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JPRAS Open Jun 2024Dermal fillers containing copolyamide are used for breast augmentation and are marketed under different labels, such as Aquafilling, Los Deline, Aqualift, and Activegel....
BACKGROUND
Dermal fillers containing copolyamide are used for breast augmentation and are marketed under different labels, such as Aquafilling, Los Deline, Aqualift, and Activegel. In recent years, the number of publications reporting complications after use of these fillers has increased.
METHODS
Through a computerized search following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of published studies on complications, treatment options, and radiological findings related to breast augmentation with dermal fillers containing copolyamide was performed. Publications between January 1, 2007, and January 23, 2023, were included. Retrieved studies were screened for inclusion and quality assessment. The Joanna Briggs checklist for case reports and the Strengthening the Reporting of Observational Studies in Epidemiology checklist for cross-sectional studies were used.
RESULTS
Sixteen studies met the inclusion criteria: 14 case reports and 2 retrospective cohort studies, including 196 women and 333 complications. Long-term complications (≥30 days after surgery) were described in 15 studies. The most commonly reported complications were nodules in the breast (130 patients), pain (92 patients), inflammation and/or infection (43 patients), breast deformities (35 patients), and migration of the filler to the pectoralis muscle, abdominal wall, thoracic wall, pubic area, back, or upper extremity (27 patients). The median time between injection of the dermal filler and any complication was 18 months, and the majority of patients with complications required surgical intervention.
CONCLUSION
Given the reports of severe complications months to years after injection of dermal fillers containing copolyamide and the lack of studies evaluating long-term safety, our interpretation is that dermal fillers containing copolyamide should not be used for breast augmentation.
PubMed: 38389650
DOI: 10.1016/j.jpra.2024.01.009 -
Obstetrics and Gynecology Jan 2024To systematically review the literature on use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To systematically review the literature on use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain.
DATA SOURCES
The ClinicalTrials.gov , PubMed, EMBASE, and Scopus databases were searched from inception to November 2022 by two independent assessors (B.L.K. and F.G.L.). Identified studies were screened by title and abstract and included after full-text review. Data extraction was subsequently performed and recorded in Microsoft Excel.
METHODS
This study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines after registration in PROSPERO (CRD42022289132). All randomized studies, prospective studies with more than five participants, and retrospective studies with more than 10 participants published in English or French and assessing the use of botulinum toxin for the treatment of pelvic floor tension myalgia and persistent pelvic pain in women were included. Meta-analyses were performed on randomized data.
TABULATION, INTEGRATION, AND RESULTS
Of 4,722 articles identified, 24 satisfied inclusion criteria. A meta-analysis of five randomized controlled trials totaling 329 participants demonstrated no differences in patient- and clinician-reported outcome measures, including pain, dyspareunia, sexual function, and vaginal manometry. Mean duration of follow-up was 6 months. A qualitative analysis of 14 prospective and four retrospective studies including 804 participants is supportive of botulinum toxin; however, the quality of data is low, and there is marked heterogeneity between studies.
CONCLUSION
Meta-analyses of randomized data do not support the use of botulinum toxin to treat pelvic floor tension myalgia and persistent pelvic pain. Failure of these data to confirm the findings of nonrandomized prospective studies that suggest a treatment benefit may be attributable to the absence of placebo control and confounding outcomes obtained from an active comparator group. Further randomized controlled trials with true placebo are strongly recommended.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42022289132.
Topics: Female; Humans; Botulinum Toxins, Type A; Prospective Studies; Neuromuscular Agents; Myalgia; Retrospective Studies; Pelvic Floor; Pelvic Pain; Randomized Controlled Trials as Topic
PubMed: 37797336
DOI: 10.1097/AOG.0000000000005388 -
The Journal of Sexual Medicine Feb 2024The pelvic floor muscles (PFMs) have been suggested to play a key role in sexual function and response in women. However, syntheses of the evidence thus far have been... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The pelvic floor muscles (PFMs) have been suggested to play a key role in sexual function and response in women. However, syntheses of the evidence thus far have been limited to interventional studies in women with pelvic pain or pelvic floor disorders, and these studies have failed to fully capture the involvement of the PFMs in a broader population.
AIM
We sought to appraise the evidence regarding the role of the PFMs in sexual function/response in women without pelvic pain or pelvic floor disorders. More specifically, we examined the following: (1) effects of treatment modalities targeting the PFMs on sexual function/response, (2) associations between PFM function and sexual function/response, and (3) differences in PFM function between women with and those without sexual dysfunction.
METHODS
We searched for all available studies in eight electronic databases. We included interventional studies evaluating the effects of PFM modalities on sexual outcomes, as well as observational studies investigating the association between PFM function and sexual outcomes or the differences in PFM function in women with and those without sexual dysfunction. The quality of each study was assessed using the Mixed Methods Appraisal Tool. Estimates were pooled using random-effects meta-analyses whenever possible, or a narrative synthesis of the results was provided.
MAIN OUTCOMES
The main outcomes were sexual function (based on a questionnaire)/sexual response (based on physiological test), and PFM function (assessment of the PFM parameters such as strength and tone based on various methods).
RESULTS
A total of 33 studies were selected, including 14 interventional and 19 observational studies, most of which (31/33) were deemed of moderate or high quality. Ten out of 14 interventional studies in women with and without sexual dysfunctions showed that PFM modalities had a significant effect on sexual function. Regarding the observational studies, a meta-analysis revealed a significant moderate association between PFM strength and sexual function (r = 0.41; 95% CI, 0.08-066). Of the 7 observational studies performed to assess sexual response, all showed that the PFMs were involved in arousal or orgasm. Conflicting results were found in the 3 studies that evaluated differences in PFM function in women with and those without sexual dysfunction.
CLINICAL IMPLICATIONS
Our results highlight the contribution of the PFMs in sexual function/response.
STRENGTHS AND LIMITATIONS
One strength of this review is the inclusion of a broad range of study designs and outcomes, allowing a thorough synthesis of evidence. However, interpretations of these data should consider risk of bias in the studies, small sample sizes, and the absence of control/comparison groups.
CONCLUSION
The findings of this review support the involvement of the PFMs in sexual function/response in women without pelvic pain or pelvic dysfunction. Well-designed studies should be performed to further investigate PFM modalities as part of the management of sexual dysfunction.
Topics: Female; Humans; Pelvic Floor; Pelvic Floor Disorders; Pelvic Pain; Sexual Behavior; Orgasm
PubMed: 38303662
DOI: 10.1093/jsxmed/qdad175 -
The Journal of Sexual Medicine Apr 2024Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far.
AIM
In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical.
METHODS
A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded.
OUTCOMES
The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ).
RESULTS
From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD, 6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, -0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias-1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength.
CLINICAL IMPLICATIONS
Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention.
STRENGTHS AND LIMITATIONS
Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data.
CONCLUSIONS
Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL.
Topics: Humans; Female; Vagina; Laser Therapy; Pelvic Floor; Radiofrequency Therapy; Sexual Dysfunction, Physiological
PubMed: 38508858
DOI: 10.1093/jsxmed/qdae028 -
European Journal of Obstetrics,... May 2024Women have a 11% lifetime risk of undergoing surgery for vaginal prolapse. Levator ani muscle (LAM) avulsion is one etiological factor associated with primary and... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Women have a 11% lifetime risk of undergoing surgery for vaginal prolapse. Levator ani muscle (LAM) avulsion is one etiological factor associated with primary and recurrent pelvic organ prolapse. Pelvic organ prolapse has been shown to greatly affect the quality of life and well-being of women. Conduct a meta-analysis identifying risk factors associated with LAM avulsion recognised on transperineal ultrasound (TPUS) or magnetic resonance imaging (MRI) in primiparous women after vaginal birth.
STUDY DESIGN
OVID Medline, Embase and the Cochrane Library from inception to January 2021 were searched. Review Manager 5.3 (The Cochrane Collaboration) was used to analyse data. Odds ratios (OR) with 95% confidence intervals (95% CIs) were calculated. The heterogeneity among studies was calculated using the Istatistic.
RESULTS
Twenty-five studies were eligible for inclusion (n = 9333 women). Major LAM avulsion was diagnosed in an average of 22 % (range 12.7-39.5 %) of cases. Twenty-two studies used TPUS and three used MRI to diagnose avulsion. Modifiable and non-modifiable risk factors were identified. Significant predictors identified were forceps (OR 6.25 [4.33 - 9.0]), obstetric anal sphincter injuries (OR 3.93 [2.85-5.42]), vacuum (OR 2.41 [1.40-4.16]), and maternal age (OR 1.06 [1.02-1.10]).
CONCLUSIONS
This is the first meta-analysis of both modifiable and non-modifiable risk factors associated with LAM avulsion. This information could be used to develop a clinically applicable risk prediction model to target postnatal women at risk of LAM avulsion with a view to prevent the onset of pelvic floor organ prolapse.
Topics: Pregnancy; Female; Humans; Delivery, Obstetric; Quality of Life; Risk Factors; Ultrasonography; Anal Canal; Pelvic Organ Prolapse; Pelvic Floor
PubMed: 38422805
DOI: 10.1016/j.ejogrb.2024.02.044 -
Journal of Obstetrics and Gynaecology... Dec 2023Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or... (Review)
Review
OBJECTIVES
Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or prevent pelvic organ prolapse. Vitamin D deficiency has consistently been associated with decreased muscle function, so it is assumed that it will affect the pelvic floor muscles. This paper systematically explores the differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
STUDY DESIGN
A systematic review was conducted through the PubMed, Google Scholar, Cochrane Library, and ScienceDirect databases using relevant keywords. Articles published in the last 10 years-from 2012 to 2022-that were written in English, that discuss the status or effect of vitamin D on pelvic organ prolapse, and that focus on 25 OH-vitamin D were included in the review.
RESULTS
In total, 717 articles were filtered but 8 articles met the criteria. A total of 1339 women with prolapse and without prolapse with ages ranging from 20 years to 78 years were included in the study. The studies found did not use the same standard threshold in determining deficiency status. Most studies have found that there are lower levels of vitamin D in women who have had pelvic organ prolapse. A total of 7 of 8 studies confirmed the comparison of vitamin D-25OH levels in women with pelvic organ prolapse and without pelvic organ prolapse at P < 0.05.
CONCLUSIONS
There are differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
Topics: Humans; Female; Pelvic Floor; Pelvic Organ Prolapse; Vitamin D; Calcifediol; Vitamins; Pessaries
PubMed: 37633644
DOI: 10.1016/j.jogc.2023.102198 -
Archives of Gynecology and Obstetrics Jun 2024The purpose of this systematic review is to present and compare results from studies that have been using autologous tissue for POP repair. (Comparative Study)
Comparative Study Review
OBJECTIVES
The purpose of this systematic review is to present and compare results from studies that have been using autologous tissue for POP repair.
METHODS
Systematic review was done according to the Cochrane Handbook for Systematic Reviews. We aimed to retrieve reports of published and ongoing studies on the efficacy and safety of autologous tissue in vaginal vault prolapse repair. The databases searched were MEDLINE (PubMed interface), Scopus, Cohrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov.
RESULTS
The success rate varied among studies. In fascia-lata group success rate reports varied from 83 to a 100%, with a median follow-up from 12 to 52 months among studies. Rectus fascia reported success rates from 87 to a 100% with a follow-up of 12 months to longest of 98 months.
CONCLUSION
Autologous tissues show satisfying outcomes in terms of safety and efficacy. Sacrocolpopexy procedure with fascia lata has better outcome in term of treatment of prolapse. Harvesting place on lateral side of buttock has more complications in comparison with rectus fascia but size of the graft can be wider in fascia-lata group.
Topics: Humans; Female; Pelvic Organ Prolapse; Fascia Lata; Gynecologic Surgical Procedures; Treatment Outcome; Transplantation, Autologous; Fascia; Rectus Abdominis
PubMed: 38703280
DOI: 10.1007/s00404-024-07531-0 -
Colorectal Disease : the Official... Feb 2024Physiotherapy is an established treatment strategy for low anterior resection syndrome (LARS). However, data on its efficacy are limited. This is in part due to the... (Review)
Review
AIM
Physiotherapy is an established treatment strategy for low anterior resection syndrome (LARS). However, data on its efficacy are limited. This is in part due to the inherent challenges in study design in this context. This systematic review aims to analyse the methodology of studies using pelvic floor physiotherapy for treatment of LARS to elucidate the challenges and limitations faced, which may inform the design of future prospective trials.
METHODOLOGY
A systematic review of the literature was undertaken through MEDLINE, Embase and Cochrane Library, yielding 345 unique records for screening. Five studies were identified for review. Content thematic analysis of study limitations was carried out using the Braun and Clarke method. Line-by-line coding was used to organize implicit and explicit challenges and limitations under broad organizing categories.
RESULTS
Key challenges fell into five overarching categories: patient-related issues, cancer-related issues, adequate symptomatic control, intervention-related issues and measurement of outcomes. Adherence, attrition and randomization contributed to potential bias within these studies, with imbalance in the baseline patient characteristics, particularly gender and baseline pelvic floor function scores. Outcome measurements consisted of patient-reported measures and quality of life measures, where significant improvements in bowel function according to patient-reported outcome measures were not reflected in the quality of life scores.
CONCLUSION
Upcoming trial design in the area of pelvic floor physiotherapy for faecal incontinence related to rectal cancer surgery can be cognisant of and design around the challenges identified in this systematic review, including the reduction of bias, exclusion of the placebo effect and the potential cultural differences in attitude towards a sensitive intervention.
Topics: Humans; Low Anterior Resection Syndrome; Rectal Neoplasms; Postoperative Complications; Pelvic Floor; Quality of Life; Physical Therapy Modalities
PubMed: 38173138
DOI: 10.1111/codi.16839 -
Asian Journal of Surgery May 2024
Meta-Analysis
Both thoracic and abdominal muscles can be used as effective indicators for sarcopenia in patients with lung cancer undergoing surgery: A systematic review and meta-analysis.
Topics: Humans; Sarcopenia; Lung Neoplasms; Abdominal Muscles
PubMed: 38302351
DOI: 10.1016/j.asjsur.2024.01.106 -
Rehabilitacion 2024This study aimed to evaluate the effectiveness of early pelvic muscle training in reducing urinary incontinence symptoms, improving quality of life, sexual function, and... (Meta-Analysis)
Meta-Analysis Review
[Effectiveness of early pelvic muscle training on pelvic floor strength, urinary incontinence symptoms, sexual function, and quality of life in post-radical prostatectomy patients: Systematic review of randomized clinical trials].
This study aimed to evaluate the effectiveness of early pelvic muscle training in reducing urinary incontinence symptoms, improving quality of life, sexual function, and increasing pelvic floor strength in post-radical prostatectomy patients. A search was carried out in 8 databases until October 26, 2022, the methodological quality and the risk of bias of 14 included studies (n=1236) were evaluated, moreover, the evidence and the meta-analysis were calculated. The intervention significantly reduced urinary incontinence symptoms compared to a control group (SMD=-2.80, 95% CI=-5.21 to -0.39, P=.02), with significant heterogeneity (I=83%; P=<.0001) and moderate evidence. In addition, it presented moderate evidence to improve quality of life, and very low evidence to improve sexual function and pelvic floor strength. These results should be viewed with caution due to the significant heterogeneity of the studies analysed.
Topics: Male; Humans; Pelvic Floor; Quality of Life; Randomized Controlled Trials as Topic; Urinary Incontinence; Prostatectomy
PubMed: 38141425
DOI: 10.1016/j.rh.2023.100828