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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 -
European Urology Focus Sep 2022While the management of bladder outlet obstruction (BOO) in men has been a topic of several systematic reviews and meta-analyses, no such evidence base exists for female... (Review)
Review
Benefits and Harms of Conservative, Pharmacological, and Surgical Management Options for Women with Bladder Outlet Obstruction: A Systematic Review from the European Association of Urology Non-neurogenic Female LUTS Guidelines Panel.
CONTEXT
While the management of bladder outlet obstruction (BOO) in men has been a topic of several systematic reviews and meta-analyses, no such evidence base exists for female BOO.
OBJECTIVE
The aim of this systematic review was to evaluate the benefits and harms of therapeutic interventions for the management of BOO in women.
EVIDENCE ACQUISITION
This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. The study protocol was registered with PROSPERO (CRD42020183839). A systematic literature search was performed and updated by a research librarian in May 2021. The study population consisted of adult female patients diagnosed with BOO, who underwent treatment.
EVIDENCE SYNTHESIS
Out of 6344 records, we identified 33 studies enrolling 1222 participants, of which only six randomized controlled trials (RCTs) were found. One placebo-controlled crossover randomized trial assessed the role of baclofen in 60 female patients with dysfunctional voiding. The trial met its primary endpoint with a significantly greater decrease in the number of voids per day in the baclofen group (-5.53 vs -2.70; p = 0.001). The adverse events were mild and comparable in both groups (25% vs 20%). One placebo-controlled crossover randomized trial assessed the role of sildenafil in 20 women with Fowler's syndrome. There were significant improvements from baseline in maximum urinary flow rate (Qmax), International Prostate Symptom Score (IPSS), and postvoid residual (PVR), but with no statistically significant difference when compared with placebo. In a large RCT including 197 female patients with functional BOO, the alpha-blocker alfuzosin significantly improved IPSS, Qmax, and PVR compared with baseline, but the differences were not statistically significant compared with the placebo group. Several small single-arm prospective series reported improvement of BOO-related symptoms and voiding parameters with urethroplasty, sling revision, urethral dilation, vaginal pessary, and pelvic organ prolapse repair.
CONCLUSIONS
Evidence to support the use of conservative, pharmacological, and surgical treatments for BOO is scarce.
PATIENT SUMMARY
According to the present systematic review of the literature, evidence to support the use of conservative, pharmacological, and surgical treatments for either anatomical or functional bladder outlet obstruction is scarce.
Topics: Male; Adult; Female; Humans; Urinary Bladder Neck Obstruction; Urodynamics; Urology; Baclofen; Urinary Bladder
PubMed: 34702649
DOI: 10.1016/j.euf.2021.10.006 -
The Cochrane Database of Systematic... Dec 2014Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management, particularly when a woman does not want surgery or when she is considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment.
OBJECTIVES
To determine whether mechanical devices are useful in the management of adult female urinary incontinence.
SEARCH METHODS
For this second update we searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 21 August 2014), EMBASE (January 1947 to 2014 Week 34), CINAHL (January 1982 to 25 August 2014), and the reference lists of relevant articles.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined by symptom, sign or urodynamic diagnosis.
DATA COLLECTION AND ANALYSIS
The reviewers assessed the identified studies for eligibility and risk of bias and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 5.3).
MAIN RESULTS
One new trial was identified and included in this update bringing the total to eight trials involving 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Four trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. One trial compared three groups: a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure.
AUTHORS' CONCLUSIONS
The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.
Topics: Adult; Aged; Exercise Therapy; Female; Humans; Middle Aged; Muscle Contraction; Pelvic Floor; Pessaries; Prostheses and Implants; Randomized Controlled Trials as Topic; Tampons, Surgical; Urinary Incontinence; Urinary Sphincter, Artificial
PubMed: 25517397
DOI: 10.1002/14651858.CD001756.pub6 -
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 -
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 -
European Journal of Obstetrics,... Apr 2020To identify the knowledge, attitudes and practice of women and healthcare professionals in relation to pessary use for POP. (Review)
Review
OBJECTIVE
To identify the knowledge, attitudes and practice of women and healthcare professionals in relation to pessary use for POP.
METHOD
This systematic review was carried out in agreement with PRISMA recommendations. PubMed/MEDLINE, SCOPUS, Virtual Health Library, Web of Science, CAPES Periodicals and CINAHL databases were searched for studies without date or language limitations. Search strategies were developed for identifying studies examining knowledge, attitudes and practice toward vaginal pessaries use. Two reviewers independently screened titles and abstracts to identify eligible studies. Data extraction was performed independently in duplicate into a standardized form. Quality of included studies was assessed using the Joanna Briggs Institute quality assessment tool. The protocol was registered with the PROSPERO International prospective register of systematic reviews [CRD42018114236].
RESULTS
Fourteen studies were included. Knowledge and practice were the main domains investigated among patients and professionals, respectively. The results demonstrated poor patient knowledge; however, in urogynecologic patients, knowledge was better. Previous consultation with a Female Pelvic Medicine and Reconstructive Surgery specialist (p = .001) and a higher level of education (p = .006) were associated with improved knowledge of pessary use. Fear of vaginal discharge, irritation, bleeding, and pain were factors that supported the decision not to use a pessary. Previous consultation with a generalist gynecologist (p = .03)and a lower level of education (p = .03) predicted aversion to pessary use. Providers demonstrated adequate knowledge and recommended pessary in 86.4% to 98.0% of cases. Having specialist and pessary management training were some factors that influenced a better attitude towards pessaries among health professionals.
CONCLUSION
The knowledge, attitudes and practice of women and health care providers about pessary use are seldom investigated. Developing a psychometrically valid instrument for assessment of knowledge, attitudes and practice is desirable to examine the complex interactions between these three constructs, expose barriers to pessary care, and develop targeted educational interventions.
Topics: Female; Health Knowledge, Attitudes, Practice; Humans; Pelvic Organ Prolapse; Pessaries
PubMed: 32113060
DOI: 10.1016/j.ejogrb.2020.02.016 -
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 -
Journal of Clinical Medicine Dec 2022Introduction: Quality of life (QoL) improvement is one of the main outcomes in the management of pelvic organ prolapse as a chronic illness in women. This systematic... (Review)
Review
Introduction: Quality of life (QoL) improvement is one of the main outcomes in the management of pelvic organ prolapse as a chronic illness in women. This systematic review aimed to investigate the impact of surgical or pessary treatment for pelvic organ prolapse (POP) on quality of life. Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was applied. Electronic databases, including PubMed, Scopus, and Web of Science, were searched for original articles that evaluated the QoL before and after surgical interventions or pessary in pelvic organ prolapse from 1 January 2012 until 30 June 2022 with a combination of proper keywords. Included studies were categorized based on interventions, and they were tabulated to summarize the results. Results: Overall, 587 citations were retrieved. Of these, 76 articles were found eligible for final review. Overall, three categories of intervention were identified: vaginal surgeries (47 studies), abdominal surgeries (18 studies), and pessary intervention (11 studies). Almost all interventions were associated with improved quality of life. The results of the meta-analysis showed a significant association between the employment of surgical approach techniques (including vaginal and abdominal surgeries) and the quality of life (Pelvic Floor Distress Inventory (PFDI) (MD: −48.08, 95% CI: −62.34 to −33.77, p-value < 0.01), Pelvic Floor Impact Questionnaire (PFIQ) (MD: −33.41, 95% CI: −43.48 to −23.34, p < 0.01)) and sexual activity of patients with pelvic organ prolapse (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) (MD: 4.84, 95% CI: 1.75 to 7.92, p < 0.01)). Furthermore, narrative synthesis for studies investigating the effect of the pessary approach showed a positive association between the use of this instrument and improvement in the quality of life and sexual activity. Conclusions: The results of our study revealed a significant improvement in the women’s quality of life following abdominal and vaginal reconstructive surgery. The use of pessary was also associated with increased patient quality of life.
PubMed: 36498740
DOI: 10.3390/jcm11237166 -
The Journal of Maternal-fetal &... Jan 2022To evaluate the effectiveness of cervical pessary in preventing preterm birth (PTB) and improving perinatal outcomes among singleton and twin pregnancies. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To evaluate the effectiveness of cervical pessary in preventing preterm birth (PTB) and improving perinatal outcomes among singleton and twin pregnancies.
METHODS
Electronic databases were systematically searched from their inception until 14 March 2019. Randomized clinical trials comparing the effectiveness of cervical pessary placement with expectant management were included. The primary outcome was the incidence of PTB <34 weeks.
RESULTS
Thirteen studies were included, involving eight studies about singleton and six studies about twin pregnancies. For singleton pregnancies with short cervical length, cervical pessary, comparing with expectant treatment, seemed have no effectiveness in preventing PTB <34 weeks (relative risk, 95% confidence interval, 0.73, 0.42-1.28), <37 weeks (0.69, 0.43-1.09), and <28 weeks (0.79, 0.42-1.48); while for twin pregnancies with short cervical length, cervical pessary also did not reduce the risk of PTB <34 weeks (0.81, 0.49-1.35), <37 weeks (0.93, 0.83-1.05), and <28 weeks (0.72, 0.38-1.38). However, cervical pessary seemed have the effectiveness of reducing the risk of spontaneous PTB <28 weeks (0.50, 0.25-0.99) and low birth weight (<1500 g) (0.68, 0.50-0.94) among twin pregnancies with short cervical length. In addition, cervical pessary increased the rate of vaginal discharge and did not improve perinatal outcomes among both singleton and twin pregnancies.
CONCLUSIONS
Comparing with the expectant treatment, the effectiveness of cervical pessary for reducing the risk of PTB remains uncertain. Additional trials are warranted to further evaluate the effectiveness of cervical pessary.
Topics: Cervix Uteri; Female; Humans; Infant, Low Birth Weight; Infant, Newborn; Pessaries; Pregnancy; Pregnancy, Twin; Premature Birth
PubMed: 31948303
DOI: 10.1080/14767058.2020.1712705 -
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