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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... Jul 2023Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at... (Review)
Review
BACKGROUND
Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at least one child, and recognised risk factors are older age, higher number of births, and higher body mass index. This review assesses the effects of oestrogen therapy, alone or in combination with other treatments, on POP in postmenopausal women.
OBJECTIVES
To assess the benefits and harms of local and systemic oestrogen therapy in the management of pelvic organ prolapse symptoms in postmenopausal women, and to summarise the principal findings of relevant economic evaluations.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register (up to 20 June 2022), which includes CENTRAL, MEDLINE, two trials registers, and handsearching of journals and conference proceedings. We also checked the reference lists of relevant articles for additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), quasi-RCTs, multi-arm RCTs, and cross-over RCTs that evaluated the effects of oestrogen therapy (alone or in combination with other treatments) versus placebo, no treatment, or other interventions in postmenopausal women with any grade of POP.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from the included trials using prespecified outcome measures and a piloted extraction form. The same review authors independently assessed the risk of bias of eligible trials using Cochrane's risk of bias tool. Had data allowed, we would have created summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE.
MAIN RESULTS
We identified 14 studies including a total of 1002 women. In general, studies were at high risk of bias in terms of blinding of participants and personnel, and there were also some concerns about selective reporting. Owing to insufficient data for the outcomes of interest, we were unable to perform our planned subgroup analyses (systemic versus topical oestrogen, parous versus nulliparous women, women with versus without a uterus). No studies assessed the effects of oestrogen therapy alone versus no treatment, placebo, pelvic floor muscle training, devices such as vaginal pessaries, or surgery. However, we did identify three studies that assessed oestrogen therapy in conjunction with vaginal pessaries versus vaginal pessaries alone and 11 studies that assessed oestrogen therapy in conjunction with surgery versus surgery alone.
AUTHORS' CONCLUSIONS
There was insufficient evidence from RCTs to draw any solid conclusions on the benefits or harms of oestrogen therapy for managing POP symptoms in postmenopausal women. Topical oestrogen in conjunction with pessaries was associated with fewer adverse vaginal events compared with pessaries alone, and topical oestrogen in conjunction with surgery was associated with reduced postoperative urinary tract infections compared with surgery alone; however, these findings should be interpreted with caution, as the studies that contributed data varied substantially in their design. There is a need for larger studies on the effectiveness and cost-effectiveness of oestrogen therapy, used alone or in conjunction with pelvic floor muscle training, vaginal pessaries, or surgery, for the management of POP. These studies should measure outcomes in the medium and long term.
Topics: Female; Humans; Middle Aged; Estrogens; Pelvis; Pessaries; Postmenopause; Urinary Bladder
PubMed: 37431855
DOI: 10.1002/14651858.CD014592.pub2 -
Safety of misoprostol vs dinoprostone for induction of labor: A systematic review and meta-analysis.European Journal of Obstetrics,... Oct 2023Pharmacological agents such as prostaglandins (dinoprostone and misoprostol) are commonly used to reduce the duration of labor and promote vaginal delivery. However, key... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Pharmacological agents such as prostaglandins (dinoprostone and misoprostol) are commonly used to reduce the duration of labor and promote vaginal delivery. However, key safety considerations with its use include an increased risk of uterine rupture, tachysystole and hyperstimulation of pregnant women, which could potentially lead to a non-reassuring fetal heart rate and to fetal hypoxemia. The aim of this systematic review was to assess maternal and fetal outcomes between misoprostol group (PGE1) and dinoprostone group (PGE2) STUDY DESIGN: We search on MEDLINE (PubMed), CINHAL (EBSCOhost), EMBASE, Scopus (Ovid), CENTRAL (January 1, 1998, to December 31, 2022). Patients were eligible if they presented at greater than 36 weeks gestation with an indication for induction of labor and a single live cephalic fetus. We conducted a meta-analysis of data for both primary (cesarean section rate, instrumental deliveries rate, tachysystole, uterine rupture, post-partum haemorrage; chorionamiositis) and secondary outcomes (Apgar at 5 min <7, meconium-stained liquor, NICU admission, infant death) using odds-ratio (OR) as a measure of effect-size. Risk of bias assessment was performed with RoB-I. We performed statistical analyses using Cochrane RevMan version 5.4 software.
RESULTS
We found 39 RCTs comparing the outcomes of interest between misoprostol and dinoprostone. The pooled effect showed no statistically significant difference between the two groups in terms of cesarean section rate [OR: 0.94; 95% CI 0.84-1.05], instrumental deliveries rate [OR: 1.04; 95% CI: 0.90-1.19; p = 0.62], tachysystole [OR: 1.21; 95% CI: 0.91-1.60; p = 0.19], post-partum hemorrhage [OR: 0.85; 95% CI: 0.62-1.15p = 0.30], chorioamnionitis [OR: 0.94; 95% CI: 0.76-1.17p = 0.59], Apgar at 5 min < 7 [OR: 0.83; 95% CI: 0.61-1.12, p = 0.21], meconium-stained liquor [OR: 1.11; 95% CI: 0.97-1.27p = 0.59], NICU admission group [OR: 0.91; 95% CI: 0.77-1.09], infant death [OR: 0.57; 95% CI: 0.22-1.44]. After performing a sub-group analysis based on the type of prostaglandins administrations (oral, vaginal gel, vaginal pessary), results did not change substantially.
CONCLUSIONS
This systematic review and meta-analysis demonstrate that misoprostol and dinoprostone appear to have a similar safety profile.
Topics: Infant; Humans; Female; Pregnancy; Dinoprostone; Misoprostol; Cesarean Section; Uterine Rupture; Prostaglandins; Oxytocics; Abortifacient Agents, Nonsteroidal; Infant Death; Labor, Induced
PubMed: 37660506
DOI: 10.1016/j.ejogrb.2023.08.382 -
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 -
International Journal of Gynaecology... Apr 2024Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies. (Review)
Review
BACKGROUND
Prediction of pregnancies at risk of preterm birth (PTB) may allow targeted prevention strategies.
OBJECTIVES
To assess quality of clinical practice guidelines (CPGs) and identify areas of agreement and contention in prediction and prevention of spontaneous PTB.
SEARCH STRATEGY
We searched for CPGs regarding PTB prediction and prevention in asymptomatic singleton pregnancies without language restriction in January 2024.
SELECTION CRITERIA
CPGs included were published between July 2017 and December 2023 and contained statements intended to direct clinical practice.
DATA COLLECTION AND ANALYSIS
CPG quality was assessed using the AGREE-II tool. Recommendations were extracted and grouped under domains of prediction and prevention, in general populations and high-risk groups.
MAIN RESULTS
We included 37 CPGs from 20 organizations; all were of moderate or high quality overall. There was consensus in prediction of PTB by identification of risk factors and cervical length screening in high-risk pregnancies and prevention of PTB by universal screening and treatment for asymptomatic bacteriuria, screening and treatment for BV in high-risk pregnancies, and use of preventative progesterone and cerclage. Areas of contention or limited consensus were the role of PTB clinics, universal cervical length measurement, biomarkers and cervical pessaries.
CONCLUSIONS
This review identified strengths and limitations of current PTB CPGs, and areas for future research.
PubMed: 38619379
DOI: 10.1002/ijgo.15514 -
Archives of Gynecology and Obstetrics Nov 2023Levator ani muscle (LAM) avulsion affects up to 35% of women. Unlike obstetric anal sphincter injury, LAM avulsion is not diagnosed immediately after vaginal delivery,... (Review)
Review
PURPOSE
Levator ani muscle (LAM) avulsion affects up to 35% of women. Unlike obstetric anal sphincter injury, LAM avulsion is not diagnosed immediately after vaginal delivery, however, has a profound impact on quality of life. The management of pelvic floor disorders is in growing demand yet the significance of LAM avulsion in the context of pelvic floor dysfunction (PFD) is poorly understood. This study collates information on success of treatment for LAM avulsion to establish the best options for management of women.
METHODS
MEDLINE, MEDLINE In-Process, EMBASE, PubMed, CINAHL and The Cochrane Library were searched for articles that evaluated the management techniques used to treat LAM avulsion. The protocol was registered with PROSPERO (CRD42021206427).
RESULTS
Natural healing of LAM avulsion occurs in 50% of women. Conservative measures, including pelvic floor exercises and pessary use are poorly studied. Pelvic floor muscle training for major LAM avulsions was of no benefit. Post-partum pessary use was only of benefit in the first three months for women. Surgeries for LAM avulsion are poorly researched but studies suggest they may provide benefit for 76-97% of patients.
CONCLUSIONS
Whilst some women with PFD secondary to LAM avulsion improve spontaneously, 50% continue to have pelvic floor symptoms 1 year following delivery. These symptoms result in a significant negative impact on quality of life, however, it is not clear whether conservative or surgical methods are helpful. There is a pressing need for research to find effective treatments and explore appropriate surgical repair techniques for women with LAM avulsion.
Topics: Pregnancy; Humans; Female; Quality of Life; Postpartum Period; Anal Canal; Pelvic Floor Disorders; Delivery, Obstetric; Ultrasonography
PubMed: 36808288
DOI: 10.1007/s00404-023-06955-4 -
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 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 -
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 -
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