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American Journal of Obstetrics and... Jun 2017Less postoperative pain typically is associated with a minimally invasive hysterectomy compared with a laparotomy approach; however, poor pain control can still be an... (Review)
Review
BACKGROUND
Less postoperative pain typically is associated with a minimally invasive hysterectomy compared with a laparotomy approach; however, poor pain control can still be an issue. Multiple guidelines exist for managing postoperative pain, yet most are not specialty-specific and are based on procedures that bear little relevance to a minimally invasive hysterectomy.
OBJECTIVE
The purpose of this study was to determine whether there is enough quality evidence within the benign gynecology literature to make non-opioid pain control recommendations for women who undergo a benign minimally invasive hysterectomy.
STUDY APPRAISAL AND SYNTHESIS METHODS
We queried PubMed, ClinicalTrials.gov, and Cochrane databases using MeSH terms: "postoperative pain," "perioperative pain," "postoperative analgesia," "pain management," "pain control," "minimally invasive gynecologic surgery," and "hysterectomy." A manual examination of references from identified studies was also performed. All PubMed published studies that involved minimally invasive hysterectomies through November 9, 2016, were included. This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were restricted to benign minimally invasive hysterectomies evaluating non-opioid pharmacologic therapies. Primary outcomes included amount of postoperative analgesics consumed and postoperative pain scores. Two reviewers independently completed an in-depth evaluation of each study for characteristics and results using an established database, according to inclusion/exclusion criteria. A risk assessment was performed, and a quality rating was assigned with the use of the Cochrane Collaboration's Grades of Recommendation, Assessment, Development and Evaluation approach.
RESULTS
Initially 1155 studies were identified, and 24 studies met all inclusion criteria. Based on limited data of varying quality, intravenous acetaminophen, anticonvulsants and dexamethasone demonstrate opioid-sparing benefits; ketorolac shows mixed results in laparoscopic hysterectomies. Paracervical blocks provide pain-reducing benefits in vaginal hysterectomies.
CONCLUSIONS
Convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. There is a clear need for more high-quality research that will evaluate each medication type for posthysterectomy pain control.
Topics: Acetaminophen; Analgesics; Analgesics, Opioid; Anesthesia, Obstetrical; Anticonvulsants; Dexamethasone; Female; Humans; Hysterectomy; Ketorolac; Laparoscopy; Minimally Invasive Surgical Procedures; Pain Management; Pain, Postoperative; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 28043841
DOI: 10.1016/j.ajog.2016.12.175 -
International Urogynecology Journal Oct 2021To systematically review evaluation guidelines of uncomplicated urinary incontinence (UI) in community-dwelling adult women to assess guidance available to the full...
INTRODUCTION AND HYPOTHESIS
To systematically review evaluation guidelines of uncomplicated urinary incontinence (UI) in community-dwelling adult women to assess guidance available to the full range of providers treating UI.
METHODS
Systematic literature search of eight bibliographic databases. We included UI evaluation guidelines written for medical providers in English after January 1, 2008.
EXCLUSION CRITERIA
guidelines for children, men, institutionalized women, peripartum- and neurologic-related UI. A quantitative scoring system included assessed components and associated recommendation level and clarity.
RESULTS
Twenty-two guidelines met the criteria. All guidelines included: history taking, UI characterization, physical examination (PE) performance, urinalysis, and post-void residual volume assessment. At least 75% included medical and surgical history assessment, other disease process exclusion, medication review, impact on quality of life ascertainment, observing stress UI, mental status assessment, performing a pelvic examination, urine culture, bladder diary, and limiting more invasive diagnostics procedures. Fifty to 75% included other important evaluation components (i.e., assessing obstetric history, bowel symptoms, fluid intake, patient expectations/preferences/values, obesity, physical functioning/mobility, other PE [abdominal, rectal, pelvic muscle, and neurologic], urethral hypermobility, and pad testing. Less than 50% of guidelines included discussing patient treatment goals. Guidelines varied in level of detail and clarity, with several instances of unclear or inconsistent recommendations within the same guideline and evaluation components identified only by inference from treatment recommendations. Non-specialty guidelines reported fewer components with a lesser degree of clarity, but this difference was not statistically significant (p = 0.20).
CONCLUSIONS
UI evaluation guidelines varied in level of comprehensiveness, detail, and clarity. This variability may lead to inconsistent evaluations in the work-up of UI, contributing to missed opportunities for individualized care.
Topics: Adult; Child; Female; Humans; Male; Obesity; Quality of Life; Urinary Incontinence; Urinary Incontinence, Stress
PubMed: 33881602
DOI: 10.1007/s00192-021-04777-z -
Journal of Vascular Surgery Nov 2022Ureteroarterial fistula (UAF) is lethal condition. However, no consensus has been reached regarding the diagnosis and treatment of UAF owing to its rarity. The aim of... (Review)
Review
OBJECTIVE
Ureteroarterial fistula (UAF) is lethal condition. However, no consensus has been reached regarding the diagnosis and treatment of UAF owing to its rarity. The aim of our report was to present an actual case of UAF and systematically review the symptoms, risk factors, diagnosis, and treatment of this condition.
METHODS
The case study was of a 52-year-old woman who had experienced a massive hemorrhage during urinary stent replacement. For the systematic review of studies of UAF, those written in English and reported from 1939 to 2020 were searched for on PubMed using the keywords "uretero-arterial fistula," "arterio-ureteral fistula," and "hematuria."
RESULTS
We included 121 studies with 235 patients (mean age, 66.0 years; 139 women [59.1%]) in our review. UAF had occurred most frequently in the common iliac artery (n = 112; 47.7%). Almost all patients (n = 232; 98.7%) had complained of hematuria. The risk factors for UAF were pelvic surgery (n = 205; 87.2%), the long-term use of urinary stents (n = 170; 72.3%), oncologic radiotherapy (n = 107; 45.5%), and malignancy (n = 159; 67.7%). Although computed tomography can detect various useful findings such as extravasation, pseudoaneurysm, hydronephrosis, and opacification of ureters, it was diagnostically useful for only one third of the cases. Angiography was useful for the diagnoses of UAF for 124 (66.3%) of the 187 patients (79.6%) who had undergone angiography. With regard to treatment, endovascular approaches have been widely used in recent years because their invasiveness is lesser than that of open surgical repair. In the era of endovascular therapy, the indications for open surgical repair include ureteral-intestinal fistula, abscess formation, and graft infection after endovascular therapy.
CONCLUSIONS
Computed tomography can be recommended as the first examination for patients with risk factors for UAF because of its usefulness. Subsequently, angiography should be considered because UAF can be treated using an endovascular approach after diagnostic angiography. The diagnosis and treatment of UAF can often be difficult; therefore, the important first step of diagnosis is suspecting the occurrence of UAF and using a multidisciplinary approach.
Topics: Humans; Female; Aged; Middle Aged; Vascular Fistula; Hematuria; Ureteral Diseases; Urinary Fistula; Iliac Artery; Stents
PubMed: 35709856
DOI: 10.1016/j.jvs.2022.05.015 -
Gynecologic Oncology Oct 2014To assess the association between diabetes mellitus (DM) and the incidence and disease-specific mortality of endometrial cancer (EC). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To assess the association between diabetes mellitus (DM) and the incidence and disease-specific mortality of endometrial cancer (EC).
METHODS
MEDLINE, EMBASE and conference abstracts of the 2011-2013 Annual Meetings of Society of Gynecological Oncology were searched for reports of original cohort studies that enrolled diabetic and non-diabetic women who were free of EC at baseline to compare the incidence and disease-specific mortality of EC by DM status. The included reports were examined for demographic characteristics of study populations, study design, effect measures and risk of bias. Statistical heterogeneity was evaluated with Chi-square test of the Cochrane Q statistics at the 0.05 significance level and I(2) statistic. Publication bias was assessed by visual examination of a funnel plot and the Egger's test for small-study effects.
RESULTS
Twenty-nine cohort studies (17 prospective, 12 retrospective) were eligible for this review, 23 of which reported EC incidence, five reported disease-specific mortality and one reported both. For incidence of EC among women with versus without DM, the summary relative risk (RR) was 1.89 (95%CI, 1.46-2.45; p<0.001) and the summary incidence rate ratio was 1.61 (95%CI, 1.51-1.71; p<0.001). The pooled RR of disease-specific mortality was 1.32 (95%CI, 1.10-1.60; p=0.003), while results in the studies reporting standardized mortality ratios were inconsistent. There remains considerable amount of clinical and methodological heterogeneity among the included studies; moreover, the hazard ratios for incident EC showed significant statistical heterogeneity and therefore were not quantitatively synthesized.
CONCLUSIONS
There is consistent evidence for an independent association between DM and an increased risk of incident EC, while the association between DM and EC-specific mortality remains uncertain. Further studies with better considerations for selection bias, information bias and confounding will further facilitate causal inference involving DM and EC.
Topics: Cause of Death; Cohort Studies; Diabetes Complications; Endometrial Neoplasms; Female; Humans; Incidence
PubMed: 25072931
DOI: 10.1016/j.ygyno.2014.07.095 -
The Cochrane Database of Systematic... Oct 2014Fibroids are common benign tumours arising in the uterus. Myomectomy is the surgical treatment of choice for women with symptomatic fibroids who prefer or want uterine... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fibroids are common benign tumours arising in the uterus. Myomectomy is the surgical treatment of choice for women with symptomatic fibroids who prefer or want uterine conservation. Myomectomy can be performed by conventional laparotomy, by mini-laparotomy or by minimal access techniques such as hysteroscopy and laparoscopy.
OBJECTIVES
To determine the benefits and harms of laparoscopic or hysteroscopic myomectomy compared with open myomectomy.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (inception to July 2014), the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of Controlled Trials (inception to July 2014), MEDLINE(R) (inception to July 2014), EMBASE (inception to July 2014), PsycINFO (inception to July 2014) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (inception to July 2014) to identify relevant randomised controlled trials (RCTs). We also searched trial registers and references from selected relevant trials and review articles. We applied no language restriction in these searches.
SELECTION CRITERIA
All published and unpublished randomised controlled trials comparing myomectomy via laparotomy, mini-laparotomy or laparoscopically assisted mini-laparotomy versus laparoscopy or hysteroscopy in premenopausal women with uterine fibroids diagnosed by clinical and ultrasound examination were included in the meta-analysis.
DATA COLLECTION AND ANALYSIS
We conducted study selection and extracted data in duplicate. Primary outcomes were postoperative pain, reported in six studies, and in-hospital adverse events, reported in eight studies. Secondary outcomes included length of hospital stay, reported in four studies, operating time, reported in eight studies and recurrence of fibroids, reported in three studies. Each of the other secondary outcomes-improvement in menstrual symptoms, change in quality of life, repeat myomectomy and hysterectomy at a later date-was reported in a single study. Odds ratios (ORs), mean differences (MDs) and 95% confidence intervals (CIs) were calculated and data combined using the fixed-effect model. The quality of evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods.
MAIN RESULTS
We found 23 potentially relevant trials, of which nine were eligible for inclusion in this review. The nine trials included in our meta-analysis had a total of 808 women. The overall risk of bias of included studies was low, as most studies properly reported their methods.Postoperative pain: Postoperative pain was measured on a visual analogue scale (VAS), with zero meaning 'no pain at all' and 10 signifying 'pain as bad as it could be.' Postoperative pain was significantly less, as determined by subjectively assessed pain score at six hours (MD -2.40, 95% CI -2.88 to -1.92, one study, 148 women, moderate-quality evidence) and 48 hours postoperatively (MD -1.90, 95% CI -2.80 to -1.00, two studies, 80 women, I² = 0%, moderate-quality evidence) in the laparoscopic myomectomy group compared with the open myomectomy group. This means that among women undergoing laparoscopic myomectomy, mean pain score at six hours and 48 hours would be likely to range from about three points lower to one point lower on a VAS zero-to-10 scale. No significant difference in postoperative pain score was noted between the laparoscopic and open myomectomy groups at 24 hours (MD -0.29, 95% CI -0.7 to 0.12, four studies, 232 women, I² = 43%, moderate-quality evidence). The overall quality of these findings is moderate; therefore further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.In-hospital adverse events: No evidence suggested a difference in unscheduled return to theatre (OR 3.04, 95% CI 0.12 to 75.86, two studies, 188 women, I² = 0%, low-quality evidence) and laparoconversion (OR 1.11, 95% CI 0.44 to 2.83, eight studies, 756 women, I² = 53%, moderate-quality evidence) when open myomectomy was compared with laparoscopic myomectomy. Only one study including 148 women reported injury to pelvic organs (no events were described in other studies), and no significant difference was noted between laparoscopic myomectomy and laparoscopically assisted mini-laparotomy myomectomy (OR 3.04, 95% CI 0.12 to 75.86). Significantly lower risk of postoperative fever was observed in the laparoscopic myomectomy group compared with groups treated with all types of open myomectomy (OR 0.44, 95% CI 0.26 to 0.77, I² = 0%, six studies, 635 women). This indicates that among women undergoing laparoscopic myomectomy, the risk of postoperative fever is 50% lower than among those treated with open surgery. No studies reported immediate hysterectomy, uterine rupture, thromboembolism or mortality. Six studies including 549 women reported haemoglobin drop, but these studies were not pooled because of extreme heterogeneity (I² = 97%) and therefore could not be included in the analysis.
AUTHORS' CONCLUSIONS
Laparoscopic myomectomy is a procedure associated with less subjectively reported postoperative pain, lower postoperative fever and shorter hospital stay compared with all types of open myomectomy. No evidence suggested a difference in recurrence risk between laparoscopic and open myomectomy. More studies are needed to assess rates of uterine rupture, occurrence of thromboembolism, need for repeat myomectomy and hysterectomy at a later stage.
Topics: Female; Fever; Humans; Hysteroscopy; Laparoscopy; Laparotomy; Leiomyoma; Pain Measurement; Pain, Postoperative; Randomized Controlled Trials as Topic; Uterine Myomectomy; Uterine Neoplasms
PubMed: 25331441
DOI: 10.1002/14651858.CD004638.pub3 -
The Cochrane Database of Systematic... Oct 2022Intentional endometrial injury is being proposed as a technique to improve the probability of pregnancy in women undergoing assisted reproductive technologies (ART) such... (Review)
Review
BACKGROUND
Intentional endometrial injury is being proposed as a technique to improve the probability of pregnancy in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF). Endometrial injury is often performed by pipelle biopsy and is a common gynaecological procedure with established safety. However, it causes a moderate degree of discomfort/pain and requires an additional pelvic examination. The effectiveness of this procedure outside of ART, in women or couples attempting to conceive via sexual intercourse or with intrauterine insemination (IUI), remains unclear.
OBJECTIVES
To assess the effectiveness and safety of intentional endometrial injury performed in infertile women or couples attempting to conceive through sexual intercourse or intrauterine insemination (IUI).
SEARCH METHODS
The Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Knowledge, and clinical trial registries were searched from inception to 21 May 2020, as were conference abstracts and reference lists of relevant reviews and included studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that evaluated any kind of intentional endometrial injury in women planning to undergo IUI or attempting to conceive spontaneously (with or without ovarian stimulation (OS)) compared to no intervention, a mock intervention, or intentional endometrial injury performed at a different time.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. Primary outcomes were live birth/ongoing pregnancy and pain experienced during the procedure. Due to high risk of bias associated with many of the studies, primary analyses of all review outcomes were restricted to studies at low risk of bias. Sensitivity analysis including all studies was then performed.
MAIN RESULTS
We included 22 RCTs (3703 women). Most of these studies included women with unexplained infertility. Intentional endometrial injury versus either no intervention or a sham procedure The primary analysis was restricted to studies at low risk of bias, which left only one study included. We are uncertain whether endometrial injury has an effect on the probability of live birth, as only one study is included in the analysis and the confidence interval is wide (risk ratio (RR) 1.11, 95% confidence interval (CI) 0.78 to 1.59; 1 RCT, 210 participants). Evidence suggests that if the chance of live birth with no intervention/a sham procedure is assumed to be 34%, then the chance with endometrial injury would be 27% to 55%. When all studies were included in the sensitivity analysis, we were uncertain whether endometrial injury improves live birth/ongoing pregnancy, as the evidence was of very low quality (RR 1.71, 95% CI 1.32 to 2.21; 8 RCTs, 1522 participants; I² = 16%). Evidence suggests that if the chance of live birth/ongoing pregnancy with no intervention/a sham procedure is assumed to be 13%, then the chance with endometrial injury would be 17% to 28%. A narrative synthesis conducted for the other primary outcome of pain during the procedure included studies measuring pain on a zero-to-ten visual analogue scale (VAS) or grading pain as mild/moderate/severe, and showed that most often mild to moderate pain was reported (6 RCTs, 911 participants; very low-quality evidence). Timing of intentional endometrial injury Four trials compared endometrial injury performed in the cycle before IUI to that performed in the same cycle as IUI. None of these studies reported the primary outcomes of live birth/ongoing pregnancy and pain during the procedure. One study compared endometrial injury in the early follicular phase (EFP; Day 2 to 4) to endometrial injury in the late follicular phase (LFP; Day 7 to 9), both in the same cycle as IUI. The primary outcome live birth/ongoing pregnancy was not reported, but the study did report the other primary outcome of pain during the procedure assessed by a zero-to-ten VAS. The average pain score was 3.67 (standard deviation (SD) 0.7) when endometrial injury was performed in the EFP and 3.84 (SD 0.96) when endometrial injury was performed in the LFP. The mean difference was -0.17, suggesting that on average, women undergoing endometrial injury in the EFP scored 0.17 points lower on the VAS as compared to women undergoing endometrial injury in the LFP (95% CI -0.48 to 0.14; 1 RCT, 110 participants; very low-quality evidence).
AUTHORS' CONCLUSIONS
Evidence is insufficient to show whether there is a difference in live birth/ongoing pregnancy between endometrial injury and no intervention/a sham procedure in women undergoing IUI or attempting to conceive via sexual intercourse. The pooled results should be interpreted with caution, as the evidence was of low to very low quality due to high risk of bias present in most included studies and an overall low level of precision. Furthermore, studies investigating the effect of timing of endometrial injury did not report the outcome live birth/ongoing pregnancy; therefore no conclusions could be drawn for this outcome. Further well-conducted RCTs that recruit large numbers of participants and minimise bias are required to confirm or refute these findings. Current evidence is insufficient to support routine use of endometrial injury in women undergoing IUI or attempting to conceive via sexual intercourse.
Topics: Female; Humans; Pregnancy; Abortion, Spontaneous; Coitus; Fertilization in Vitro; Infertility, Female; Insemination; Live Birth; Pain; Pregnancy Rate
PubMed: 36278845
DOI: 10.1002/14651858.CD011424.pub4 -
Ultrasound in Obstetrics & Gynecology :... Oct 2017In recent years, a large number of studies have been published on the clinical relevance of pelvic floor three-dimensional (3D) transperineal ultrasound. Several studies... (Review)
Review
OBJECTIVE
In recent years, a large number of studies have been published on the clinical relevance of pelvic floor three-dimensional (3D) transperineal ultrasound. Several studies compare sonography with other imaging modalities or clinical examination. The quality of reporting in these studies is not known. The objective of this systematic review was to determine the compliance of diagnostic accuracy studies investigating pelvic floor 3D ultrasound with the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines.
METHODS
Published articles on pelvic floor 3D ultrasound were identified by a systematic literature search of MEDLINE, Web of Science and Scopus databases. Prospective and retrospective studies that compared pelvic floor 3D ultrasound with other clinical and imaging diagnostics were included in the analysis. STARD compliance was assessed and quantified by two independent investigators, using 22 of the original 25 STARD checklist items. Items with the qualifier 'if done' (Items 13, 23 and 24) were excluded because they were not applicable to all papers. Each item was scored as reported (score = 1) or not reported (score = 0). Observer variability, the total number of reported STARD items per article and summary scores for each item were calculated. The difference in total score between STARD-adopting and non-adopting journals was tested statistically, as was the effect of year of publication.
RESULTS
Forty studies published in 13 scientific journals were included in the analysis. Mean ± SD STARD checklist score of the included articles was 16.0 ± 2.5 out of a maximum of 22 points. The lowest scores (< 50%) were found for reporting of handling of indeterminate results or missing responses, adverse events and the time interval between tests. Interobserver agreement for rating the STARD items was excellent (intraclass correlation coefficient, 0.77). An independent t-test showed no significant mean difference ± SD in total STARD checklist score between STARD-adopting and non-adopting journals (16.4 ± 2.2 vs 15.9 ± 2.6, respectively). Mean ± SD STARD checklist score for articles published in 2003-2009 was lower, but not statistically different, compared with those published in 2010-2015 (15.2 ± 2.5 vs 16.6 ± 2.4, respectively).
CONCLUSION
The overall compliance with reporting guidelines of diagnostic accuracy studies on pelvic floor 3D transperineal ultrasound is relatively good compared with other fields of medicine. However, specific checklist items require more attention when reported. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Anatomic Landmarks; Checklist; Female; Guideline Adherence; Guidelines as Topic; Humans; Imaging, Three-Dimensional; Pelvic Floor; Perineum; Quality Control; Reproducibility of Results; Ultrasonography
PubMed: 28000958
DOI: 10.1002/uog.17390 -
PloS One 2015To identify non-invasive tools for diagnosis of the major potentially life-threatening gynaecological emergencies (G-PLEs) reported in previous studies, and to assess... (Review)
Review
OBJECTIVE
To identify non-invasive tools for diagnosis of the major potentially life-threatening gynaecological emergencies (G-PLEs) reported in previous studies, and to assess their diagnostic accuracy.
METHODS
MEDLINE; EMBASE; Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library) were searched to identify all eligible studies published in English or French between January 1990 and December 2012. Studies were considered eligible if they were primary diagnostic studies of any designs, with a gold standard and with sufficient information for construction of a 2 × 2 contingency table, concerning at least one of the following G-PLEs: complicated ectopic pregnancy, complicated pelvic inflammatory disease, adnexal torsion and haemoperitoneum of any gynaecological origin. Extraction of data and assessment of study quality were conducted by two independent reviewers. We set the thresholds for the diagnostic value of signs retrieved at Sensibility ≥ 95% and LR-≤ 0.25, or Specificity ≥ 90% and LR+ ≥ 4.
RESULTS
We identified 8288 reports of diagnostic studies for the selected G-PLEs, 45 of which met the inclusion criteria. The methodological quality of the included studies was generally low. The most common diagnostic tools evaluated were transvaginal ultrasound (20/45), followed by medical history (18/45), clinical examination (15/45) and laboratory tests (14/45). Standardised questioning about symptoms, systolic blood pressure<110 mmHg, shock index>0.85, identification of a mass by abdominal palpation or vaginal examination, haemoglobin concentration <10 g/dl and six ultrasound and Doppler signs presented high performances for the diagnosis of G-PLEs. Transvaginal ultrasound was the diagnostic tool with the best individual performance for the diagnosis of all G-PLEs.
CONCLUSION
This systematic review suggests that blood pressure measurement, haemoglobin tests and transvaginal ultrasound are cornerstone examinations for the diagnosis of G-PLEs that should be available in all gynaecological emergency care services. Standardised questioning about symptoms could be used for triage of patients.
Topics: Adult; Diagnostic Techniques and Procedures; Emergencies; Female; Female Urogenital Diseases; Humans; Pregnancy; Pregnancy Complications; Sensitivity and Specificity
PubMed: 25723401
DOI: 10.1371/journal.pone.0114189 -
The Cochrane Database of Systematic... Mar 2024Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have... (Review)
Review
BACKGROUND
Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016.
OBJECTIVES
To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal 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, and two clinical trials registers (March 2022).
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue).
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination.
MAIN RESULTS
We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate). Transvaginal permanent mesh versus native tissue repair Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I = 34%; 17 studies, 2932 women; moderate-certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair. Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I = 35%; 17 studies, 2485 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I = 0%; 13 studies, 2206 women; moderate-certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I = 54%; 27 studies, 3916 women; low-certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs. Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I = 84%; 25 studies, 3680 women; very low-certainty evidence). Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I = 0%; 17 studies, 2001 women; moderate-certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I = 0%; 14 studies, 1997 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I = 27%; 16 studies, 1308 women; moderate-certainty evidence). There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data. Transvaginal absorbable mesh versus native tissue repair There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women). The effect of either form of repair was uncertain for bladder-related outcomes, dyspareunia, and quality of life. Transvaginal biological graft versus native tissue repair There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I = 0%; 8 studies, 1374 women; moderate-certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I = 0%; 6 studies, 899 women; moderate-certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I = 53%; 9 studies, 1278 women; low-certainty evidence). There was no evidence of a difference between the groups for dyspareunia or quality of life. Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis.
AUTHORS' CONCLUSIONS
While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence. While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3- to 10-year outcomes. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk-benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations. Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.
Topics: Female; Humans; Uterine Prolapse; Urinary Incontinence, Stress; Surgical Mesh; Dyspareunia; Pelvic Organ Prolapse; Urinary Incontinence; Urinary Bladder Diseases
PubMed: 38477494
DOI: 10.1002/14651858.CD012079.pub2 -
Journal of Personalized Medicine Jun 2023Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications... (Review)
Review
BACKGROUND
Forty percent of women will experience prolapse in their lifetime. Vaginal pessaries are considered the first line of treatment in selected patients. Major complications of vaginal pessaries rarely occur.
METHODS
PubMed and Embase were searched from 1961 to 2022 for major complications of vaginal pessaries using Medical Subject Headings (MeSH) and free-text terms. The keywords were pessary or pessaries and: vaginal discharge, incontinence, entrapment, urinary infections, fistula, complications, and vaginal infection. The exclusion criteria were other languages than English, pregnancy, complications without a prior history of pessary placement, pessaries unregistered for clinical practice (herbal pessaries), or male patients. The extracted data included symptoms, findings upon examination, infection, type of complication, extragenital symptoms, and treatment.
RESULTS
We identified 1874 abstracts and full text articles; 54 were assessed for eligibility and 49 met the inclusion criteria. These 49 studies included data from 66 patients with pessary complications amenable to surgical correction. Clavien-Dindo classification was used to grade the complications. Most patients presented with vaginal symptoms such as bleeding, discharge, or ulceration. The most frequent complications were pessary incarceration and fistulas. Surgical treatment included removal of the pessary under local or general anesthesia, fistula repair, hysterectomy and vaginal repair, and the management of bleeding.
CONCLUSIONS
Pessaries are a reasonable and durable treatment for pelvic organ prolapse. Complications are rare. Routine follow-ups are necessary. The ideal patient candidate must be able to remove and reintroduce their pessary on a regular basis; if not, this must be performed by a healthcare worker at regular intervals.
PubMed: 37511669
DOI: 10.3390/jpm13071056