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European Journal of Obstetrics,... Jun 2021To determine the role of progesterone, pessary and cervical cerclage in reducing the risk of (preterm birth) PTB in twin pregnancies and compare these interventions... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To determine the role of progesterone, pessary and cervical cerclage in reducing the risk of (preterm birth) PTB in twin pregnancies and compare these interventions using pairwise and network meta-analysis.
STUDY DESIGN
Medline, Embase, CINAHL and Cochrane databases were explored. The inclusion criteria were studies in which twin pregnancies were randomized to an intervention for the prevention of PTB (any type of progesterone, cervical cerclage, cervical pessary, or any combination of these) or to a control group (e.g. placebo or treatment as usual). Interventions of interest were either progesterone [vaginal or oral natural progesterone or intramuscular 17a-hydroxyprogesterone caproate (17-OHPC)], cerclage (McDonald or Shirodkar), or cervical pessary. The primary outcome was PTB < 34 weeks of gestation. Both primary and secondary outcomes were explored in an unselected population of twin pregnancies and in women at higher risk of PTB (defined as those with cervical length <25 mm). Random-effect head-to-head and a multiple-treatment meta-analyses were used to analyze the data and results expressed as risk ratios.
RESULTS
26 studies were included in the meta-analysis. When considering an unselected population of twin pregnancies, vaginal progesterone, intra-muscular17-OHPC or pessary did not reduce the risk of PTB < 34 weeks of gestation (all p > 0.05). When stratifying the analysis for spontaneous PTB, neither pessary, vaginal or intramuscular 17-OHPC were associated with a significant reduction in the risk of PTB compared to controls (all p > 0.05), while there was no study on cerclage which explored this outcome in an unselected population of twin pregnancies. When considering twin pregnancies with short cervical length (≤25 mm), there was no contribution of either pessary, vaginal progesterone, intra-muscular 17-OHPC or cerclage in reducing the risk of overall PTB < 34 weeks of gestation.
CONCLUSIONS
Cervical pessary, progesterone and cerclage do not show a significant effect in reducing the rate of PTB or perinatal morbidity in twins, either when these interventions are applied to an unselected population of twins or in pregnancies with a short cervix.
Topics: Cerclage, Cervical; Female; Humans; Infant, Newborn; Network Meta-Analysis; Pessaries; Pregnancy; Pregnancy, Twin; Premature Birth; Progesterone
PubMed: 33946019
DOI: 10.1016/j.ejogrb.2021.04.023 -
BMJ (Clinical Research Ed.) Feb 2022To compare the efficacy of bed rest, cervical cerclage (McDonald, Shirodkar, or unspecified type of cerclage), cervical pessary, fish oils or omega fatty acids,... (Comparative Study)
Comparative Study
OBJECTIVES
To compare the efficacy of bed rest, cervical cerclage (McDonald, Shirodkar, or unspecified type of cerclage), cervical pessary, fish oils or omega fatty acids, nutritional supplements (zinc), progesterone (intramuscular, oral, or vaginal), prophylactic antibiotics, prophylactic tocolytics, combinations of interventions, placebo or no treatment (control) to prevent spontaneous preterm birth in women with a singleton pregnancy and a history of spontaneous preterm birth or short cervical length.
DESIGN
Systematic review with bayesian network meta-analysis.
DATA SOURCES
The Cochrane Pregnancy and Childbirth Group's Database of Trials, the Cochrane Central Register of Controlled Trials, Medline, Embase, CINAHL, relevant journals, conference proceedings, and registries of ongoing trials.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised controlled trials of pregnant women who are at high risk of spontaneous preterm birth because of a history of spontaneous preterm birth or short cervical length. No language or date restrictions were applied.
OUTCOMES
Seven maternal outcomes and 11 fetal outcomes were analysed in line with published core outcomes for preterm birth research. Relative treatment effects (odds ratios and 95% credible intervals) and certainty of evidence are presented for outcomes of preterm birth <34 weeks and perinatal death.
RESULTS
Sixty one trials (17 273 pregnant women) contributed data for the analysis of at least one outcome. For preterm birth <34 weeks (40 trials, 13 310 pregnant women) and with placebo or no treatment as the comparator, vaginal progesterone was associated with fewer women with preterm birth <34 weeks (odds ratio 0.50, 95% credible interval 0.34 to 0.70, high certainty of evidence). Shirodkar cerclage showed the largest effect size (0.06, 0.00 to 0.84), but the certainty of evidence was low. 17OHPC (17α-hydroxyprogesterone caproate; 0.68, 0.43 to 1.02, moderate certainty), vaginal pessary (0.65, 0.39 to 1.08, moderate certainty), and fish oil or omega 3 (0.30, 0.06 to 1.23, moderate certainty) might also reduce preterm birth <34 weeks compared with placebo or no treatment. For the fetal outcome of perinatal death (30 trials, 12 119 pregnant women) and with placebo or no treatment as the comparator, vaginal progesterone was the only treatment that showed clear evidence of benefit for this outcome (0.66, 0.44 to 0.97, moderate certainty). 17OHPC (0.78, 0.50 to 1.21, moderate certainty), McDonald cerclage (0.59, 0.33 to 1.03, moderate certainty), and unspecified cerclage (0.77, 0.53 to 1.11, moderate certainty) might reduce perinatal death rates, but credible intervals could not exclude the possibility of harm. Only progesterone treatments are associated with reduction in neonatal respiratory distress syndrome, neonatal sepsis, necrotising enterocolitis, and admission to neonatal intensive care unit compared with controls.
CONCLUSION
Vaginal progesterone should be considered the preventative treatment of choice for women with singleton pregnancy identified to be at risk of spontaneous preterm birth because of a history of spontaneous preterm birth or short cervical length. Future randomised controlled trials should use vaginal progesterone as a comparator to identify better treatments or combination treatments.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42020169006.
Topics: Administration, Intravaginal; Bayes Theorem; Female; Humans; Network Meta-Analysis; Pregnancy; Premature Birth; Progesterone; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35168930
DOI: 10.1136/bmj-2021-064547 -
The Cochrane Database of Systematic... Sep 2022Urinary incontinence (UI) is the involuntary loss of urine and can be caused by several different conditions. The common types of UI are stress (SUI), urgency (UUI) and... (Review)
Review
BACKGROUND
Urinary incontinence (UI) is the involuntary loss of urine and can be caused by several different conditions. The common types of UI are stress (SUI), urgency (UUI) and mixed (MUI). A wide range of interventions can be delivered to reduce the symptoms of UI in women. Conservative interventions are generally recommended as the first line of treatment.
OBJECTIVES
To summarise Cochrane Reviews that assessed the effects of conservative interventions for treating UI in women.
METHODS
We searched the Cochrane Library to January 2021 (CDSR; 2021, Issue 1) and included any Cochrane Review that included studies with women aged 18 years or older with a clinical diagnosis of SUI, UUI or MUI, and investigating a conservative intervention aimed at improving or curing UI. We included reviews that compared a conservative intervention with 'control' (which included placebo, no treatment or usual care), another conservative intervention or another active, but non-conservative, intervention. A stakeholder group informed the selection and synthesis of evidence. Two overview authors independently applied the inclusion criteria, extracted data and judged review quality, resolving disagreements through discussion. Primary outcomes of interest were patient-reported cure or improvement and condition-specific quality of life. We judged the risk of bias in included reviews using the ROBIS tool. We judged the certainty of evidence within the reviews based on the GRADE approach. Evidence relating to SUI, UUI or all types of UI combined (AUI) were synthesised separately. The AUI group included evidence relating to participants with MUI, as well as from studies that combined women with different diagnoses (i.e. SUI, UUI and MUI) and studies in which the type of UI was unclear.
MAIN RESULTS
We included 29 relevant Cochrane Reviews. Seven focused on physical therapies; five on education, behavioural and lifestyle advice; one on mechanical devices; one on acupuncture and one on yoga. Fourteen focused on non-conservative interventions but had a comparison with a conservative intervention. No reviews synthesised evidence relating to psychological therapies. There were 112 unique trials (including 8975 women) that had primary outcome data included in at least one analysis. Stress urinary incontinence (14 reviews) Conservative intervention versus control: there was moderate or high certainty evidence that pelvic floor muscle training (PFMT), PFMT plus biofeedback and cones were more beneficial than control for curing or improving UI. PFMT and intravaginal devices improved quality of life compared to control. One conservative intervention versus another conservative intervention: for cure and improvement of UI, there was moderate or high certainty evidence that: continence pessary plus PFMT was more beneficial than continence pessary alone; PFMT plus educational intervention was more beneficial than cones; more-intensive PFMT was more beneficial than less-intensive PFMT; and PFMT plus an adherence strategy was more beneficial than PFMT alone. There was no moderate or high certainty evidence for quality of life. Urgency urinary incontinence (five reviews) Conservative intervention versus control: there was moderate to high-certainty evidence demonstrating that PFMT plus feedback, PFMT plus biofeedback, electrical stimulation and bladder training were more beneficial than control for curing or improving UI. Women using electrical stimulation plus PFMT had higher quality of life than women in the control group. One conservative intervention versus another conservative intervention: for cure or improvement, there was moderate certainty evidence that electrical stimulation was more effective than laseropuncture. There was high or moderate certainty evidence that PFMT resulted in higher quality of life than electrical stimulation and electrical stimulation plus PFMT resulted in better cure or improvement and higher quality of life than PFMT alone. All types of urinary incontinence (13 reviews) Conservative intervention versus control: there was moderate to high certainty evidence of better cure or improvement with PFMT, electrical stimulation, weight loss and cones compared to control. There was moderate certainty evidence of improved quality of life with PFMT compared to control. One conservative intervention versus another conservative intervention: there was moderate or high certainty evidence of better cure or improvement for PFMT with bladder training than bladder training alone. Likewise, PFMT with more individual health professional supervision was more effective than less contact/supervision and more-intensive PFMT was more beneficial than less-intensive PFMT. There was moderate certainty evidence that PFMT plus bladder training resulted in higher quality of life than bladder training alone.
AUTHORS' CONCLUSIONS
There is high certainty that PFMT is more beneficial than control for all types of UI for outcomes of cure or improvement and quality of life. We are moderately certain that, if PFMT is more intense, more frequent, with individual supervision, with/without combined with behavioural interventions with/without an adherence strategy, effectiveness is improved. We are highly certain that, for cure or improvement, cones are more beneficial than control (but not PFMT) for women with SUI, electrical stimulation is beneficial for women with UUI, and weight loss results in more cure and improvement than control for women with AUI. Most evidence within the included Cochrane Reviews is of low certainty. It is important that future new and updated Cochrane Reviews develop questions that are more clinically useful, avoid multiple overlapping reviews and consult women with UI to further identify outcomes of importance.
Topics: Exercise Therapy; Female; Humans; Pelvic Floor; Quality of Life; Systematic Reviews as Topic; Urinary Incontinence; Weight Loss
PubMed: 36053030
DOI: 10.1002/14651858.CD012337.pub2 -
The Cochrane Database of Systematic... Aug 2016Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring). This is an update of a Chochrane systematic review; the original version was first published in October 2006.
OBJECTIVES
The objective of this review was to compare the efficacy and safety of intra-vaginal oestrogenic preparations in relieving the symptoms of vaginal atrophy in postmenopausal women.
SEARCH METHODS
We searched the following databases and trials registers to April 2016: Cochrane Gynaecology and Fertility Group Register of trials, The Cochrane Central Register of Controlled Trials (CENTRAL; 2016 issue 4), MEDLINE, Embase, PsycINFO, DARE, the Web of Knowledge, OpenGrey, LILACS, PubMed and reference lists of articles. We also contacted experts and researchers in the field.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for at least 12 weeks for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial eligibility and risk of bias and extracted the data. The primary review outcomes were improvement in symptoms (participant-assessed), and the adverse event endometrial thickness. Secondary outcomes were improvement in symptoms (clinician-assessed), other adverse events (breast disorders e.g. breast pain, enlargement or engorgement, total adverse events, excluding breast disorders) and adherence to treatment. We combined data to calculate pooled risk ratios (RRs) (dichotomous outcomes) and mean differences (MDs) (continuous outcomes) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I(2) statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.
MAIN RESULTS
We included 30 RCTs (6235 women) comparing different intra-vaginal oestrogenic preparations with each other and with placebo. The evidence was low to moderate quality; limitations were poor reporting of study methods and serious imprecision (effect estimates with wide confidence intervals)1. Oestrogen ring versus other regimensOther regimens included oestrogen cream, oestrogen tablets and placebo. There was no evidence of a difference in improvement in symptoms (participant assessment) either between oestrogen ring and oestrogen cream (odds ratio (OR) 1.33, 95% CI 0.80 to 2.19, two RCTs, n = 341, I(2) = 0%, low-quality evidence) or between oestrogen ring and oestrogen tablets (OR 0.78, 95% CI 0.53 to 1.15, three RCTs, n = 567, I(2) = 0%, low-quality evidence). However, a higher proportion of women reported improvement in symptoms following treatment with oestrogen ring compared with placebo (OR 12.67, 95% CI 3.23 to 49.66, one RCT, n = 67). With respect to endometrial thickness, a higher proportion of women who received oestrogen cream showed evidence of increase in endometrial thickness compared to those who were treated with oestrogen ring (OR 0.36, 95% CI 0.14 to 0.94, two RCTs, n = 273; I(2) = 0%, low-quality evidence). This may have been due to the higher doses of cream used. 2. Oestrogen tablets versus other regimensOther regimens in this comparison included oestrogen cream, and placebo. There was no evidence of a difference in the proportions of women who reported improvement in symptoms between oestrogen tablets and oestrogen cream (OR 1.06, 95% CI 0.55 to 2.01, two RCTs, n = 208, I(2) = 0% low-quality evidence). A higher proportion of women who were treated with oestrogen tablets reported improvement in symptoms compared to those who received placebo using a fixed-effect model (OR 12.47, 95% CI 9.81 to 15.84, two RCTs, n = 1638, I(2) = 83%, low-quality evidence); however, using a random-effect model did not demonstrate any evidence of a difference in the proportions of women who reported improvement between the two treatment groups (OR 5.80, 95% CI 0.88 to 38.29). There was no evidence of a difference in the proportions of women with increase in endometrial thickness between oestrogen tablets and oestrogen cream (OR 0.31, 95% CI 0.06 to 1.60, two RCTs, n = 151, I(2) = 0%, low-quality evidence).3. Oestrogen cream versus other regimensOther regimens identified in this comparison included isoflavone gel and placebo. There was no evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and isoflavone gel (OR 2.08, 95% CI 0.08 to 53.76, one RCT, n = 50, low-quality evidence). However, there was evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and placebo with more women who received oestrogen cream reporting improvement in symptoms compared to those who were treated with placebo (OR 4.10, 95% CI 1.88 to 8.93, two RCTs, n = 198, I(2) = 50%, low-quality evidence). None of the included studies in this comparison reported data on endometrial thickness.
AUTHORS' CONCLUSIONS
There was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other. However, there was low-quality evidence that intra-vaginal oestrogenic preparations improve the symptoms of vaginal atrophy in postmenopausal women when compared to placebo. There was low-quality evidence that oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring; this may have been due to the higher doses of cream used. However there was no evidence of a difference in the overall body of evidence in adverse events between the various oestrogenic preparations compared with each other or with placebo.
Topics: Administration, Intravaginal; Aged; Atrophy; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Isoflavones; Middle Aged; Postmenopause; Randomized Controlled Trials as Topic; Tablets; Vagina; Vaginal Creams, Foams, and Jellies; Vaginitis
PubMed: 27577677
DOI: 10.1002/14651858.CD001500.pub3 -
BJUI Compass Nov 2022Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review... (Review)
Review
INTRODUCTION
Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review aimed to consolidate all reported serious outcomes from pessaries usage to better identify and counsel patients who might be at higher risk of developing these adverse events.
METHODS
We performed a systematic literature review using search terms such as 'prolapse', 'stress urinary incontinence' and 'pessary or pessaries or pessarium' on PubMed, Embase and CINAHL. A total of 36 articles were identified. Patient-level data were extracted from case reports to further describe complications on an individual level.
RESULTS
Overall median age of the patients was 82 years (range 62-98). The most frequent complications were vesicovaginal fistula (25%, = 9/36), rectovaginal fistula (19%, = 7/36), vaginal impaction (11%, = 4/36) and vaginal evisceration of small bowel through vaginal vault (8%, = 3/36). In the vesicovaginal fistula cohort, none of the patients had a history of radiation, and two had histories of total abdominal hysterectomy (22%). In the rectovaginal fistula cohort, one patient had a history of pelvic radiation for rectal squamous cell carcinoma, and another had a history of chronic steroid use for rheumatoid arthritis. No other risk factors were reported in the other groups. Ring and Gellhorn were the most represented pessary types among the studies, 16 (44%) and 12 (33%), respectively. No complications were reported with surgical and non-surgical treatment of the complications.
CONCLUSION
Pessaries are a reasonable and durable treatment for POP with exceedingly rare reports of severe adverse complications. The ideal candidate for pessary should have a good self-care index. Studies to determine causative factors of the more serious adverse events are needed; however, this may be difficult given the long follow-up that is required.
PubMed: 36267197
DOI: 10.1002/bco2.174 -
Posterior compartment prolapse and perineal descent: systematic review of available support devices.International Urogynecology Journal Nov 2023The aim of our study is to systematically review the literature about available devices facilitating perineal support during defecation in patients with obstructive... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of our study is to systematically review the literature about available devices facilitating perineal support during defecation in patients with obstructive defecation syndrome (ODS) and posterior pelvic organ prolapse (POP).
METHODS
We searched for the terms "defecat/ion or ODS" and" pessar/ies or device/aid/tool/perineal/perianal/prolapse and support" in MEDLINE, PubMed and Web of Science. Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. A two-stage inclusion was performed, selecting first on title and abstract and secondly the full text. For variables with sufficient data, a meta-analysis was performed using a random-effects model. Other variables were descriptively reported.
RESULTS
Ten studies out of 1332 were included for systematic review. The devices could be categorized into three groups: pessaries (n = 8), vaginal stent (n = 1) and external support device (n = 1). Methodology and data reporting is heterogeneous. Meta-analysis could be performed for the Colorectal-Anal Distress Inventory (CRADI-8) and Impact Questionnaire (CRAI-Q-7) in three pessary studies which showed a significant mean change. Significant improvement of stool evacuation was seen in two other pessary studies. The vaginal stent significantly decreases ODS. Subjective perception of constipation improved significantly using the posterior perineal support device.
CONCLUSION
All reviewed devices seem to improve ODS in patients with POP. There are no data on their efficacy with regard to perineal descent-associated ODS. There is a lack of comparative studies between devices. Studies are difficult to compare due to different inclusion criteria and evaluation tools.
Topics: Female; Humans; Pelvic Organ Prolapse; Constipation; Vagina; Anal Canal; Perineum; Pessaries
PubMed: 37074368
DOI: 10.1007/s00192-023-05508-2 -
The Cochrane Database of Systematic... Nov 2020Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an...
BACKGROUND
Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse. This is an update of a Cochrane Review first published in 2003 and last published in 2013.
OBJECTIVES
To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.
MAIN RESULTS
We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms. The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.
Topics: Bias; Female; Humans; Muscle Strength; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic; Rectal Prolapse; Urethral Diseases; Urinary Bladder Diseases; Uterine Prolapse
PubMed: 33207004
DOI: 10.1002/14651858.CD004010.pub4 -
Frontiers in Medicine 2023Preterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on... (Review)
Review
BACKGROUND
Preterm birth is the leading cause of childhood mortality and morbidity. We aimed to provide a comprehensive systematic review on randomized controlled trials (RCTs) on progesterone, cerclage, pessary, and acetylsalicylic acid (ASA) to prevent preterm birth in asymptomatic women with singleton pregnancies defined as risk of preterm birth and multifetal pregnancies.
METHODS
Six databases (including PubMed, Embase, Medline, the Cochrane Library) were searched up to February 2022. RCTs published in English or Scandinavian languages were included through a consensus process. Abstracts and duplicates were excluded. The trials were critically appraised by pairs of reviewers. The Cochrane risk-of-bias tool was used for risk of bias assessment. Predefined outcomes including preterm birth, perinatal/neonatal/maternal mortality and morbidity, were pooled in meta-analyses using RevMan 5.4, stratified for high and low risk of bias trials. The certainty of evidence was assessed using the GRADE approach. The systematic review followed the PRISMA guideline.
RESULTS
The search identified 2,309 articles, of which 87 were included in the assessment: 71 original RCTs and 16 secondary publications with 23,886 women and 32,893 offspring. Conclusions were based solely on trials with low risk of bias ( = 50).Singleton pregnancies: Progesterone compared with placebo, reduced the risk of preterm birth <37 gestational weeks: 26.8% vs. 30.2% (Risk Ratio [RR] 0.82 [95% Confidence Interval [CI] 0.71 to 0.95]) (high certainty of evidence, 14 trials) thereby reducing neonatal mortality and respiratory distress syndrome. Cerclage probably reduced the risk of preterm birth <37 gestational weeks: 29.0% vs. 37.6% (RR 0.78 [95% CI 0.69 to 0.88]) (moderate certainty of evidence, four open trials). In addition, perinatal mortality may be reduced by cerclage. Pessary did not demonstrate any overall effect. ASA did not affect any outcome, but evidence was based on one underpowered study.Multifetal pregnancies: The effect of progesterone, cerclage, or pessary was minimal, if any. No study supported improved long-term outcome of the children.
CONCLUSION
Progesterone and probably also cerclage have a protective effect against preterm birth in asymptomatic women with a singleton pregnancy at risk of preterm birth. Further trials of ASA are needed. Prevention of preterm birth requires screening programs to identify women at risk of preterm birth.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/], identifier [CRD42021234946].
PubMed: 36936217
DOI: 10.3389/fmed.2023.1111315 -
International Urogynecology Journal Aug 2015Pelvic organ prolapse (POP) in pregnancy is a rare condition with decreasing incidence and improved management and outcome world-wide recently. Systematic review of the... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Pelvic organ prolapse (POP) in pregnancy is a rare condition with decreasing incidence and improved management and outcome world-wide recently. Systematic review of the literature for cases of POP in pregnancy published since 1990 was carried out to identify common factors in presentation, management and outcomes. One case from our own practice was added to the analysis.
METHODS
An extensive search of the Pubmed/Medline, Scopus and Google Scholar databases was performed to identify all cases of POP in pregnancy since 1990. Published case reports of POP in pregnancy were reviewed and summarized in tables to find similarities in history, course, management and outcome of the pregnancies.
RESULTS
Of the 43 cases and one case series, 41 case studies were eligible for analysis. Two types of POP in pregnancy were identified: preexisting is less common (14 vs 27 cases), often resolves during pregnancy (5 out of 14) and always recurs after delivery (14 out of 14); acute onset of POP in pregnancy rarely resolves in pregnancy (2 out of 27), but often resolves after delivery (18 out of 27). Most patients were managed with bed rest (20 out of 41), pessary (15 out of 41), manual reduction (6 out of 41) and local treatment (6 out of 41). The most common complications reported include preterm labour (14 out of 41), cervical ulcerations (9 out of 41), infection (3 out of 41) and obstructed labour (4 out of 41). About a half of the women delivered vaginally (22 out of 41), caesarean section due to prolapse was required in 15 cases.
CONCLUSIONS
Two distinct entities were identified based on similarities regarding onset, course and outcome of POP in pregnancy. Concise recommendations for practice were derived from the analysis of case studies published since 1990.
Topics: Bed Rest; Cesarean Section; Dystocia; Female; Humans; Obstetric Labor, Premature; Pelvic Organ Prolapse; Pessaries; Pregnancy; Pregnancy Complications; Pregnancy Complications, Infectious
PubMed: 25600351
DOI: 10.1007/s00192-014-2595-3 -
Archives of Gynecology and Obstetrics Jun 2024There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and meta-analysis is to assess the adherence to pessary treatment among women who engage in self-management of their pessary.
METHODS
We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected seven publications for inclusion in the analysis.
RESULTS
Pooled continuation rate of self-cared vaginal pessary was the 76% (95%CI: 66-85%) with a I-test of 93.3% (p < 0.001). Pooled conversion to POP surgery was the 12% (95%CI: 1-23%) with a I-test of 96% (p < 0.001). Continuation rate was not statistically different between women who were treated by self-care and non-self-care management of vaginal pessary (RR 1.11, 95%CI 0.96-1.27; p = 0.15), with a related I-test of 37% (p = 0.21).
CONCLUSION
Self-care vaginal pessary management presented a high continuation rate in women affected by pelvic organ prolapse at a long follow-up. The rate of conversion to surgical management of POP was low. No significant difference in continuation rate were highlighted between women who adopted the self-care or the clinical-based management of pessary.
Topics: Humans; Pelvic Organ Prolapse; Pessaries; Female; Self Care; Patient Compliance; Treatment Outcome
PubMed: 38634900
DOI: 10.1007/s00404-024-07506-1