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International Journal of Gynaecology... May 2024Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. (Review)
Review
Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
BACKGROUND
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.
OBJECTIVES
Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure.
SEARCH STRATEGY AND SELECTION CRITERIA
Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.
DATA COLLECTION AND ANALYSIS
We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices.
MAIN RESULTS
Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls.
CONCLUSION
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Pessaries; Medical Device Legislation; Randomized Controlled Trials as Topic; Cervix Uteri; Pregnancy, Twin
PubMed: 37830250
DOI: 10.1002/ijgo.15169 -
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 -
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... Sep 2010Preterm delivery is a major health problem and contributes to more than 50% of the overall perinatal mortality. Cervical incompetence is one of the common causes of... (Review)
Review
BACKGROUND
Preterm delivery is a major health problem and contributes to more than 50% of the overall perinatal mortality. Cervical incompetence is one of the common causes of preterm birth to which different management strategies have been tried including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still a matter of controversy regarding the efficacy and the group of patients which 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.
OBJECTIVES
To evaluate the efficacy of cervical pessary for prevention of preterm birth in women with cervical incompetence.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2010), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (May 2010).
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 and crossover trials.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion.
MAIN RESULTS
The search identified two trials which we excluded. Three additional trials are ongoing. This review contains no included studies.
AUTHORS' CONCLUSIONS
The review did not identify any well-designed randomised clinical trial in order to confirm or refute the benefit of cervical pessary. However, there is evidence from non-randomised trials that showed some benefit of cervical pessary in preventing preterm birth. We are waiting for the results of three ongoing randomised controlled trials, assessing the role of cervical pessary in women with short cervix. There is a need for further well-designed randomised controlled trials.
Topics: Female; Humans; Pessaries; Pregnancy; Premature Birth
PubMed: 20824869
DOI: 10.1002/14651858.CD007873.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 Journal of Maternal-fetal &... May 2019The objective of this study is to evaluate the effectiveness and safety of cervical pessaries for the prevention of preterm birth. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The objective of this study is to evaluate the effectiveness and safety of cervical pessaries for the prevention of preterm birth.
METHODS
We searched PubMed, Embase, Web of Science, and other sources from inception to July 2016. This analysis referred to pregnant women with singleton/multiple viable fetus/fetuses, with or without cervical pessary placement.
RESULTS
Six randomized control trials and five cohort studies involving 3911 participants were included. Overall, cervical pessary placement was slightly associated with the decrease of spontaneous delivery less than 34 weeks (relative risk 0.65 [95% CI: 0.44-0.96]) and increased gestational age at delivery (weighted mean difference 1.03 weeks [95% CI: 0.37-1.70]) in multiple pregnancies, but not with poor perinatal outcomes. Pessary placement in singleton pregnancies did not show any difference. A planned subgroup analysis showed multiple pregnancies with shorter cervical length (≤25 mm) had a longer prolongation of pregnancy (weighted mean difference 2.08 weeks [95% CI: 1.35-2.82]).
CONCLUSION
This meta-analysis suggested pessary placement could slightly reduce the rate of spontaneous preterm delivery before 34 weeks, and increase gestational age at delivery in multiple pregnancies, but not in singleton pregnancies. More studies of high quality with detailed records are urgent to confirm the efficacy of this procedure.
Topics: Adult; Cervical Length Measurement; Cohort Studies; Female; Gestational Age; Humans; Infant, Newborn; Pessaries; Pregnancy; Pregnancy Outcome; Premature Birth; Randomized Controlled Trials as Topic
PubMed: 29212400
DOI: 10.1080/14767058.2017.1414795 -
The Cochrane Database of Systematic... Jul 2013For a long time pelvic floor muscle training (PFMT) has been the most common form of conservative (non-surgical) treatment for stress urinary incontinence (SUI).... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
For a long time pelvic floor muscle training (PFMT) has been the most common form of conservative (non-surgical) treatment for stress urinary incontinence (SUI). Weighted vaginal cones can be used to help women to train their pelvic floor muscles. Cones are inserted into the vagina and the pelvic floor is contracted to prevent them from slipping out.
OBJECTIVES
The objective of this review is to determine the effectiveness of vaginal cones in the management of female urinary stress incontinence (SUI).We wished to test the following comparisons in the management of stress incontinence: 1. vaginal cones versus no treatment; 2. vaginal cones versus other conservative therapies, such as PFMT and electrostimulation; 3. combining vaginal cones and another conservative therapy versus another conservative therapy alone or cones alone; 4. vaginal cones versus non-conservative methods, for example surgery or injectables.Secondary issues which were considered included whether:1. it takes less time to teach women to use cones than it does to teach the pelvic floor exercise; 2. self-taught use is effective;3. the change in weight of the heaviest cone that can be retained is related to the level of improvement;4. subgroups of women for whom cone use may be particularly effective can be identified.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Trials Register (searched 19 September 2012), MEDLINE (January 1966 to March 2013), EMBASE (January 1988 to March 2013) and reference lists of relevant articles.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials comparing weighted vaginal cones with alternative treatments or no treatment.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed studies for inclusion and trial quality. Data were extracted by one reviewer and cross-checked by the other. Study authors were contacted for extra information.
MAIN RESULTS
We included 23 trials involving 1806 women, of whom 717 received cones. All of the trials were small, and in many the quality was hard to judge. Outcome measures differed between trials, making the results difficult to combine. Some trials reported high drop-out rates with both cone and comparison treatments. Seven trials were published only as abstracts.Cones were better than no active treatment (rate ratio (RR) for failure to cure incontinence 0.84, 95% confidence interval (CI) 0.76 to 0.94). There was little evidence of difference for a subjective cure between cones and PFMT (RR 1.01, 95% CI 0.91 to 1.13), or between cones and electrostimulation (RR 1.26, 95% CI 0.85 to 1.87), but the confidence intervals were wide. There was not enough evidence to show that cones plus PFMT was different to either cones alone or PFMT alone. Only seven trials used a quality of life measures and no study looked at economic outcomes.Seven of the trials recruited women with symptoms of incontinence, while the others required women with urodynamic stress incontinence, apart from one where the inclusion criteria were uncertain.
AUTHORS' CONCLUSIONS
This review provides some evidence that weighted vaginal cones are better than no active treatment in women with SUI and may be of similar effectiveness to PFMT and electrostimulation. This conclusion must remain tentative until larger, high-quality trials, that use comparable and relevant outcomes, are completed. Cones could be offered as one treatment option, if women find them acceptable.
Topics: Female; Humans; Muscle Contraction; Pelvic Floor; Pessaries; Prostheses and Implants; Urinary Incontinence, Stress
PubMed: 23836411
DOI: 10.1002/14651858.CD002114.pub2 -
The Cochrane Database of Systematic... Jul 2011ncontinence 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
ncontinence 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 the effects of mechanical devices in the management of adult female urinary incontinence.
SEARCH STRATEGY
We searched the Cochrane Incontinence Group Specialised Register (searched 23 June 2010), EMBASE (January 1947 to 2010 Week 24), CINAHL (January 1982 to 11 June 2010) 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 5.0.25).
MAIN RESULTS
One new trial was identified and included in this update bringing the total to seven trials involving 732 women. Two 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 new 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 group 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; Exercise Therapy; Female; Humans; Muscle Contraction; Pelvic Floor; Pessaries; Prostheses and Implants; Randomized Controlled Trials as Topic; Tampons, Surgical; Urinary Incontinence; Urinary Sphincter, Artificial
PubMed: 21735385
DOI: 10.1002/14651858.CD001756.pub5 -
The Cochrane Database of Systematic... Feb 2013Pelvic organ prolapse is common, with some degree of prolapse seen in up to 50% of parous women in a clinic setting, although many are asymptomatic. The use of pessaries... (Review)
Review
BACKGROUND
Pelvic organ prolapse is common, with some degree of prolapse seen in up to 50% of parous women in a clinic setting, although many are asymptomatic. The use of pessaries (a passive mechanical device designed to support the vagina) to treat prolapse is very common, and up to 77% of clinicians use pessaries for the first line management of prolapse. A number of symptoms may be associated with prolapse and treatments include surgery, pessaries and conservative therapies. A variety of pessaries are described which aim to alleviate the symptoms of prolapse and avert or delay the need for surgery.
OBJECTIVES
To determine the effectiveness of pessaries (mechanical devices) for pelvic organ prolapse.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register of trials (searched 13 March 2012), which includes searches of CENTRAL, MEDLINE, PREMEDLINE and handsearching of conference proceedings, and handsearched the abstracts of two relevant conferences held in 2011. We also searched the reference lists of relevant articles.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in one arm of the study.
DATA COLLECTION AND ANALYSIS
Abstracts were assessed independently by two authors with arbitration from a third if necessary. Data extraction was completed independently for included studies by two review authors.
MAIN RESULTS
To date there is only one published randomised controlled trial assessing the use of pessaries in the treatment of pelvic organ prolapse.
AUTHORS' CONCLUSIONS
The review authors identified one randomised controlled trial comparing ring and Gellhorn pessaries. The results of the trial showed that both pessaries were effective for the approximately 60% of women who completed the study with no significant differences identified between the two types of pessary. However, methodological flaws were noted in the trial, as elaborated under risk of bias assessment. There is no consensus on the use of different types of device, the indications nor the pattern of replacement and follow-up care. There is an urgent need for randomised studies to address the use of pessaries in comparison with no treatment, surgery and conservative measures.
Topics: Female; Humans; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic; Rectal Prolapse; Urethral Diseases; Urinary Bladder Diseases; Uterine Prolapse
PubMed: 23450548
DOI: 10.1002/14651858.CD004010.pub3 -
The Cochrane Database of Systematic... Jun 2014Prostaglandins have been used for induction of labour since the 1960s. This is one of a series of reviews evaluating methods of induction of labour. This review focuses... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prostaglandins have been used for induction of labour since the 1960s. This is one of a series of reviews evaluating methods of induction of labour. This review focuses on prostaglandins given per vaginam, evaluating these in comparison with placebo (or expectant management) and with each other; prostaglandins (PGE2 and PGF2a); different formulations (gels, tablets, pessaries) and doses.
OBJECTIVES
To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol).
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2014) and bibliographies of relevant papers.
SELECTION CRITERIA
Clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment, with each other, or other methods listed above it on a predefined list of labour induction methods.
DATA COLLECTION AND ANALYSIS
We assessed studies and extracted data independently.
MAIN RESULTS
Seventy randomised controlled trials (RCTs) (11,487 women) are included. In this update seven new RCTs (778 women) have been added. Two of these new trials compare PGE2 with no treatment, four compare different PGE2 formulations (gels versus tablets, or sustained release pessaries) and one trial compares PGF2a with placebo. The majority of trials were at unclear risk of bias for most domains.Overall, vaginal prostaglandin E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours. The risk of uterine hyperstimulation with fetal heart rate changes is increased (4.8% versus 1.0%, risk ratio (RR) 3.16, 95% confidence interval (CI) 1.67 to 5.98, 15 trials, 1359 women). The caesarean section rate is probably reduced by about 10% (13.5% versus 14.8%, RR 0.91, 95% CI 0.81 to 1.02, 36 trials, 6599 women). The overall effect on improving maternal and fetal outcomes (across a variety of measures) is uncertain.PGE2 tablets, gels and pessaries (including sustained release preparations) appear to be as effective as each other, small differences are detected between some outcomes, but these maybe due to chance.
AUTHORS' CONCLUSIONS
Prostaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates. They increase the likelihood of cervical change, with no increase in operative delivery rates. PGE2 tablets, gels and pessaries appear to be as effective as each other, any differences between formulations are marginal but may be important.
Topics: Administration, Intravaginal; Dinoprost; Dinoprostone; Female; Humans; Labor, Induced; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Term Birth
PubMed: 24941907
DOI: 10.1002/14651858.CD003101.pub3