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American Journal of Obstetrics and... Jul 2020Randomized controlled trials that have assessed the efficacy of cervical pessary to prevent preterm birth in asymptomatic high-risk women have reported conflicting... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Randomized controlled trials that have assessed the efficacy of cervical pessary to prevent preterm birth in asymptomatic high-risk women have reported conflicting results.
OBJECTIVE
To evaluate the efficacy and safety of cervical pessary to prevent preterm birth and adverse perinatal outcomes in asymptomatic high-risk women.
DATA SOURCES
MEDLINE, EMBASE, POPLINE, CINAHL, and LILACS (from their inception to October 31, 2019), Cochrane databases, Google Scholar, bibliographies, and conference proceedings.
STUDY ELIGIBILITY CRITERIA
Randomized controlled trials that compared cervical pessary with standard care (no pessary) or alternative interventions in asymptomatic women at high risk for preterm birth.
STUDY APPRAISAL AND SYNTHESIS METHODS
The systematic review was conducted according to the Cochrane Handbook guidelines. The primary outcome was spontaneous preterm birth <34 weeks of gestation. Secondary outcomes included adverse pregnancy, maternal, and perinatal outcomes. Pooled relative risks with 95% confidence intervals were calculated. Quality of evidence was assessed using the GRADE methodology.
RESULTS
Twelve studies (4687 women and 7167 fetuses/infants) met the inclusion criteria: 8 evaluated pessary vs no pessary in women with a short cervix, 2 assessed pessary vs no pessary in unselected multiple gestations, and 2 compared pessary vs vaginal progesterone in women with a short cervix. There were no significant differences between the pessary and no pessary groups in the risk of spontaneous preterm birth <34 weeks of gestation among singleton gestations with a cervical length ≤25 mm (relative risk, 0.80; 95% confidence interval, 0.43-1.49; 6 trials, 1982 women; low-quality evidence), unselected twin gestations (relative risk, 1.05; 95% confidence interval, 0.79-1.41; 1 trial, 1177 women; moderate-quality evidence), twin gestations with a cervical length <38 mm (relative risk, 0.75; 95% confidence interval, 0.41-1.36; 3 trials, 1128 women; low-quality evidence), and twin gestations with a cervical length ≤25 mm (relative risk; 0.72, 95% confidence interval, 0.25-2.06; 2 trials, 348 women; low-quality evidence). Overall, no significant differences were observed between the pessary and no pessary groups in preterm birth <37, <32, and <28 weeks of gestation, and most adverse pregnancy, maternal, and perinatal outcomes (low- to moderate-quality evidence for most outcomes). There were no significant differences in the risk of spontaneous preterm birth <34 weeks of gestation between pessary and vaginal progesterone in singleton gestations with a cervical length ≤25 mm (relative risk, 0.99; 95% confidence interval, 0.54-1.83; 1 trial, 246 women; low-quality evidence) and twin gestations with a cervical length <38 mm (relative risk, 0.73; 95% confidence interval, 0.46-1.18; 1 trial, 297 women; very low-quality evidence). Vaginal discharge was significantly more frequent in the pessary group than in the no pessary and vaginal progesterone groups (relative risks, ∼2.20; high-quality evidence).
CONCLUSION
Current evidence does not support the use of cervical pessary to prevent preterm birth or to improve perinatal outcomes in singleton or twin gestations with a short cervix and in unselected twin gestations.
Topics: Asymptomatic Diseases; Cervix Uteri; Female; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Risk Assessment
PubMed: 32027880
DOI: 10.1016/j.ajog.2019.12.266 -
Arab Journal of Urology Mar 2019: To review lower urinary tract symptoms (LUTS), which include a large variety of bladder complaints, in women with simultaneous pelvic organ prolapse (POP). : This... (Review)
Review
: To review lower urinary tract symptoms (LUTS), which include a large variety of bladder complaints, in women with simultaneous pelvic organ prolapse (POP). : This article is a systematic review of the current literature on LUTS occurring simultaneously with POP following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. : The prevalence of both conditions is high, but they occur more frequently together than can be explained by chance. It appears that POP is in some women causative of overactive bladder (OAB) symptoms, as in many women correction of the POP resolves the bladder symptoms and small studies of women with detrusor underactivity also demonstrate resolution of symptoms. The most plausible explanation for the relationship is that POP causes bladder outlet obstruction, which results in excess bladder irritability or poor contractility. However, not all women have resolution of their OAB symptoms and some women develop them after POP repair, so this explanation requires more in depth study. : Women with both LUTS and symptomatic POP should probably have their POP targeted, as its reduction either via surgery or pessary can correct the LUTS. However, no studies have addressed asymptomatic POP, so it is unclear if treating POP in these instances is of benefit. BOO: bladder outlet obstruction; DO: detrusor overactivity; DU: detrusor underactivity; OAB: overactive bladder; PQ: detrusor pressure at maximum urinary flow; POP: pelvic organ prolapse; PVR: post-void residual urine volume; RR: relative risk; SUFU: Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction; UDS: urodynamic studies; (S)(U)UI: (stress) (urgency) urinary incontinence.
PubMed: 33110659
DOI: 10.1080/2090598X.2019.1589929 -
Interventions during pregnancy to prevent preterm birth: an overview of Cochrane systematic reviews.The Cochrane Database of Systematic... Nov 2018Preterm birth (PTB) is a major factor contributing to global rates of neonatal death and to longer-term health problems for surviving infants. Both the World Health... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Preterm birth (PTB) is a major factor contributing to global rates of neonatal death and to longer-term health problems for surviving infants. Both the World Health Organization and the United Nations consider prevention of PTB as central to improving health care for pregnant women and newborn babies. Current preventative clinical strategies show varied efficacy in different populations of pregnant women, frustrating women and health providers alike, while researchers call for better understanding of the underlying mechanisms that lead to PTB.
OBJECTIVES
We aimed to summarise all evidence for interventions relevant to the prevention of PTB as reported in Cochrane systematic reviews (SRs). We intended to highlight promising interventions and to identify SRs in need of an update.
METHODS
We searched the Cochrane Database of Systematic Reviews (2 November 2017) with key words to capture any Cochrane SR that prespecified or reported a PTB outcome. Inclusion criteria focused on pregnant women without signs of preterm labour or ruptured amniotic membranes. We included reviews of interventions for pregnant women irrespective of their risk status. We followed standard Cochrane methods.We applied GRADE criteria to evaluate the quality of SR evidence. We assigned graphic icons to classify the effectiveness of interventions as: clear evidence of benefit; clear evidence of harm; clear evidence of no effect or equivalence; possible benefit; possible harm; or unknown benefit or harm. We defined clear evidence of benefit and clear evidence of harm to be GRADE moderate- or high-quality evidence with a confidence interval (CI) that does not cross the line of no effect. Clear evidence of no effect or equivalence is GRADE moderate- or high-quality evidence with a narrow CI crossing the line of no effect. Possible benefit and possible harm refer to GRADE low-quality evidence with a clear effect (CI does not cross the line of no effect) or GRADE moderate- or high-quality evidence with a wide CI. Unknown harm or benefit refers to GRADE low- or very low-quality evidence with a wide CI.
MAIN RESULTS
We included 83 SRs; 70 had outcome data. Below we highlight key results from a subset of 36 SRs of interventions intended to prevent PTB.
OUTCOME
preterm birthClear evidence of benefitFour SRs reported clear evidence of benefit to prevent specific populations of pregnant women from giving birth early, including midwife-led continuity models of care versus other models of care for all women; screening for lower genital tract infections for pregnant women less than 37 weeks' gestation and without signs of labour, bleeding or infection; and zinc supplementation for pregnant women without systemic illness. Cervical cerclage showed clear benefit for women with singleton pregnancy and high risk of PTB only.Clear evidence of harmNo included SR reported clear evidence of harm.No effect or equivalenceFor pregnant women at high risk of PTB, bedrest for women with singleton pregnancy and antibiotic prophylaxis during the second and third trimester were of no effect or equivalent to a comparator.Possible benefitFour SRs found possible benefit in: group antenatal care for all pregnant women; antibiotics for pregnant women with asymptomatic bacteriuria; pharmacological interventions for smoking cessation for pregnant women who smoke; and vitamin D supplements alone for women without pre-existing conditions such as diabetes.Possible harmOne SR reported possible harm (increased risk of PTB) with intramuscular progesterone, but this finding is only relevant to women with multiple pregnancy and high risk of PTB. Another review found possible harm with vitamin D, calcium and other minerals for pregnant women without pre-existing conditions.
OUTCOME
perinatal deathClear evidence of benefitTwo SRs reported clear evidence of benefit to reduce pregnant women's risk of perinatal death: midwife-led continuity models of care for all pregnant women; and fetal and umbilical Doppler for high-risk pregnant women.Clear evidence of harmNo included SR reported clear evidence of harm.No effect or equivalenceFor pregnant women at high risk of PTB, antibiotic prophylaxis during the second and third trimester was of no effect or equivalent to a comparator.Possible benefitOne SR reported possible benefit with cervical cerclage for women with singleton pregnancy and high risk of PTB.Possible harmOne SR reported possible harm associated with a reduced schedule of antenatal visits for pregnant women at low risk of pregnancy complications; importantly, these women already received antenatal care in settings with limited resources.
OUTCOMES
preterm birth and perinatal deathUnknown benefit or harmFor pregnant women at high risk of PTB for any reason including multiple pregnancy, home uterine monitoring was of unknown benefit or harm. For pregnant women at high risk due to multiple pregnancy: bedrest, prophylactic oral betamimetics, vaginal progesterone and cervical cerclage were all of unknown benefit or harm.
AUTHORS' CONCLUSIONS
Implications for practiceThe overview serves as a map and guide to all current evidence relevant to PTB prevention published in the Cochrane Library. Of 70 SRs with outcome data, we identified 36 reviews of interventions with the aim of preventing PTB. Just four of these SRs had evidence of clear benefit to women, with an additional four SRs reporting possible benefit. No SR reported clear harm, which is an important finding for women and health providers alike.The overview summarises no evidence for the clinically important interventions of cervical pessary, cervical length assessment and vaginal progesterone because these Cochrane Reviews were not current. These are active areas for PTB research.The graphic icons we assigned to SR effect estimates do not constitute clinical guidance or an endorsement of specific interventions for pregnant women. It remains critical for pregnant women and their healthcare providers to carefully consider whether specific strategies to prevent PTB will be of benefit for individual women, or for specific populations of women.Implications for researchFormal consensus work is needed to establish standard language for overviews of reviews and to define the limits of their interpretation.Clinicians, researchers and funders must address the lack of evidence for interventions relevant to women at high risk of PTB due to multiple pregnancy.
Topics: Anti-Bacterial Agents; Bed Rest; Female; Humans; Pregnancy; Premature Birth; Smoking Cessation; Systematic Reviews as Topic; Vitamin D; Vitamins
PubMed: 30480756
DOI: 10.1002/14651858.CD012505.pub2 -
The Cochrane Database of Systematic... Aug 2018Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately.
OBJECTIVES
The aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ prolapse.
SEARCH METHODS
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, handsearching of journals and conference proceedings (searched 30 November 2017), and reference lists of relevant articles. We also contacted researchers in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. Our primary outcomes were objective failure at any site and subjective postoperative prolapse symptoms. We also measured adverse effects, focusing on intraoperative blood loss and blood transfusion, intraoperative ureteral injury, and postoperative urinary tract infection.
MAIN RESULTS
We included 15 RCTs that compared eight different interventions versus no treatment for 1992 women in five countries. Most interventions were assessed by only one RCT with evidence quality ranging from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.Pelvic floor muscle training (PFMT) compared with no treatment (three RCTs) - peri-operative intervention The simplest of the PFMT programmes required women to attend six perioperative consultations in the three months surrounding prolapse surgery. Trial results provided no clear evidence of a difference between groups in objective failure at any site at 12 to 24 months (odds ratio (OR) 0.93, 95% confidence interval (CI) 0.56 to 1.54; two RCTs, 327 women; moderate-quality evidence). With respect to awareness of prolapse, findings were inconsistent. One RCT found no evidence of a difference between groups at 24 months (OR 1.07, 95% CI 0.61 to 1.87; one RCT, 305 women; low-quality evidence), and a second small RCT reported symptom reduction from the Pelvic Organ Prolapse Symptom Questionnaire completed by the intervention group at 12 months (mean difference (MD) -3.90, 95% CI -6.11 to -1.69; one RCT, 27 women; low-quality evidence). Researchers found no clear differences between groups at 24-month follow-up in rates of repeat surgery (or pessary) for prolapse (OR 1.92, 95% CI 0.74 to 5.02; one RCT, 316 women; low-quality evidence).Other interventionsSingle RCTs evaluated the following interventions: preoperative guided imagery (N = 44); injection of vasoconstrictor agent at commencement of vaginal prolapse surgery (N = 76); ureteral stent placement during uterosacral ligament suspension (N = 91); vaginal pack (N = 116); prophylactic antibiotics for women requiring postoperative urinary catheterisation (N = 159); and postoperative vaginal dilators (N = 60).Two RCTs evaluated bowel preparation (N = 298), and four RCTs assessed the method and timing of postoperative catheterisation (N = 514) - all in different comparisons.None of these studies reported our primary review outcomes. One study reported intraoperative blood loss and suggested that vaginal injection of vasoconstrictors at commencement of surgery may reduce blood loss by a mean of about 30 mL. Another study reported intraoperative ureteral injury and found no clear evidence that ureteral stent placement reduces ureteral injury. Three RCTs reported postoperative urinary tract infection and found no conclusive evidence that rates of urinary tract infection were influenced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators. Other studies did not report these outcomes.
AUTHORS' CONCLUSIONS
There was a paucity of data about perioperative interventions in pelvic organ prolapse surgery. A structured programme of pelvic floor muscle training before and after prolapse surgery did not consistently demonstrate any benefit for the intervention; however, this finding is based on the results of two small studies. With regard to other interventions (preoperative bowel preparation and injection of vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, postoperative vaginal pack insertion, use of vaginal dilators, prophylactic antibiotics for postoperative catheter care), we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinically meaningful reductions in adverse effects, such as intraoperative or postoperative blood transfusion, intraoperative ureteral injury, or postoperative urinary tract infection.
Topics: Antibiotic Prophylaxis; Exercise; Female; Humans; Imagery, Psychotherapy; Pelvic Floor; Pelvic Organ Prolapse; Perioperative Care; Pessaries; Randomized Controlled Trials as Topic; Recurrence; Reoperation; Stents; Vasoconstrictor Agents
PubMed: 30121957
DOI: 10.1002/14651858.CD013105 -
The Cochrane Database of Systematic... Mar 2018Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed defecation and sexual dysfunction. Interventions for prevention and conservative management include lifestyle measures, pelvic floor muscle training, and pessary use. We conducted this review to assess the surgical management of posterior vaginal wall prolapse.
OBJECTIVES
To evaluate the safety and effectiveness of any surgical intervention compared with another surgical intervention for management of posterior vaginal wall prolapse.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (searched April 2017). We also searched the reference lists of relevant articles, and we contacted researchers in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing different types of surgery for posterior vaginal wall prolapse.
DATA COLLECTION AND ANALYSIS
We used Cochrane methods. Our primary outcomes were subjective awareness of prolapse, repeat surgery for any prolapse, and objectively determined recurrent posterior wall prolapse.
MAIN RESULTS
We identified 10 RCTs evaluating 1099 women. Evidence quality ranged from very low to moderate. The main limitations of evidence quality were risk of bias (associated mainly with performance, detection, and attrition biases) and imprecision (associated with small overall sample sizes and low event rates).Transanal repair versus transvaginal repair (four RCTs; n = 191; six months' to four years' follow-up)Awareness of prolapse is probably more common after the transanal approach (risk ratio (RR) 2.78, 95% confidence interval (CI) 1.00 to 7.70; 2 RCTs; n = 87; I = 0%; low-quality evidence). If 10% of women are aware of prolapse after transvaginal repair, between 10% and 79% are likely to be aware after transanal repair.Repeat surgery for any prolapse: Evidence is insufficient to show whether there were any differences between groups (RR 2.42, 95% CI 0.75 to 7.88; 1 RCT; n = 57; low-quality evidence).Recurrent posterior vaginal wall prolapse is probably more likely after transanal repair (RR 4.12, 95% CI 1.56 to 10.88; 2 RCTs; n = 87; I = 35%; moderate-quality evidence). If 10% of women have recurrent prolapse on examination after transvaginal repair, between 16% and 100% are likely to have recurrent prolapse after transanal repair.Postoperative obstructed defecation is probably more likely with transanal repair (RR 1.67, 95% CI 1.00 to 2.79; 3 RCTs; n = 113; I = 10%; low-quality evidence).Postoperative dyspareunia: Evidence is insufficient to show whether there were any differences between groups (RR 0.32, 95% CI 0.09 to 1.15; 2 RCTs; n = 80; I = 5%; moderate-quality evidence).Postoperative complications: Trials have provided no conclusive evidence of any differences between groups (RR 3.57, 95% CI 0.94 to 13.54; 3 RCTs; n = 135; I = 37%; low-quality evidence). If 2% of women have complications after transvaginal repair, then between 2% and 21% are likely to have complications after transanal repair.Evidence shows no clear differences between groups in operating time (in minutes) (mean difference (MD) 1.49, 95% CI -11.83 to 8.84; 3 RCTs; n = 137; I = 90%; very low-quality evidence).Biological graft versus native tissue repairEvidence is insufficient to show whether there were any differences between groups in rates of awareness of prolapse (RR 1.09, 95% CI 0.45 to 2.62; 2 RCTs; n = 181; I = 13%; moderate-quality evidence) or repeat surgery for any prolapse (RR 0.60, 95% CI 0.18 to 1.97; 2 RCTs; n = 271; I = 0%; moderate-quality evidence). Trials have provided no conclusive evidence of a difference in rates of recurrent posterior vaginal wall prolapse (RR 0.55, 95% CI 0.30 to 1.01; 3 RCTs; n = 377; I = 6%; moderate-quality evidence); if 13% of women have recurrent prolapse on examination after native tissue repair, between 4% and 13% are likely to have recurrent prolapse after biological graft. Evidence is insufficient to show whether there were any differences between groups in rates of postoperative obstructed defecation (RR 0.96, 95% CI 0.50 to 1.86; 2 RCTs; n = 172; I = 42%; moderate-quality evidence) or postoperative dyspareunia (RR 1.27, 95% CI 0.26 to 6.25; 2 RCTs; n = 152; I = 74%; low-quality evidence). Postoperative complications were more common with biological repair (RR 1.82, 95% CI 1.22 to 2.72; 3 RCTs; n = 448; I = 0%; low-quality evidence).Other comparisonsSingle RCTs compared site-specific vaginal repair versus midline fascial plication (n = 74), absorbable graft versus native tissue repair (n = 132), synthetic graft versus native tissue repair (n = 191), and levator ani plication versus midline fascial plication (n = 52). Data were scanty, and evidence was insufficient to show any conclusions about the relative effectiveness or safety of any of these interventions. The mesh exposure rate in the synthetic group compared with the native tissue group was 7%.
AUTHORS' CONCLUSIONS
Transvaginal repair may be more effective than transanal repair for posterior wall prolapse in preventing recurrence of prolapse, in the light of both objective and subjective measures. However, data on adverse effects were scanty. Evidence was insufficient to permit any conclusions about the relative effectiveness or safety of other types of surgery. Evidence does not support the utilisation of any mesh or graft materials at the time of posterior vaginal repair. Withdrawal of some commercial transvaginal mesh kits from the market may limit the generalisability of our findings.
Topics: Awareness; Dyspareunia; Female; Gynecologic Surgical Procedures; Humans; Pelvic Organ Prolapse; Postoperative Complications; Randomized Controlled Trials as Topic; Recurrence; Reoperation; Surgical Mesh; Urinary Incontinence, Stress; Uterine Prolapse
PubMed: 29502352
DOI: 10.1002/14651858.CD012975 -
The Cochrane Database of Systematic... Jun 2017Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is... (Review)
Review
BACKGROUND
Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013.
OBJECTIVES
To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy.
MAIN RESULTS
Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.
AUTHORS' CONCLUSIONS
RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.
Topics: Dinoprostone; Early Termination of Clinical Trials; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Uterine Rupture; Vaginal Birth after Cesarean
PubMed: 28599068
DOI: 10.1002/14651858.CD009792.pub3 -
The Cochrane Database of Systematic... Aug 2016Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring). This is an update of a Chochrane systematic review; the original version was first published in October 2006.
OBJECTIVES
The objective of this review was to compare the efficacy and safety of intra-vaginal oestrogenic preparations in relieving the symptoms of vaginal atrophy in postmenopausal women.
SEARCH METHODS
We searched the following databases and trials registers to April 2016: Cochrane Gynaecology and Fertility Group Register of trials, The Cochrane Central Register of Controlled Trials (CENTRAL; 2016 issue 4), MEDLINE, Embase, PsycINFO, DARE, the Web of Knowledge, OpenGrey, LILACS, PubMed and reference lists of articles. We also contacted experts and researchers in the field.
SELECTION CRITERIA
The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for at least 12 weeks for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial eligibility and risk of bias and extracted the data. The primary review outcomes were improvement in symptoms (participant-assessed), and the adverse event endometrial thickness. Secondary outcomes were improvement in symptoms (clinician-assessed), other adverse events (breast disorders e.g. breast pain, enlargement or engorgement, total adverse events, excluding breast disorders) and adherence to treatment. We combined data to calculate pooled risk ratios (RRs) (dichotomous outcomes) and mean differences (MDs) (continuous outcomes) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I(2) statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.
MAIN RESULTS
We included 30 RCTs (6235 women) comparing different intra-vaginal oestrogenic preparations with each other and with placebo. The evidence was low to moderate quality; limitations were poor reporting of study methods and serious imprecision (effect estimates with wide confidence intervals)1. Oestrogen ring versus other regimensOther regimens included oestrogen cream, oestrogen tablets and placebo. There was no evidence of a difference in improvement in symptoms (participant assessment) either between oestrogen ring and oestrogen cream (odds ratio (OR) 1.33, 95% CI 0.80 to 2.19, two RCTs, n = 341, I(2) = 0%, low-quality evidence) or between oestrogen ring and oestrogen tablets (OR 0.78, 95% CI 0.53 to 1.15, three RCTs, n = 567, I(2) = 0%, low-quality evidence). However, a higher proportion of women reported improvement in symptoms following treatment with oestrogen ring compared with placebo (OR 12.67, 95% CI 3.23 to 49.66, one RCT, n = 67). With respect to endometrial thickness, a higher proportion of women who received oestrogen cream showed evidence of increase in endometrial thickness compared to those who were treated with oestrogen ring (OR 0.36, 95% CI 0.14 to 0.94, two RCTs, n = 273; I(2) = 0%, low-quality evidence). This may have been due to the higher doses of cream used. 2. Oestrogen tablets versus other regimensOther regimens in this comparison included oestrogen cream, and placebo. There was no evidence of a difference in the proportions of women who reported improvement in symptoms between oestrogen tablets and oestrogen cream (OR 1.06, 95% CI 0.55 to 2.01, two RCTs, n = 208, I(2) = 0% low-quality evidence). A higher proportion of women who were treated with oestrogen tablets reported improvement in symptoms compared to those who received placebo using a fixed-effect model (OR 12.47, 95% CI 9.81 to 15.84, two RCTs, n = 1638, I(2) = 83%, low-quality evidence); however, using a random-effect model did not demonstrate any evidence of a difference in the proportions of women who reported improvement between the two treatment groups (OR 5.80, 95% CI 0.88 to 38.29). There was no evidence of a difference in the proportions of women with increase in endometrial thickness between oestrogen tablets and oestrogen cream (OR 0.31, 95% CI 0.06 to 1.60, two RCTs, n = 151, I(2) = 0%, low-quality evidence).3. Oestrogen cream versus other regimensOther regimens identified in this comparison included isoflavone gel and placebo. There was no evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and isoflavone gel (OR 2.08, 95% CI 0.08 to 53.76, one RCT, n = 50, low-quality evidence). However, there was evidence of a difference in the proportions of women with improvement in symptoms between oestrogen cream and placebo with more women who received oestrogen cream reporting improvement in symptoms compared to those who were treated with placebo (OR 4.10, 95% CI 1.88 to 8.93, two RCTs, n = 198, I(2) = 50%, low-quality evidence). None of the included studies in this comparison reported data on endometrial thickness.
AUTHORS' CONCLUSIONS
There was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other. However, there was low-quality evidence that intra-vaginal oestrogenic preparations improve the symptoms of vaginal atrophy in postmenopausal women when compared to placebo. There was low-quality evidence that oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring; this may have been due to the higher doses of cream used. However there was no evidence of a difference in the overall body of evidence in adverse events between the various oestrogenic preparations compared with each other or with placebo.
Topics: Administration, Intravaginal; Aged; Atrophy; Estradiol; Estrogens; Female; Humans; Hydrogen-Ion Concentration; Isoflavones; Middle Aged; Postmenopause; Randomized Controlled Trials as Topic; Tablets; Vagina; Vaginal Creams, Foams, and Jellies; Vaginitis
PubMed: 27577677
DOI: 10.1002/14651858.CD001500.pub3 -
The Cochrane Database of Systematic... Nov 2015Pelvic floor muscle training (PFMT) is a first-line conservative treatment for urinary incontinence in women. Other active treatments include: physical therapies (e.g.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pelvic floor muscle training (PFMT) is a first-line conservative treatment for urinary incontinence in women. Other active treatments include: physical therapies (e.g. vaginal cones); behavioural therapies (e.g. bladder training); electrical or magnetic stimulation; mechanical devices (e.g. continence pessaries); drug therapies (e.g. anticholinergics (solifenacin, oxybutynin, etc.) and duloxetine); and surgical interventions including sling procedures and colposuspension. This systematic review evaluated the effects of adding PFMT to any other active treatment for urinary incontinence in women
OBJECTIVES
To compare the effects of pelvic floor muscle training combined with another active treatment versus the same active treatment alone in the management of women with urinary incontinence.
SEARCH METHODS
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 5 May 2015), and CINAHL (January 1982 to 6 May 2015), and the reference lists of relevant articles.
SELECTION CRITERIA
We included randomised or quasi-randomised trials with two or more arms, of women with clinical or urodynamic evidence of stress urinary incontinence, urgency urinary incontinence or mixed urinary incontinence. One arm of the trial included PFMT added to another active treatment; the other arm included the same active treatment alone.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for eligibility and methodological quality and resolved any disagreement by discussion or consultation with a third party. We extracted and processed data in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. Other potential sources of bias we incorporated into the 'Risk of bias' tables were ethical approval, conflict of interest and funding source.
MAIN RESULTS
Thirteen trials met the inclusion criteria, comprising women with stress urinary incontinence (SUI), urgency urinary incontinence (UUI) or mixed urinary incontinence (MUI); they compared PFMT added to another active treatment (585 women) with the same active treatment alone (579 women). The pre-specified comparisons were reported by single trials, except bladder training, which was reported by two trials, and electrical stimulation, which was reported by three trials. However, only two of the three trials reporting electrical stimulation could be pooled, as one of the trials did not report any relevant data. We considered the included trials to be at unclear risk of bias for most of the domains, predominantly due to the lack of adequate information in a number of trials. This affected our rating of the quality of evidence. The majority of the trials did not report the primary outcomes specified in the review (cure or improvement, quality of life) or measured the outcomes in different ways. Effect estimates from small, single trials across a number of comparisons were indeterminate for key outcomes relating to symptoms, and we rated the quality of evidence, using the GRADE approach, as either low or very low. More women reported cure or improvement of incontinence in two trials comparing PFMT added to electrical stimulation to electrical stimulation alone, in women with SUI, but this was not statistically significant (9/26 (35%) versus 5/30 (17%); risk ratio (RR) 2.06, 95% confidence interval (CI) 0.79 to 5.38). We judged the quality of the evidence to be very low. There was moderate-quality evidence from a single trial investigating women with SUI, UUI or MUI that a higher proportion of women who received a combination of PFMT and heat and steam generating sheet reported a cure compared to those who received the sheet alone: 19/37 (51%) versus 8/37 (22%) with a RR of 2.38, 95% CI 1.19 to 4.73). More women reported cure or improvement of incontinence in another trial comparing PFMT added to vaginal cones to vaginal cones alone, but this was not statistically significant (14/15 (93%) versus 14/19 (75%); RR 1.27, 95% CI 0.94 to 1.71). We judged the quality of the evidence to be very low. Only one trial evaluating PFMT when added to drug therapy provided information about adverse events (RR 0.84, 95% CI 0.45 to 1.60; very low-quality evidence).With regard to condition-specific quality of life, there were no statistically significant differences between women (with SUI, UUI or MUI) who received PFMT added to bladder training and those who received bladder training alone at three months after treatment, on either the Incontinence Impact Questionnaire-Revised scale (mean difference (MD) -5.90, 95% CI -35.53 to 23.73) or on the Urogenital Distress Inventory scale (MD -18.90, 95% CI -37.92 to 0.12). A similar pattern of results was observed between women with SUI who received PFMT plus either a continence pessary or duloxetine and those who received the continence pessary or duloxetine alone. In all these comparisons, the quality of the evidence for the reported critical outcomes ranged from moderate to very low.
AUTHORS' CONCLUSIONS
This systematic review found insufficient evidence to state whether or not there were additional effects by adding PFMT to other active treatments when compared with the same active treatment alone for urinary incontinence (SUI, UUI or MUI) in women. These results should be interpreted with caution as most of the comparisons were investigated in small, single trials. None of the trials in this review were large enough to provide reliable evidence. Also, none of the included trials reported data on adverse events associated with the PFMT regimen, thereby making it very difficult to evaluate the safety of PFMT.
Topics: Combined Modality Therapy; Electric Stimulation Therapy; Exercise Therapy; Female; Hot Temperature; Humans; Pelvic Floor; Pessaries; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Urinary Incontinence, Stress; Urinary Incontinence, Urge
PubMed: 26526663
DOI: 10.1002/14651858.CD010551.pub3 -
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