-
BMJ Open Jul 2022Pelvic organ prolapse (POP) can be effectively managed using a pessary. A scoping review found that pessary self-management appears to benefit women with no increased... (Review)
Review
INTRODUCTION
Pelvic organ prolapse (POP) can be effectively managed using a pessary. A scoping review found that pessary self-management appears to benefit women with no increased risk. Despite this, many are unwilling to self-manage their pessary. At present, there is a lack of understanding about what affects willingness to self-manage a pessary. However, there may be relevant, transferable findings from other literature about barriers to the self-management of other chronic conditions. Therefore, this systematic review aims to identify, appraise and synthesise the findings of published qualitative research exploring the barriers and facilitators to self-management of chronic conditions reported by women.
METHODS AND ANALYSIS
The systematic review will be conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and a guide for the systematic review of qualitative data. A search of MEDLINE, CINAHL, Embase and PsycInfo will be undertaken to identify relevant articles that meet the eligibility criteria using the search terms 'Women', 'Woman' 'Female,' 'Chronic', 'Long-term', 'Disease', 'Illness', 'Condition' 'Health,' 'Self-management,' 'Qualitative,' 'Barrier' and 'Facilitator'. A hand search of the reference list of non-original research identified during the search but excluded will be conducted for additional publications, which meet the inclusion and exclusion criteria. Studies published before 2005 and those not available in English will be excluded. Data relevant to the topic will be extracted and critical appraisal of all included publications undertaken.
ETHICS AND DISSEMINATION
No ethical or Health Research Authority approval is required to undertake the systematic review. The systematic review findings will be disseminated by publication. The findings will also inform subsequent exploratory work regarding pessary self-management.
PROSPERO REGISTRATION NUMBER
CRD42022327643.
Topics: Chronic Disease; Female; Humans; Qualitative Research; Research Design; Self-Management
PubMed: 35858726
DOI: 10.1136/bmjopen-2022-061655 -
Climacteric : the Journal of the... Dec 2022We aimed to systematically review the impact of local estrogen use in combination with a pessary on vaginal complications in postmenopausal women with pelvic organ... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
We aimed to systematically review the impact of local estrogen use in combination with a pessary on vaginal complications in postmenopausal women with pelvic organ prolapse (POP).
METHODS
We searched databases including Medline, Embase, PubMed, Clinical Trials and the Cochrane Central Register of Controlled Trials for relevant literature published in English from inception to 31 May 2021. Only randomized controlled trials (RCTs) and cohort studies were included.
RESULTS
In total, five studies were included (three RCTs, one prospective study and one retrospective cohort study). The meta-analysis was performed with subgroups. Our results indicated a significantly lower incidence of bacterial vaginosis (BV) among postmenopausal women who used estrogen than among controls, with a total pooled odds ratio (OR) of 0.29 (95% confidence interval [CI]: 0.11-0.72; = 38%; = 0.008). The summary ORs of the estrogen use group were 0.98 (95% CI: 0.59-1.63; = 41%; = 0.95) for vaginal ulceration, 0.80 (95% CI: 0.42-1.54; = 29%; = 0.50) for vaginal bleeding and 0.74 (95% CI: 0.35-1.58; = 35%; = 0.44) for vaginal discharge.
CONCLUSIONS
Local estrogen in combination with a pessary could decrease the BV rate among postmenopausal women with POP. However, consensus regarding the value of estrogen use for decreasing other pessary complications has not yet been reached. Additional multicenter RCTs with large sample sizes should be conducted to better understand the effect of estrogen use on reducing pessary-related complications.
Topics: Female; Humans; Pessaries; Pelvic Organ Prolapse; Vagina; Estrogens; Uterine Hemorrhage; Multicenter Studies as Topic
PubMed: 35695119
DOI: 10.1080/13697137.2022.2079973 -
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 -
Reproductive Sciences (Thousand Oaks,... Jan 2023This study was to assess the effectiveness of cervical pessary combined with vaginal progesterone for the prevention of preterm birth (PTB). Ten studies about singleton... (Meta-Analysis)
Meta-Analysis Review
This study was to assess the effectiveness of cervical pessary combined with vaginal progesterone for the prevention of preterm birth (PTB). Ten studies about singleton [five randomized controlled trials (RCTs), vs vaginal progesterone; four cohorts, vs vaginal progesterone; two cohorts, vs cervical cerclage + vaginal progesterone] and two cohort studies about multiple pregnancies (vs vaginal progesterone) were included after searching electronic databases. For singleton pregnancies, the meta-analysis of three non-RCTs [relative risk (RR) = 0.41, p = 0.001] or total trials in non-Asian country (RR = 0.56, p = 0.03) revealed that compared with vaginal progesterone alone, cervical pessary + vaginal progesterone treatment had significant effectiveness on preventing PTB < 34 weeks, but not for five RCTs; meta-analysis of two trials showed that cervical pessary + vaginal progesterone had no significant prevention effects of PTB compared with cervical cerclage + vaginal progesterone. For multiple pregnancies, meta-analysis of two trials showed that compared with vaginal progesterone, cervical pessary + vaginal progesterone treatment increased neonatal birth weight (standardized mean difference = 0.50, p = 0.01). Trial sequential analysis implied additional studies were required. Four studies vs other controls (pessary, three-combined, tocolysis, conservative or no treatment; one study, each) were selected for systematic review. In conclusion, cervical pessary combined with vaginal progesterone may be safe and effective to prevent PTB in singleton pregnancies and increase neonatal birth weight in the multiple pregnancies compared with vaginal progesterone alone.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Progesterone; Premature Birth; Pessaries; Birth Weight; Cervix Uteri; Administration, Intravaginal
PubMed: 35352330
DOI: 10.1007/s43032-022-00926-x -
BMJ (Clinical Research Ed.) Feb 2022To compare the efficacy of bed rest, cervical cerclage (McDonald, Shirodkar, or unspecified type of cerclage), cervical pessary, fish oils or omega fatty acids,... (Comparative Study)
Comparative Study
OBJECTIVES
To compare the efficacy of bed rest, cervical cerclage (McDonald, Shirodkar, or unspecified type of cerclage), cervical pessary, fish oils or omega fatty acids, nutritional supplements (zinc), progesterone (intramuscular, oral, or vaginal), prophylactic antibiotics, prophylactic tocolytics, combinations of interventions, placebo or no treatment (control) to prevent spontaneous preterm birth in women with a singleton pregnancy and a history of spontaneous preterm birth or short cervical length.
DESIGN
Systematic review with bayesian network meta-analysis.
DATA SOURCES
The Cochrane Pregnancy and Childbirth Group's Database of Trials, the Cochrane Central Register of Controlled Trials, Medline, Embase, CINAHL, relevant journals, conference proceedings, and registries of ongoing trials.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised controlled trials of pregnant women who are at high risk of spontaneous preterm birth because of a history of spontaneous preterm birth or short cervical length. No language or date restrictions were applied.
OUTCOMES
Seven maternal outcomes and 11 fetal outcomes were analysed in line with published core outcomes for preterm birth research. Relative treatment effects (odds ratios and 95% credible intervals) and certainty of evidence are presented for outcomes of preterm birth <34 weeks and perinatal death.
RESULTS
Sixty one trials (17 273 pregnant women) contributed data for the analysis of at least one outcome. For preterm birth <34 weeks (40 trials, 13 310 pregnant women) and with placebo or no treatment as the comparator, vaginal progesterone was associated with fewer women with preterm birth <34 weeks (odds ratio 0.50, 95% credible interval 0.34 to 0.70, high certainty of evidence). Shirodkar cerclage showed the largest effect size (0.06, 0.00 to 0.84), but the certainty of evidence was low. 17OHPC (17α-hydroxyprogesterone caproate; 0.68, 0.43 to 1.02, moderate certainty), vaginal pessary (0.65, 0.39 to 1.08, moderate certainty), and fish oil or omega 3 (0.30, 0.06 to 1.23, moderate certainty) might also reduce preterm birth <34 weeks compared with placebo or no treatment. For the fetal outcome of perinatal death (30 trials, 12 119 pregnant women) and with placebo or no treatment as the comparator, vaginal progesterone was the only treatment that showed clear evidence of benefit for this outcome (0.66, 0.44 to 0.97, moderate certainty). 17OHPC (0.78, 0.50 to 1.21, moderate certainty), McDonald cerclage (0.59, 0.33 to 1.03, moderate certainty), and unspecified cerclage (0.77, 0.53 to 1.11, moderate certainty) might reduce perinatal death rates, but credible intervals could not exclude the possibility of harm. Only progesterone treatments are associated with reduction in neonatal respiratory distress syndrome, neonatal sepsis, necrotising enterocolitis, and admission to neonatal intensive care unit compared with controls.
CONCLUSION
Vaginal progesterone should be considered the preventative treatment of choice for women with singleton pregnancy identified to be at risk of spontaneous preterm birth because of a history of spontaneous preterm birth or short cervical length. Future randomised controlled trials should use vaginal progesterone as a comparator to identify better treatments or combination treatments.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42020169006.
Topics: Administration, Intravaginal; Bayes Theorem; Female; Humans; Network Meta-Analysis; Pregnancy; Premature Birth; Progesterone; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35168930
DOI: 10.1136/bmj-2021-064547 -
International Urogynecology Journal Jul 2022To clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up.
METHODS
Embase, PubMed and Cochrane CENTRAL library were searched in May 2020. Inclusion criteria were: (1) pessary fitting attempted in women with symptomatic POP; (2) pessary fitting success among the study outcomes with a maximal follow-up of 3 months; (3) baseline parameters compared between successful and unsuccessful group. A meta-analysis was performed using the random effects model.
MAIN RESULTS
Twenty-four studies were included in the meta-analysis. Parameters associated with unsuccessful pessary fitting were: age (OR 0.70, 95% CI 0.56-0.86); BMI (OR 1.35, 95% CI 1.08-1.70); menopause (OR 0.65 95% CI 0.47-0.88); de novo stress urinary incontinence (OR 5.59, 95% CI 2.24-13.99); prior surgery, i.e. hysterectomy (OR 1.88, 95% CI 1.48-2.40), POP surgery (OR 2.13, 95% CI 1.34-3.38), pelvic surgery (OR 1.81, 05% CI 1.01-3.26) and incontinence surgery (OR 1.87, 95% CI 1.08-3.25); Colorectal-Anal Distress Inventory-8 scores (OR 1.92, 95% CI 1.22-3.02); solitary predominant posterior compartment POP (OR 1.59, 95% CI 1.08-2.35); total vaginal length (OR 0.56, 95% CI 0.32-0.97); wide introitus (OR 4.85, 95% CI 1.60-14.68); levator ani avulsion (OR 2.47, 95% CI 1.35-4.53) and hiatal area on maximum Valsalva (OR 1.89, 95% CI 1.27-2.80).
CONCLUSION
During counselling for pessary treatment a higher risk of failure due to the aforementioned parameters should be discussed and modifiable parameters should be addressed. More research is needed on the association between anatomical parameters and specific reasons for unsuccessful pessary fitting.
Topics: Female; Humans; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Urinary Incontinence, Stress; Vagina
PubMed: 35037973
DOI: 10.1007/s00192-021-05015-2 -
International Urogynecology Journal Feb 2022Pelvic organ prolapse (POP) is common and associated with sexual dysfunction. Vaginal pessaries are an effective treatment for POP, but their impact on sexual function... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION AND HYPOTHESIS
Pelvic organ prolapse (POP) is common and associated with sexual dysfunction. Vaginal pessaries are an effective treatment for POP, but their impact on sexual function is not well established. The aim of this systematic review and meta-analysis was to establish the impact of vaginal pessaries used for POP on female sexual function.
METHODS
Systematic review of the literature following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and checklist. A comprehensive search was conducted across Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, EMBASE, MEDLINE, CINAHL, ClinicalTrials.gov , The WHO International Clinical Trials Registry Platform, ProQuest Dissertations & Theses, Open Grey and Scopus Citation Database. Randomised controlled trials and cohort studies that assessed sexual function in women pre- and post-pessary treatment for POP were included, assessed for risk of bias and their results synthesised.
RESULTS
A total of 1,945 titles and abstracts were screened, 104 full-text articles were assessed for eligibility, 14 studies were included in the narrative analysis and 7 studies were included in the meta-analysis. The results suggest that, in sexually active women, there is no evidence of a deterioration in sexual function and some evidence of an improvement.
DISCUSSION
This review offers reassurance that in sexually active women who successfully use a pessary for treatment of their prolapse, there is no deterioration in sexual function. There is some evidence of an improvement in sexual function, but given the clinical heterogeneity in the studies included, caution should be taken in generalising these findings.
Topics: Female; Humans; Pelvic Organ Prolapse; Pessaries; Sexual Dysfunction, Physiological; Treatment Outcome
PubMed: 34982188
DOI: 10.1007/s00192-021-05059-4 -
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 -
Neurourology and Urodynamics Aug 2021To systematically evaluate the content and quality of national and international clinical guidelines on pelvic organ prolapse (POP).
AIMS
To systematically evaluate the content and quality of national and international clinical guidelines on pelvic organ prolapse (POP).
METHODS
We searched medical databases and organizations websites, to identify national and international guidelines on diagnosis and management of POP. Five authors independently assessed guidelines using the validated AGREE II tool. Its six domains include (1) scope and purpose, (2) stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability, and (6) editorial independence.
RESULTS
Eight guidelines met the inclusion criteria. Three hundred and thirteen different recommendations were identified. One hundred and ninety-nine recommendations were comparable across guidelines. Thirty-one recommendations were not supported by research evidence. Assessment by history and physical examination using the POP quantification system and consideration of imaging were recommendations featuring in all guidelines. Conservative treatment recommendations namely pelvic floor muscle training and vaginal pessaries were also found in all guidelines. Regarding surgical management, patient counseling, treating only symptomatic POP, consideration of apical fixation during surgical treatment, and use of biological or synthetic implants in recurrent cases were recommendations in all guidelines. Overall, the highest median scores were in the domains "scope and purpose" and "rigor of development". The lowest median score was for applicability (28.3%). Although the median score of "editorial independence" was high (85.4%), variability was also substantial (interquartile range: 12.5-100).
CONCLUSION
We identified variations in quality and deficiencies in certain areas, especially "applicability" and "editorial independence." Improvements in these key domains may enhance the quality and clinical impact of clinical practice guidelines.
Topics: Female; Humans; Databases, Factual; Pelvic Organ Prolapse; Practice Guidelines as Topic
PubMed: 34350610
DOI: 10.1002/nau.24709 -
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