur frequently in multiple pregnancies with a short cervix. The cervical pessary is a potential intervention for prevention of preterm births. (Review)
Review
BACKGROUND
Preterm births occur frequently in multiple pregnancies with a short cervix. The cervical pessary is a potential intervention for prevention of preterm births.
OBJECTIVE
To assess the effectiveness of cervical pessary in the prevention of preterm births in multiple pregnancies with a short cervix (<25 mm).
SEARCH STRATEGY
Major databases from 2006 to 20th November 2016 were searched for relevant terms.
SELECTION CRITERIA
We included randomized controlled trials that assessed the effectiveness of cervical pessary on pregnancy outcomes in multiple pregnancies with a short cervix.
DATA COLLECTION AND ANALYSIS
Risk ratio was used as the summary measure with random effects model. We assessed heterogeneity between studies using the I index. Quality assessment was done based on Cochrane Handbook Method.
MAIN RESULTS
Pooled data showed no benefit of using cervical pessary in the prevention of preterm births, birth weights less than 1500 g, less than 2500 g, adverse neonatal events and fetal/neonatal deaths in twin pregnancies with a short cervix.
CONCLUSION
We are unable to show benefit of using cervical pessary in preventing preterm births in twin pregnancies with a short cervix. However, as cervical pessary is a reasonable intervention, there is a need for more randomized controlled trials in this area.
Topics: Female; Humans; Pessaries; Pregnancy; Pregnancy, Multiple; Premature Birth
PubMed: 28412851
DOI: 10.1080/14767058.2017.1319930 -
Urologic Nursing 2012Successful use of vaginal support pessaries requires provider and patient understanding of expected symptom-relief, potential complications, self-care options, and... (Review)
Review
Successful use of vaginal support pessaries requires provider and patient understanding of expected symptom-relief, potential complications, self-care options, and evaluation and treatment of pessary-related problems. This second article in a three-part series summarizes clinical recommendations and evidence related to pessary management.
Topics: Continuity of Patient Care; Education, Nursing, Continuing; Female; Humans; Pelvic Organ Prolapse; Pessaries; Specialties, Nursing; Vaginal Diseases
PubMed: 22860391
DOI: No ID Found -
Scientific Reports Nov 2022Pelvic organ prolapse affects up to 50% of parous women. Commonly used treatment options have unwelcome attributes; pessaries can cause erosion and estrogen creams need...
Pelvic organ prolapse affects up to 50% of parous women. Commonly used treatment options have unwelcome attributes; pessaries can cause erosion and estrogen creams need to be applied frequently, which is inconvenient and difficult to administer. This study involved the development of an estriol-releasing pessary utilising 3D printing molds. We incorporated varying amounts of estriol (1%, 10% and 15%) into the silicone pessary. We optimised the mechanical aspects of the pessary so it had a similar strength to commercially available pessaries. We investigated estriol release from the pessary over 3 months. We explored possible interactions between the drug and polymers via FTIR. The MED-4870 silicone ring with similar mechanical strength to pessaries currently used to treat pelvic organ prolapse. The medical pessaries present a sustained release in simulated vaginal fluid over 3 months. The pessary with 10% estriol delivered the optimal dose at 0.8 mg each week. Mechanical strength of this pessary showed no difference after emersion in simulated vaginal fluid for 3-month, supporting the long-term application. An estriol-loaded pessary was successfully developed to treat pelvic organ prolapse with sustained release of estriol over 3 months. This pessary provides promising potential to treat pelvic organ prolapse and vaginal atrophy.
Topics: Female; Humans; Pessaries; Delayed-Action Preparations; Pelvic Organ Prolapse; Estriol; Silicones
PubMed: 36414726
DOI: 10.1038/s41598-022-23791-9