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Female Pelvic Medicine & Reconstructive... Jun 2022Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Pessaries are an important conservative therapy for stress urinary incontinence (SUI), but few studies have comprehensively evaluated their utility.
OBJECTIVE
The objective of this study is to evaluate the existing evidence on the efficacy and safety of pessaries for the treatment of SUI.
STUDY DESIGN
We searched for the terms "stress urinary incontinence" and "pessar/y/ies/ium" in PubMed, Embase, and Cinhal on June 10, 2020. Studies that characterized subjective and/or objective data were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for SUI were excluded. Two reviewers independently screened and assessed data quality and risk of bias according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
Ten studies, including 376 patients, were included. In terms of subjective outcomes, 76% of 72 patients reported feeling continent after pessary treatment compared with 0% of 86 patients surveyed before pessary use (P < 0.0001). Both Urinary Distress Inventory and Incontinence Impact Questionnaire scores decreased significantly by 46.7% (n = 155 baseline, n = 139 follow-up; P < 0.0001) and 67.8% (n = 139 baseline, n = 107 follow-up; P < 0.0001), respectively. Significant objective measures associated with pessary use included increased urethral closure pressure (n = 122; g = 0.56; 95% confidence interval [CI], -0.66 to 1.77; P < 0.049) and decreased pad weight (n = 129 baseline; n = 118 follow-up; g = -0.89; 95% CI, -1.986 to 0.19; P = 0.009). Adverse events significantly decreased at greater than 6 months follow-up compared with less than 6 months follow-up, including pain (31.5%, n = 29/92 vs 14.3%, n = 5/35; P = 0.0513) and discomfort (50%, n = 46/92 vs 29.3%, n = 12/41; P = 0.0268).
CONCLUSIONS
Based on both subjective and objective measures, pessaries are an effective conservative treatment option for SUI. This supports pessary use, though larger studies with longer-term follow-up are warranted.
Topics: Child; Female; Humans; Pessaries; Surveys and Questionnaires; Urethra; Urinary Incontinence; Urinary Incontinence, Stress
PubMed: 35420550
DOI: 10.1097/SPV.0000000000001180 -
Journal of Obstetrics and Gynaecology... Dec 2023Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or... (Review)
Review
OBJECTIVES
Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or prevent pelvic organ prolapse. Vitamin D deficiency has consistently been associated with decreased muscle function, so it is assumed that it will affect the pelvic floor muscles. This paper systematically explores the differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
STUDY DESIGN
A systematic review was conducted through the PubMed, Google Scholar, Cochrane Library, and ScienceDirect databases using relevant keywords. Articles published in the last 10 years-from 2012 to 2022-that were written in English, that discuss the status or effect of vitamin D on pelvic organ prolapse, and that focus on 25 OH-vitamin D were included in the review.
RESULTS
In total, 717 articles were filtered but 8 articles met the criteria. A total of 1339 women with prolapse and without prolapse with ages ranging from 20 years to 78 years were included in the study. The studies found did not use the same standard threshold in determining deficiency status. Most studies have found that there are lower levels of vitamin D in women who have had pelvic organ prolapse. A total of 7 of 8 studies confirmed the comparison of vitamin D-25OH levels in women with pelvic organ prolapse and without pelvic organ prolapse at P < 0.05.
CONCLUSIONS
There are differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
Topics: Humans; Female; Pelvic Floor; Pelvic Organ Prolapse; Vitamin D; Calcifediol; Vitamins; Pessaries
PubMed: 37633644
DOI: 10.1016/j.jogc.2023.102198 -
International Journal of Gynaecology... May 2024Recent recommendations from the French High Authority of Health on pelvic organ prolapse (POP) management underline the value of a pelvic examination. (Review)
Review
BACKGROUND
Recent recommendations from the French High Authority of Health on pelvic organ prolapse (POP) management underline the value of a pelvic examination.
OBJECTIVES
The aim of this paper was to analyze the literature and identify the best evidence available regarding pelvic examination for women presenting prolapse-associated symptoms in terms of diagnosis and predictability of treatment success.
SEARCH STRATEGY
The databases were queried similarly using Medical Subject Headings (MeSH) and non-MeSH terms broadly related to pelvic examination and POP management.
SELECTION CRITERIA
We included studies assessing the diagnostic contribution of pelvic examination (correlation with symptoms) and its value for assessing the risk of pessary failure or recurrence after reconstructive surgery.
DATA COLLECTION AND ANALYSIS
We assessed peer-reviewed articles on PubMed, Embase, and Cochrane database up to May 2023. The methodological quality of all the included studies was assessed using the ROBINS-E or RoB2 tools.
MAIN RESULTS
In all, 67 studies were retained for the review. Prolapse-associated symptoms are poorly correlated with POP diagnosis. The symptom that is best correlated with the POP stage is the presence of a vaginal bulge (moderate to good correlation). The factors most strongly associated with the risk of recurrence after surgery or pessary failure are clinical: essentially a higher POP stage before surgery, levator ani muscle avulsion, and vaginal and genital measurements.
CONCLUSIONS
In women complaining of prolapse-associated symptoms, a pelvic examination (vaginal speculum and digital vaginal examination) can confirm the presence of POP and identify risk factors for treatment failure or recurrence after surgical management or pessary placement. A higher stage of POP and levator ani muscle avulsion-discernible on pelvic examination-are major risk factors for POP recurrence or treatment failure. These features must be taken into account in the treatment choice and discussed with the patient.
PubMed: 38778697
DOI: 10.1002/ijgo.15697 -
Acta Obstetricia Et Gynecologica... Nov 2020Several studies acknowledge that the presence of amniotic fluid sludge (AFS) is an independent predictive factor for preterm birth. In the present systematic review, we...
INTRODUCTION
Several studies acknowledge that the presence of amniotic fluid sludge (AFS) is an independent predictive factor for preterm birth. In the present systematic review, we summarize research that focuses on the comparison of pregnancy outcomes among women with and without AFS.
MATERIAL AND METHODS
Medline, Scopus, Clinicaltrials.gov, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar databases were systematically searched from inception. Both observational and randomized controlled studies were considered eligible provided that they reported data on pregnancy outcomes among women with and without AFS. Outcomes were not meta-analyzed because of the high heterogeneity in terms of selected population and outcome reporting.
RESULTS
Seventeen studies of 2432 women were included in this review. Six studies evaluated women at high risk for preterm birth. Pregnancies complicated by AFS had a lower gestational age at delivery and increased incidence of preterm delivery at <37 weeks. Neonatal death rates and admission to the Neonatal Intensive Care Unit were also increased. Evidence in low-risk women, those with signs of preterm labor, in those carrying twins, and in women with cervical cerclage or Arabin pessary was extremely limited.
CONCLUSIONS
Women with AFS seem to deliver at an earlier gestational age, and preterm birth rates are also increased. Limited data seem to point to neonatal morbidity and mortality being increased. However, the presence of a direct association should not be assumed because the evidence is not adjusted for the presence of confounders.
Topics: Amniotic Fluid; Female; Humans; Infant; Infant Mortality; Infant, Newborn; Pregnancy; Pregnancy Outcome; Premature Birth; Risk Factors; Uterine Cervical Incompetence
PubMed: 32367525
DOI: 10.1111/aogs.13893 -
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 -
Archivos Espanoles de Urologia Apr 2021Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. The pessary is a silicone device, inserted into the vagina to...
Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. The pessary is a silicone device, inserted into the vagina to provide support to the pelvic organs. It is used as a conservative treatment to improve prolapse symptoms.OBJECTIVES: To evaluate the effectiveness of pessary treatment in pelvic organ prolapse through a systematic review of the current literature.MATERIAL AND METHODS: A Scoping Review was carried out based on the PRISMA guidelines for the development of systematic reviews. The PICO research question was asked, the sources of information were selected, and the eligibility criteria were established. Subsequently, the descriptors in health sciences and keywords, combined with Boolean operators, were appliedin each of the search engines. RESULTS: A total of 19 references were included in the analysis of this work. To delimit the data extraction, the information was divided into four dimensions: improvements in symptoms related to POP and quality of life, sexual function; discontinuation, justification for discontinuation and complications. CONCLUSIONS: The pessary produces positive effects on the quality of life of women with POP, with good satisfaction rates. The main reasons for the interruption include: inability to retain the pessary, discomfort, and the desire for surgery.
Topics: Female; Humans; Pelvic Organ Prolapse; Pessaries; Quality of Life; Treatment Outcome; Vagina
PubMed: 33818427
DOI: No ID Found -
Progres En Urologie : Journal de... Nov 2020The aim was to synthesize current knowledge on overactive bladder (OAB) and female pelvic-perineal diseases.
INTRODUCTION
The aim was to synthesize current knowledge on overactive bladder (OAB) and female pelvic-perineal diseases.
METHOD
A systematic literature review based on PubMed, Embase and Google Scholar was conducted in April 2020.
RESULTS
Women with pelvic organ prolapse very often have OAB. Prolapse surgery should be considered if the prolapse is symptomatic and never be indicated in case of overactive bladder symptoms solely. In case of symptomatic prolapse and OAB, pessary and surgical treatments are effective on both pathologies up to 71 % of the cases. OAB may occur in parallel or as part of a menopausal genitourinary syndrome. In the latter case, only local estrogen therapy is effective. OAB may occur alongside stress urinary incontinence (SUI) or be integrated into mixed urinary incontinence. The initial treatment should be based on the most troublesome symptoms. In case of SUI, the outcome of surgical treatment on OAB remains uncertain. De novo, OAB follows prolapse or SUI surgery. It requires investigations to exclude urinary tract infection, bladder outlet obstruction or erosion. The treatment is the same as OAB.
CONCLUSION
The clinician's challenge is to draw a balance between the OAB and a pelvic-perineal pathology in order to adapt the treatment.
Topics: Algorithms; Female; Humans; Pelvic Organ Prolapse; Perineum; Syndrome; Urinary Bladder, Overactive; Urinary Incontinence, Stress
PubMed: 33220817
DOI: 10.1016/j.purol.2020.08.053 -
Ontario Health Technology Assessment... 2021Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most...
BACKGROUND
Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, and patient preferences and values.
METHODS
We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using ROBIS, the Cochrane Risk of Bias tool, and the Newcastle-Ottawa Scale and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding vaginal pessaries for individuals with pelvic organ prolapse and/or stress urinary incontinence in Ontario. We explored the underlying values, needs, and priorities of those who have lived experience with POP and/or SUI, as well as the preferences and perceptions of both patients and providers of vaginal pessaries.
RESULTS
We included 15 studies in the clinical evidence review. Compared with no treatment for people with SUI, pessaries were associated with a significant improvement in some symptoms at 14 days follow-up (SUI subscore of Urinary Symptom Profile, mean difference -2.20; 95% CI -3.47 to -0.93; GRADE: Very low). Compared with pelvic floor muscle training (PFMT), pessaries were associated with no difference in improvement at 12 months follow-up for some symptoms (Urinary Distress Inventory subscale of the Pelvic Floor Distress Inventory, risk ratio = 0.86; 95% CI 0.64 to 1.16; GRADE: Low). For people with POP, pessaries were associated with a significant improvement in the Pelvic Organ Prolapse Distress Inventory score and in sexual function compared with PFMT plus feedback/electrical stimulation/lifestyle advice at 12- and 24-month follow ups (GRADE: Low). Pessary continuation rate at 12 months follow up was reported to be 60% (44/74 patients) (GRADE: Very low).When evaluating various POP and SUI treatments in sequential order, pessaries were within the most cost-effective treatment sequence; therefore, it is likely to be a cost-effective intervention for treating POP and SUI. There was a high degree of certainty that pessaries were cost-effective in a population with POP, and a moderate degree of certainty in a population with SUI. When the treatment sequence of pessaries and surgery was compared with surgery alone, the pessaries treatment sequence dominates surgery in the cohort with POP, and in the cohort with SUI pessaries had an incremental cost-effectiveness ratio (ICER) of $1,033 per QALY gained. The annual budget impact of publicly funding vaginal pessaries in Ontario over the next 5 years ranges from $0.3 million in year 1 to $0.5 million in year 5 for POP, and $0.2 million in year 1 to $0.3 million in year 5 for SUI.We included one study in our quantitative evidence review and spoke to 29 people in our direct patient engagement. The evidence indicated that patient preferences vary and that patients accept the risks of their chosen treatment option. The 24 people we spoke with who had direct experience with vaginal pessaries reported that their POP and/or SUI limited their social activities and restricted their activity levels, taking a huge emotional toll. Many were hesitant or even fearful of surgery due to side effects and perceived failure rate of the surgery. Most people reported that pessaries relieved most or all of their symptoms, allowing them to return to their normal daily activities. However, wait times for pessary fittings could be as long as 2 years, and out-of-pocket expenses could be a barrier for people without extended insurance.
CONCLUSIONS
For people with SUI, vaginal pessaries may improve symptoms compared with no treatment, but the evidence is very uncertain. Pessaries may result in little to no difference in longer-term improvement of SUI symptoms compared with PFMT. For people with POP, pessaries may improve some longer-term symptoms, as well as sexual function compared with PFMT. For people with symptomatic POP and SUI, vaginal pessaries may be a cost-effective intervention to be used within a stepped care model (a sequence of interventions followed after the current treatment proves ineffective). We estimate that publicly funding vaginal pessaries in Ontario would result in a total 5-year budget impact of $2.0 million for POP and $1.3 million for SUI. People with POP and/or SUI reported pessary use as being an effective treatment option to manage their symptoms.
Topics: Female; Humans; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Technology Assessment, Biomedical; Urinary Incontinence, Stress
PubMed: 34055111
DOI: No ID Found -
Reproductive Biology and Endocrinology... Jul 2021Various luteal phase supports (LPSs) have been proven to increase the pregnancy rate in fresh cycles of in vitro fertilization or intracytoplasmic sperm injection;... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Various luteal phase supports (LPSs) have been proven to increase the pregnancy rate in fresh cycles of in vitro fertilization or intracytoplasmic sperm injection; however, there is still significant debate regarding the optimal use of LPS.
METHODS
A systematic review with the use of a network meta-analysis was performed via electronic searching of Ovid MEDLINE, the Cochrane Library, Embase, Web of Science, ClinicalTrials.gov and Google Scholar (up to January 2021) to compare the effectiveness and safety of various LPSs, as well as to evaluate the effects of different initiations of LPSs on pregnancy outcomes. The primary outcomes included live birth and ongoing pregnancy, with the results presented as odds ratios (ORs) with 95% confidence intervals (CIs).
RESULTS
Eighty-nine randomized controlled trials with 29,625 women comparing 14 interventions or placebo/no LPS treatments were included in the meta-analyses. No significant differences were found in terms of the pregnancy outcomes when LPS was started within 48 h after oocyte retrieval versus a delayed initiation between 48 h and 96 h after oocyte retrieval. The addition of gonadotropin-releasing hormone (GnRH) agonists to progesterone vaginal pessaries showed a significant benefit in terms of live birth (OR 1.39, 95% CI 1.08 to 1.78). Only human chorionic gonadotropin (HCG) was found to be more efficacious than the placebo/no LPS treatment in terms of live birth (OR 15.43, 95% CI 2.03 to 117.12, low evidence). Any active LPSs (except for rectal or subcutaneous progesterone) was significantly more efficacious than the placebo/no LPS treatment in terms of ongoing pregnancy, with ORs ranging between 1.77 (95% CI 1.08 to 2.90) for the vaginal progesterone pessary and 2.14 (1.23 to 3.70) for the intramuscular progesterone treatment. Among the comparisons of efficacy and tolerability between the active treatments, the differences were small and very uncertain.
CONCLUSION
Delays in progesterone supplementation until 96 h after oocyte retrieval does not affect pregnancy outcomes. The safety of GnRH agonists during the luteal phase needs to be evaluated in future studies before the applications of these agonists in clinical practice. With comparable efficacy and acceptability, there may be several viable clinical options for LPS.
Topics: Adult; Female; Fertilization in Vitro; Humans; Infertility, Female; Live Birth; Luteal Phase; Pregnancy; Pregnancy Rate; Randomized Controlled Trials as Topic; Sperm Injections, Intracytoplasmic
PubMed: 34229723
DOI: 10.1186/s12958-021-00782-5 -
Journal of Perinatal Medicine Jun 2024We aimed to perform a systematic review and network meta-analysis to evaluate the preventive strategies for preterm birth in twin-to-twin transfusion syndrome.
OBJECTIVES
We aimed to perform a systematic review and network meta-analysis to evaluate the preventive strategies for preterm birth in twin-to-twin transfusion syndrome.
METHODS
PubMed, Embase and Cochrane Central were searched from inception to December 2023 with no filters. Additionally, the reference lists of the included studies were manually examined to identify any supplementary studies. We selected randomized controlled trials and cohorts comparing interventions to prevent preterm birth in twin pregnancies complicated by twin-to-twin transfusion syndrome. A random-effects frequentist network meta-analysis was performed using RStudio version 4.3.1. Randomized controlled trials and cohorts were assessed respectively using the Risk of Bias in Non-randomized Studies of interventions tool and Cochrane Collaboration's tool for assessing risk of bias in randomized trials.
RESULTS
In this systematic review and meta-analysis, we included eight studies comprising a total of 719 patients. Compared with expectant management, cerclage stood out as the only intervention associated with an increase in the survival of at least one twin (risk ratio 1.12; 95 % confidence interval 1.01-1.23). Our subgroup analysis based on different thresholds for short cervix demonstrated a significant reduction in the risk of preterm birth before 32 weeks with ultrasound-indicated cerclage using a 15 mm criterion (risk ratio 0.65; 95 % confidence interval 0.47-0.92).
CONCLUSIONS
Our study suggests the potential benefit of cerclage as a preventive strategy for preterm birth in pregnancies complicated by twin-to-twin transfusion syndrome. These findings highlight the necessity for further investigation to corroborate our results and address the optimal threshold for ultrasound-indicated cerclage.
PubMed: 38905455
DOI: 10.1515/jpm-2024-0119