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Neurourology and Urodynamics Aug 2021This systematic review aimed to assess the completeness of exercise reporting in randomized controlled trials (RCTs) on pelvic floor muscle training (PFMT) for women... (Review)
Review
AIMS
This systematic review aimed to assess the completeness of exercise reporting in randomized controlled trials (RCTs) on pelvic floor muscle training (PFMT) for women with pelvic organ prolapse (POP).
METHODS
MEDLINE, Cochrane Central, CINHAL, Embase, SCOPUS, and PEDro databases were searched up to October 2020. Full-text RCTs comparing PFMT to any type of intervention among women with any type and stage of POP were eligible for inclusion. Completeness of intervention was evaluated with t20he template for intervention description and replication (TIDieR) and the consensus on exercise reporting template (CERT). Inter-rater agreement for each item of the tools was calculated.
RESULTS
Twenty-six RCTs were included. None of the studies completely reported all intervention descriptors. On average 57.1% (6.8 ± 2.4; out of 12) of the overall TIDieR items and 35.3% (6.7 ± 2.9; out of 19) of the CERT were well described. In particular, 7 and 5 items were completely reported more than 50% of the time for the TIDieR and CERT, respectively. Frequent shortcomings were the undetailed reporting of information regarding tailoring and modifications of exercises and their adherence. Detailed descriptions of exercise repetitions to enable replication were missing in 53.8%. According to the CERT, only 11.5% of the RCTs sufficiently described the main providers' characteristics.
CONCLUSION
The completeness of PFMT reporting for women with POP is still below desirable standards and it is insufficient to ensure transferability into practice. The present results may add relevant knowledge and contribute to improving adequate reporting of exercise.
Topics: Exercise; Exercise Therapy; Female; Humans; Pelvic Floor; Pelvic Organ Prolapse; Randomized Controlled Trials as Topic
PubMed: 34058016
DOI: 10.1002/nau.24712 -
BJS Open Jan 2021This systematic review and meta-analysis aimed to compare recurrence rates of rectal prolapse following ventral mesh rectopexy (VMR) and suture rectopexy (SR). (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
This systematic review and meta-analysis aimed to compare recurrence rates of rectal prolapse following ventral mesh rectopexy (VMR) and suture rectopexy (SR).
METHODS
MEDLINE, Embase, and the Cochrane Library were searched for studies reporting on the recurrence rates of complete rectal prolapse (CRP) or intussusception (IS) after SR and VMR. Results were pooled and procedures compared; a subgroup analysis was performed comparing patients with CRP and IS who underwent VMR using biological versus synthetic meshes. A meta-analysis of studies comparing SR and VMR was undertaken. The Methodological Items for Non-Randomized Studies score, the Newcastle-Ottawa Scale, and the Cochrane Collaboration tool were used to assess the quality of studies.
RESULTS
Twenty-two studies with 976 patients were included in the SR group and 31 studies with 1605 patients in the VMR group; among these studies, five were eligible for meta-analysis. Overall, in patients with CRP, the recurrence rate was 8.6 per cent after SR and 3.7 per cent after VMR (P < 0.001). However, in patients with IS treated using VMR, the recurrence rate was 9.7 per cent. Recurrence rates after VMR did not differ with use of biological or synthetic mesh in patients treated for CRP (4.1 versus 3.6 per cent; P = 0.789) and or IS (11.4 versus 11.0 per cent; P = 0.902). Results from the meta-analysis showed high heterogeneity, and the difference in recurrence rates between SR and VMR groups was not statistically significant (P = 0.76).
CONCLUSION
Although the systematic review showed a higher recurrence rate after SR than VMR for treatment of CRP, this result was not confirmed by meta-analysis. Therefore, robust RCTs comparing SR and biological VMR are required.
Topics: Digestive System Surgical Procedures; Humans; Intussusception; Randomized Controlled Trials as Topic; Rectal Prolapse; Recurrence; Surgical Mesh; Sutures
PubMed: 33609376
DOI: 10.1093/bjsopen/zraa037 -
The Cochrane Database of Systematic... Nov 2020Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an...
BACKGROUND
Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse. This is an update of a Cochrane Review first published in 2003 and last published in 2013.
OBJECTIVES
To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.
MAIN RESULTS
We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms. The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.
Topics: Bias; Female; Humans; Muscle Strength; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic; Rectal Prolapse; Urethral Diseases; Urinary Bladder Diseases; Uterine Prolapse
PubMed: 33207004
DOI: 10.1002/14651858.CD004010.pub4