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Obstetrics and Gynecology Oct 2022To evaluate the existing evidence on the efficacy of pessaries in improving quality of life when used for the treatment of pelvic organ prolapse (POP). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the existing evidence on the efficacy of pessaries in improving quality of life when used for the treatment of pelvic organ prolapse (POP).
DATA SOURCES
We searched for the terms "pelvic organ prolapse" and "pessar/y/ies/ium or vaginal support device," and "safety or safe or outcome or complication or efficacy or effective or effectiveness" in PubMed, EMBASE, and CINAHL on March 16, 2020. A search was also performed on ClinicalTrials.gov , with no studies fitting our strict inclusion and exclusion criteria.
METHODS OF STUDY SELECTION
Studies that reported pretreatment and posttreatment mean scores and SDs after pessary treatment for standardized questionnaires were included. Studies performed in pediatric populations, pregnancy, and use of pessaries not for prolapse were excluded. Three reviewers independently screened studies.
TABULATION, INTEGRATION, AND RESULTS
Data abstraction was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Data were pooled for meta-analysis when reported by at least three studies. The primary study outcome was change in mean pretreatment and posttreatment questionnaire scores, which included those for the PFDI-20 (Pelvic Floor Distress Inventory- Short Form 20), PFIQ-7 (Pelvic Floor Impact Questionnaire - Short Form 7), and subscale POPIQ (Pelvic Organ Prolapse Impact Questionnaire Long Form). A random-effects model was used to combine estimates and capture between-study heterogeneity using the I 2 -statistic. Eight studies including 627 patients were included for systematic review. The mean (SD) age was 63.0±12.2 years, and the majority of patients had stage III prolapse (48.1%) followed by stage II prolapse (43.2%) when reported. Although variable, the majority of studies conducted 3-month follow-up. A negative change in pretreatment and posttreatment scores was noted, signifying improvement after pessary use: PFDI-20 mean change -46.1 (95% CI -65.4 to -26.8); PFIQ-7 mean change -36.0 (95% CI -46.0 to -26.0); POPIQ-7 (Pelvic Organ Prolapse Impact Questionnaire-7) mean change -16.3 (95% CI -26.8 to -5.7). No significant heterogeneity was found.
CONCLUSION
Based on improvements in standardized questionnaire scores, pessaries are effective treatment options for POP.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020172618.
Topics: Female; Child; Humans; Middle Aged; Aged; Pessaries; Quality of Life; Pelvic Organ Prolapse; Pelvic Floor; Surveys and Questionnaires; Treatment Outcome
PubMed: 36075076
DOI: 10.1097/AOG.0000000000004931 -
BMJ Clinical Evidence Mar 2012Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59... (Review)
Review
INTRODUCTION
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with anterior vaginal wall prolapse? What are the effects of surgical treatments in women with posterior vaginal wall prolapse? What are the effects of surgical treatments in women with upper vaginal wall prolapse? What are the effects of using different surgical materials in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 15 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension; abdominal sacral colpopexy; abdominal sacrohysteropexy; anterior colporrhaphy with mesh reinforcement; laparoscopic surgery; mesh or synthetic grafts; native (autologous) tissue; open abdominal surgery; pelvic floor muscle exercises; posterior colporrhaphy (with or without mesh reinforcement); posterior intravaginal slingplasty (infracoccygeal sacropexy); sacrospinous colpopexy (vaginal sacral colpopexy); sutures; traditional anterior colporrhaphy; transanal repair; ultralateral anterior colporrhaphy alone or with cadaveric fascia patch; vaginal hysterectomy; vaginal oestrogen; vaginal pessaries; and vaginal sacrospinous colpopexy.
Topics: Female; Gynecologic Surgical Procedures; Humans; Hysterectomy, Vaginal; Incidence; Pelvic Floor; Prolapse; Surgical Mesh; Uterine Prolapse; Vagina
PubMed: 22414610
DOI: No ID Found -
BJOG : An International Journal of... Jul 2017Preterm birth (PTB) is the leading cause of infant death, but it is unclear which intervention is best to prevent it. (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Preterm birth (PTB) is the leading cause of infant death, but it is unclear which intervention is best to prevent it.
OBJECTIVES
To compare progesterone, cerclage and pessary, determine their relative effects and rank them.
SEARCH STRATEGY
We searched Medline, EMBASE, CINAHL, Cochrane CENTRAL and Web of Science (to April 2016), without restrictions, and screened references of previous reviews.
SELECTION CRITERIA
We included randomised trials of progesterone, cerclage or pessary for preventing PTB in women with singleton pregnancies at risk as defined by each study.
DATA COLLECTION AND ANALYSIS
We extracted data by duplicate using a piloted form and performed Bayesian random-effects network meta-analyses and pairwise meta-analyses. We rated evidence quality using GRADE, ranked interventions using SUCRA and calculated numbers needed to treat (NNT).
MAIN RESULTS
We included 36 trials (9425 women; 25 low risk of bias trials). Progesterone ranked first or second for most outcomes, reducing PTB < 34 weeks [odds ratio (OR) 0.44; 95% credible interval (CrI) 0.22-0.79; NNT 9; low quality], <37 weeks (OR 0.58; 95% CrI 0.41-0.79; NNT 9; moderate quality), and neonatal death (OR 0.50; 95% CrI 0.28-0.85; NNT 35; high quality), compared with control, in women overall at risk. We found similar results in the subgroup with previous PTB, but only a reduction of PTB < 34 weeks in women with a short cervix. Pessary showed inconsistent benefit and cerclage did not reduce PTB < 37 or <34 weeks.
CONCLUSIONS
Progesterone was the best intervention for preventing PTB in singleton pregnancies at risk, reducing PTB < 34 weeks, <37 weeks, neonatal demise and other sequelae.
TWEETABLE ABSTRACT
Progesterone was better than cerclage and pessary to prevent preterm birth, neonatal death and more in network meta-analysis.
Topics: Administration, Intravaginal; Adult; Bayes Theorem; Cerclage, Cervical; Female; Gestational Age; Humans; Infant, Newborn; Network Meta-Analysis; Pessaries; Pregnancy; Premature Birth; Progesterone; Progestins; Randomized Controlled Trials as Topic; Risk Factors; Treatment Outcome
PubMed: 28276151
DOI: 10.1111/1471-0528.14624 -
International Urogynecology Journal Dec 2016The purpose of this systematic review is to assess the impact of pessary use on the quality of life of women with pelvic organ prolapse, and to determine the... (Review)
Review
INTRODUCTION AND HYPOTHESIS
The purpose of this systematic review is to assess the impact of pessary use on the quality of life of women with pelvic organ prolapse, and to determine the satisfaction rate and rationale for discontinuation.
METHODS
This review is recorded in the PROSPERO database under number CRD42015023384. The criteria for inclusion were observational study; cross section; cohort study; randomized controlled trial; study published in English, Portuguese, and Spanish; and study whose participants are women with female pelvic organ prolapse treated using a pessary. We did not include limitations on the year of publication. The criteria for exclusion included studies that did not include the topic, bibliographic or systematic reviews and articles that did not use validated questionnaires. The MeSH terms were "Pelvic Organ Prolapse AND Pessaries AND Quality of Life" OR "Pessary AND Quality of Life" OR "Pessaries".
RESULTS
We found 89 articles. After the final analyses, seven articles were included. All articles associated pessary use with improved quality of life, and all used only validated questionnaires. Over half of the women continued using the pessary during the follow-up with acceptable levels of satisfaction. The main rationales for discontinuation were discomfort, pain in the area, and expulsion of the device.
CONCLUSION
This systematic review demonstrates that the pessary can produce a positive effect on women's quality of life and can significantly improve sexual function and body perception.
Topics: Female; Humans; Patient Satisfaction; Pelvic Organ Prolapse; Pessaries; Quality of Life
PubMed: 26992725
DOI: 10.1007/s00192-016-2991-y -
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 -
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 -
BMJ Clinical Evidence Nov 2009Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59... (Review)
Review
INTRODUCTION
Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with anterior vaginal wall prolapse? What are the effects of surgical treatments in women with posterior vaginal wall prolapse? What are the effects of surgical treatments in women with upper vaginal wall prolapse? What are the effects of using different surgical materials in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 14 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension; abdominal sacral colpopexy; abdominal sacrohysteropexy; anterior colporrhaphy with mesh reinforcement; laparoscopic surgery; mesh or synthetic grafts; native (autologous) tissue; open abdominal surgery; pelvic floor muscle exercises; posterior colporrhaphy (with or without mesh reinforcement); posterior intravaginal slingplasty (infracoccygeal sacropexy); sacrospinous colpopexy (vaginal sacral colpopexy); sutures; traditional anterior colporrhaphy; transanal repair; ultralateral anterior colporrhaphy alone or with cadaveric fascia patch; vaginal hysterectomy; vaginal oestrogen; vaginal pessaries; and vaginal sacrospinous colpopexy.
Topics: Female; Gynecologic Surgical Procedures; Humans; Hysterectomy, Vaginal; Incidence; Pelvic Floor; Prolapse; Surgical Mesh; Transplants; Uterine Prolapse; Vagina
PubMed: 21726473
DOI: No ID Found -
BMJ Clinical Evidence Mar 2007Prolapse of the uterus or vagina is usually the result of loss of pelvic muscle support, and causes mainly non-specific symptoms. It may affect over half of women aged... (Review)
Review
INTRODUCTION
Prolapse of the uterus or vagina is usually the result of loss of pelvic muscle support, and causes mainly non-specific symptoms. It may affect over half of women aged 50-59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library and other important databases up to August 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found four systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension, abdominal sacral colpopexy, abdominal sacrohysteropexy, anterior colporrhaphy with mesh reinforcement, laparoscopic surgery, mesh or synthetic grafts, native (autologous) tissue, open abdominal surgery, pelvic floor muscle exercises, posterior colporrhaphy (with or without mesh reinforcement), posterior intravaginal slingplasty (infracoccygeal sacropexy), sacrospinous colpopexy (vaginal sacral colpopexy), sutures, traditional anterior colporrhaphy, transanal repair, ultralateral anterior colporrhaphy alone or with cadaveric fascia patch, vaginal hysterectomy, vaginal oestrogen, vaginal pessaries, and vaginal sacrospinous colpopexy.
Topics: Cystocele; Female; Gynecologic Surgical Procedures; Humans; Hysterectomy, Vaginal; Laparoscopy; Pessaries; Prolapse; Surgical Mesh; Transplants; Uterine Prolapse; Vagina
PubMed: 19454058
DOI: No ID Found -
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 -
The Cochrane Database of Systematic... May 2013Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical... (Review)
Review
BACKGROUND
Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still controversy regarding the efficacy and the group of patients that could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
OBJECTIVES
To evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 September 2012), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (1 September 2012).
SELECTION CRITERIA
We selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials. Cluster-randomised or cross-over trials were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion.
MAIN RESULTS
The review included one randomised controlled trial. The study included 385 pregnant women with a short cervix of 25 mm or less who were between 18 to 22 weeks of pregnancy. The use of cervical pessary (192 women) was associated with a statistically significantly decrease in the incidence of spontaneous preterm birth less than 37 weeks' gestation compared with expectant management (22% versus 59 %; respectively, risk ratio (RR) 0.36, 95% confidence interval (CI) 0.27 to 0.49). Spontaneous preterm birth before 34 weeks was statistically significantly reduced in the pessary group (6% and 27% respectively, RR 0.24; 95% CI 0.13 to 0.43). Mean gestational age at delivery was 37.7 + 2 weeks in the pessary group and 34.9 + 4 weeks in the expectant group. Women in the pessary group used less tocolytics (RR 0.63; 95% CI 0.50 to 0.81) and corticosteroids (RR 0.66; 95% CI 0.54 to 0.81) than the expectant group. Vaginal discharge was more common in the pessary group (RR 2.18; 95% CI 1.87 to 2.54). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Ninety-five per cent of women in the pessary group would recommend this intervention to other people. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group (RR 0.17; 95% CI 0.07 to 0.42).
AUTHORS' CONCLUSIONS
The review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.
Topics: Female; Gestational Age; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic
PubMed: 23728668
DOI: 10.1002/14651858.CD007873.pub3