Bias in research and conflict of interest: why should we care?
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Bias↗
Biomedical subjects
H P Dietz
Publications and source records attributed to H P Dietz.
The assessment of levator trauma: a comparison between palpation and 4D pelvic floor ultrasound.
AIMS: Major morphological abnormalities of the pubovisceral muscle are observed in 10-20% of women symptomatic of pelvic floor disorders. Such defects arise in childbirth and are associated with prolapse. While they are clearly evident on 3D ultrasound and MR imaging, such defects can be difficult to detect clinically. We intended to compare findings on palpation with the results of ultrasound imaging. MATERIAL AND METHODS: Fifty-five women were recruited in a prospective observational study and assessed by interview, vaginal examination by a trained pelvic floor physiotherapist, and 3D/4D pelvic floor ultrasound. The vaginal examination involved digital assessment of muscle strength (modified Oxford grading) and morphological abnormalities. The ultrasound examination involved acquisition of volume datasets taken at rest, on Valsalva and pelvic floor muscle contraction. Assessments were undertaken supine and after voiding. Ultrasound operator and physiotherapist were blind to each other's findings. RESULTS: A comparison of 3D ultrasound and palpation was possible in 54 cases. Average Oxford grading was weakly associated with reduction in hiatal dimensions on contraction (r = -0.32, P = 0.024). A marked increase in hiatal dimensions detected on palpation was associated with increased hiatal area on Valsalva (P = 0.027). Defects were observed in 7/54 (13%) on ultrasound and in 10/55 (18%) on palpation. There was poor agreement between the methods, with only two defects picked up equally by both methods. CONCLUSIONS: Palpation of the pubovisceral muscle correlates poorly with 3D/4D pelvic floor ultrasound imaging for the assessment of muscular defects.
Aged↗
Predicting operative delivery.
OBJECTIVE: Unplanned operative delivery (vaginal or abdominal) is associated with maternal anxiety, maternal and neonatal morbidity and increased resource use. We aimed to identify potential predictors for emergency operative delivery. METHODS: This was a prospective observational study of 202 nulliparous women in a tertiary antenatal unit between 36 and 40 weeks' gestation. The assessment included an interview, a vaginal examination for Bishop score (optional), and a translabial ultrasound examination performed with the woman in a supine position and after voiding to determine cervical length, bladder position on Valsalva, and fetal head engagement. Clinical data were obtained from the institutional obstetric database and patient records. RESULTS: In the late third trimester, body mass index (P = 0.016), maternal age at due date (P < 0.0001), history of Cesarean section in first-degree relatives (P = 0.009), Bishop score (P = 0.0004), cervical length (P = 0.001), bladder position on Valsalva (P = 0.003) and head engagement (P < 0.0001) were significantly associated with delivery mode. On multivariate logistic regression analysis, the best model for predicting normal vaginal delivery contained maternal age, history of Cesarean section, Bishop score and bladder position on Valsalva and had excellent ability to discriminate between normal vaginal delivery and operative delivery (c = 0.85). The model with the best ability to discriminate between vaginal delivery and Cesarean section contained the same parameters plus body mass index; this model performed even better (c = 0.87). CONCLUSIONS: Identification of women at increased risk of operative delivery appears feasible. A combination of clinical and ultrasound variables yielded a model that is likely to predict delivery mode accurately in up to 87% of cases. Such a model may become useful as an entry criterion for intervention trials in women at low or very high risk of operative delivery.
Adult↗
Why pelvic floor surgeons should utilize ultrasound imaging.
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Cystocele↗
The prevalence of major abnormalities of the levator ani in urogynaecological patients.
OBJECTIVES: While morphological abnormalities of the pubovisceral muscle have been described on magnetic resonance imaging (MRI), their relevance remains unclear. This study was designed to define prevalence and clinical significance of such abnormalities in urogynaecological patients. DESIGN: Prospective observational study. SETTING: Tertiary urogynaecological clinic. POPULATION: Three hundred and thirty-eight consecutive women referred for urodynamic assessment. METHODS: Participants underwent a clinical assessment, multichannel urodynamics and imaging with 3D translabial ultrasound. Blinded offline analysis was performed with the software 4D View (GE Kretztechnik, Zipf, Austria). MAIN OUTCOME MEASURES: Major morphological abnormalities of the pubovisceral muscle. RESULTS: Defects of the pubovisceral muscle were found in 15.4% of parous women. They were exclusively anteromedial (uni- or bilateral), only occurred among women who had delivered vaginally and were associated with anterior and central compartment prolapse (all P<0.001). There was no association with symptoms of bladder dysfunction or urodynamic findings. CONCLUSIONS: Major morphological abnormalities of the pubovisceral muscle are common in parous urogynaecological patients. They are associated with prolapse of the anterior and central compartment, but not with symptoms of bladder dysfunction or urodynamic findings.
Anal Canal↗
The role of childbirth in the aetiology of rectocele.
OBJECTIVE: Clinically, rectocele is common in parous women and assumed to be due to distension or tearing of the rectovaginal septum in labour. In a prospective study, we examined the prevalence of such defects in primiparae before and after childbearing in order to define the role of childbearing in the aetiology of rectocele. DESIGN: Prospective observational study. SETTING: Tertiary urogynaecological clinic. POPULATION: A total of 68 nulliparous women between 35 + 6 and 40 + 1 weeks of gestation. METHODS: Participants underwent a standardised interview and were assessed by translabial ultrasound. Presence and depth of a rectocele was determined on maximal Valsalva, as was descent of the rectal ampulla. Fifty-two women were reassessed 2-6 months postpartum. MAIN OUTCOME MEASURES: Presence of a true rectocele, rectal descent. RESULTS: True rectoceles were identified in 2 of the 68 women before childbirth and in 8 of the 52 women after childbirth (P = 0.02). After childbirth, the ampulla descended >22 mm further than before (P < 0.0001 on paired t test). Symptoms such as digitation (n = 2), straining at stool (n = 10) and incomplete emptying (n = 11) were not uncommon 2-6 months postpartum; but out of eight rectoceles, four were asymptomatic. CONCLUSIONS: True rectoceles occur in young nulliparae. However, childbirth is associated with an increase in prevalence and size of such defects.
Adult↗
Re: Midurethral Tissue Fixation System sling--a 'micromethod' for cure of stress incontinence--preliminary report and Tissue Fixation System posterior sling for repair of uterine/vault prolapse--a preliminary report.
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Adult↗
Childbirth and pelvic floor trauma.
The issue of traumatic damage to the pelvic floor in childbirth is attracting more and more attention amongst obstetric caregivers and laypersons alike. This is partly due to the fact that elective caesarean section as a potentially preventative intervention is increasingly available and perceived as safe. As there is a multitude of emotive issues involved, including health economics and the relative roles of healthcare providers, the discussion surrounding pelvic floor trauma in childbirth has not always been completely rational. However, after 25 years of urogynaecological research in this field it should be possible to determine whether pelvic floor trauma in childbirth is myth or reality, and, if real, whether it matters for the pathogenesis of incontinence and prolapse. On reviewing the available evidence, it appears that there are sufficient grounds to assume that vaginal delivery (or even the attempt at vaginal delivery) can cause damage to the pudendal nerve, the inferior aspects of the levator ani muscle and fascial pelvic organ supports. Risk factors for such damage have been defined and variously include operative vaginal delivery, a long second stage, and macrosomia. It is much less clear, however, whether such trauma is clinically relevant, and how important it is in the aetiology of pelvic floor morbidity later in life.
Cesarean Section↗
Measuring engagement of the fetal head: validity and reproducibility of a new ultrasound technique.
OBJECTIVE: Fetal head engagement can be assessed by translabial ultrasound and has been shown to be predictive of delivery mode. We attempted to validate the technique by comparing ultrasound with abdominal and vaginal palpation. Reproducibility was tested in a blinded test-retest series. METHODS: In a prospective clinical study, 139 nulliparous women between 35 + 3 and 40 + 4 weeks' gestation were assessed by translabial ultrasound, abdominal palpation of the fetal head (n = 139) and vaginal examination (n = 112). Ultrasound was performed using two methods, with the symphysis pubis as reference. A test-retest series was performed in 90 women. RESULTS: Ultrasound of head engagement correlated strongly with abdominal palpation, full Bishop scores and vaginal assessment (all P < 0.001 for Kendall's tau-b). Intraclass correlation coefficients (n = 90) for the two methods were 0.75 and 0.92, signifying excellent interobserver agreement. Reproducibility was higher for the method using the central symphyseal axis as reference. CONCLUSION: Quantitation of head engagement by translabial ultrasound is highly reproducible and correlates strongly with clinical measures of head engagement. We are now undertaking a prospective study to assess the predictive value of this new parameter for intrapartum events.
Female↗
Biometry of the pubovisceral muscle and levator hiatus by three-dimensional pelvic floor ultrasound.
OBJECTIVE: Until recently, magnetic resonance was the only imaging method capable of assessing the levator ani in vivo. Three-dimensional (3D) ultrasound has recently been shown to be able to demonstrate the pubovisceral muscle. The aim of this study was to define the anatomy of the levator hiatus in young nulliparous women with the help of 3D ultrasound. METHODS: In a prospective observational study, 52 nulligravid female Caucasian volunteers (aged 18-24 years) were assessed by two-dimensional (2D) and 3D translabial ultrasound after voiding whilst supine. Pelvic organ descent was assessed on Valsalva maneuver. Volumes were acquired at rest and on Valsalva maneuver, and biometric indices of the pubovisceral muscle and levator hiatus were determined in the axial and coronal planes. RESULTS: In the axial plane, average diameters of the pubovisceral muscle were 0.4-1.1 cm (mean 0.73 cm). Average area measurements were 7.59 (range, 3.96-11.9) cm2. The levator hiatus at rest varied from 3.26 to 5.84 (mean 4.5) cm in the sagittal direction, and from 2.76 to 4.8 (mean 3.75) cm in the coronal plane. The hiatus area at rest ranged from 6.34 to 18.06 (mean 11.25) cm2 increasing to 14.05 (6.67-35.01) cm(2) on Valsalva maneuver (P = 0.009). There were significant correlations between pelvic organ mobility and hiatus area at rest (P = 0.018 to P < 0.001) and on Valsalva maneuver (all P < 0.001). CONCLUSIONS: Biometric indices of the pubovisceral muscle and levator hiatus can be determined by 3D ultrasound. Significant correlations exist between hiatal area and pelvic organ descent. These data provide support for the hypothesis that levator ani anatomy plays an independent role in determining pelvic organ support.
Adolescent↗
Posterior compartment prolapse on two-dimensional and three-dimensional pelvic floor ultrasound: the distinction between true rectocele, perineal hypermobility and enterocele.
OBJECTIVES: Posterior compartment descent may encompass perineal hypermobility, isolated enterocele or a 'true' rectocele due to a rectovaginal septal defect. Our objective was to determine the prevalence of these conditions in a urogynecological population. METHODS: One hundred and ninety-eight women were clinically evaluated for prolapse and examined by translabial ultrasound, supine and after voiding, using three-dimensional capable equipment with a 7-4-MHz volume transducer. Downwards displacement of rectocele or rectal ampulla was used to quantify posterior compartment prolapse. A rectovaginal septal defect was seen as a sharp discontinuity in the ventral anorectal muscularis. RESULTS: Clinically, a rectocele was diagnosed in 112 (56%) cases. Rectovaginal septal defects were observed sonographically in 78 (39%) women. There was a highly significant relationship between ultrasound and clinical grading (P < 0.001). Of 112 clinical rectoceles, 63 (56%) cases showed a fascial defect, eight (7%) showed perineal hypermobility without fascial defect, and in three (3%) cases there was an isolated enterocele. In 38 (34%) cases, no sonographic abnormality was detected. Neither position of the ampulla nor presence, width or depth of defects correlated with vaginal parity. In contrast, age showed a weak association with rectal descent (r = -0.212, P = 0.003), the presence of fascial defects (P = 0.002) and their depth (P = 0.02). CONCLUSIONS: Rectovaginal septal defects are readily identified on translabial ultrasound as a herniation of rectal wall and contents into the vagina. Approximately one-third of clinical rectoceles do not show a sonographic defect, and the presence of a defect is associated with age, not parity.
Adult↗
Two-dimensional and three-dimensional ultrasound imaging of suburethral slings.
OBJECTIVE: Suburethral slings have become the most commonly performed anti-incontinence procedures in many developed countries. Three types of implant account for the majority of such surgery in Australia: tensionless vaginal tape (TVT), suprapubic arc procedure (SPARC) and intravaginal slingplasty (IVS). The aim of this study was to determine differences in position and mobility of these implants, and to determine whether such differences explain variations in clinical outcome. METHODS: In a prospective randomized controlled trial, 195 women were randomized to TVT (n = 67), IVS (n = 64) or SPARC (n = 64). Thirteen women were excluded from the study due to incomplete preoperative data. Of the remaining 182 women, 146 (50 TVT, 48 IVS, 48 SPARC) were seen between 2 and 23 months after their procedure (80%). After an interview, two-dimensional (2D) and three-dimensional (3D) pelvic floor ultrasound was performed. 3D-volume analysis was carried out on a computer with the help of proprietary software (GE Kretz 4D View). Assessors of ultrasound data were blinded against group allocation. RESULTS: There were no significant differences in subjective cure/improvement of stress or urge incontinence or overall subjective cure/improvement. Symptoms, including those of voiding dysfunction, did not vary between groups. All tapes could be imaged by ultrasound. TVT and SPARC were highly echogenic, with the SPARC generally flatter and of wider weave. The IVS seemed narrower and less echogenic. Tape position and mobility were similar, with a trend towards greater distances between tape and symphysis pubis and greater horizontal tape mobility in the SPARC group. CONCLUSIONS: The three types of suburethral sling, namely TVT, SPARC and IVS, investigated using 2D and 3D ultrasound, have comparable short-term clinical and anatomical outcomes.
Female↗
Bladder neck mobility is a heritable trait.
OBJECTIVE: Congenital connective tissue dysfunction may partly be responsible for female pelvic organ prolapse and urinary incontinence. We undertook a heritability study to determine whether mobility of the bladder neck, one of the main determinants of stress urinary incontinence, is genetically influenced. DESIGN: Heritability study using a twin model and structural equation modelling. SETTING: Queensland Institute of Medical Research, Brisbane, Australia. POPULATION: One hundred and seventy-eight nulliparous Caucasian female twins and their sisters (46 monozygotic pairs, 24 dizygotic pairs and 38 sisters) aged 18-24 years. METHODS: We performed translabial ultrasound, supine and after bladder emptying, for pelvic organ mobility. Urethral rotation and bladder neck descent were calculated using the best of three effective Valsalva manoeuvres. MAIN OUTCOME MEASURES: Bladder and urethral mobility on Valsalva assessed by urethral rotation, vertical and oblique bladder neck descent. RESULTS: Genetic modelling indicated that additive genes accounted for up to 59% of the variance for bladder neck descent. All remaining variance appeared due to environmental influences unique to the individual, including measurement error. CONCLUSION: A significant genetic contribution to the phenotype of bladder neck mobility appears likely.
Adolescent↗
Pelvic floor trauma in childbirth - myth or reality?
The issue of traumatic damage to the pelvic floor in childbirth is attracting more and more attention amongst obstetric caregivers and laypersons alike. This is partly due to the fact that elective Caesarean section, as a potentially preventative intervention, is increasingly available and perceived as safe. As there are a multitude of emotive issues involved, including health economics and the relative roles of healthcare providers, the discussion surrounding pelvic floor trauma in childbirth has not always been completely rational. However, after 25 years of urogynaecological research in this field it should be possible to determine whether pelvic floor trauma in childbirth is myth or reality. On reviewing the available evidence, it appears that there are sufficient grounds to assume that vaginal delivery (or even the attempt at vaginal delivery) can cause damage to the pudendal nerve, the caudal aspects of the levator ani muscle, fascial pelvic organ supports and the external and internal anal sphincter. Risk factors for such damage have been defined and variously include operative vaginal delivery, a long second stage, and macrosomia. It is much less clear, however, whether such trauma is clinically relevant, and how important it is in the aetiology of pelvic floor morbidity later in life.
Delivery, Obstetric↗
Voiding function in pregnancy and puerperium.
Bladder function changes significantly in pregnancy. This study prospectively examined voiding function in a nulliparous cohort. A total of 200 nulliparous women were seen twice during pregnancy and 2-5 months postpartum. Flowmetry, ultrasound estimation of residual urine and translabial ultrasound of bladder neck mobility were evaluated. The Liverpool nomograms were used to calculate maximum and average flow rate (MFR and AFR) centiles. Flowmetry was available on 186 women at 6-18 weeks, 165 women at 32-39 weeks and 162 women 2-5 months postpartum. Voided volumes decreased from 253 to 180 ml during pregnancy (p<0.001), increasing again to 198 ml postpartum. MFR centiles increased during pregnancy [from 49 (SD 28) to 58 (SD 29), p=0.003], and this trend continued postpartum [to 61.8 (SD 26.8), p<0.001]. Changes correlated weakly but significantly with changes in several parameters of bladder neck mobility (e.g. urethral rotation and MFR centiles, r=0.182, p=0.027). MFR and AFR centiles increase in pregnancy and with childbirth, and increases correlate weakly with changes in bladder neck mobility.
Adolescent↗
Symptoms of voiding dysfunction: what do they really mean?
Many women presenting with pelvic floor dysfunction will complain of voiding symptoms. This study examines the relationship between such symptoms and uroflowmetry parameters in 414 women with complaints of pelvic floor dysfunction who underwent free uroflowmetry with a weight transducer type flowmeter. Symptoms of voiding dysfunction were ascertained by interview, with symptoms rated positive if they occurred more than occasionally. Symptoms were correlated with maximum urine flow rate and maximum urine flow rate centiles: 356 women voided between 50 and 600 ml; these datasets were used for analysis. Average age was 57.4 years (range: 17-86). Symptoms of voiding dysfunction were common (62%): 26% of women described hesitancy, 28% a poor stream, 26% stop- start voiding, 15% straining to void, and 35% incomplete emptying/need to revoid. As a group, symptoms of voiding dysfunction were associated with reduced maximum urine flow rate centiles (28.1 vs 36.3, p= 0.011). The strength of the association varied markedly, with only hesitancy (p=0.002), poor stream (p<0.001), and stop-start voiding (p=0.014) reaching significance. Hesitancy, poor stream, and stop-start voiding were the only symptoms predictive of voiding impairment. Straining to void and the sensation of incomplete emptying or the need to revoid were not associated with a significant reduction in maximum flow rate centiles.
Adolescent↗
Laparoscopic colposuspension versus urethropexy: a case-control series.
Laparoscopic colposuspension (LC) was first described in the early 1990s as a technique distinct from open Burch colposuspension. Subsequently, however, LC was closely modelled along the lines of the Burch technique, and the distinct features of the original urethropexy (UP) were largely disregarded. In this case-control series the authors aimed to compare symptoms and anatomical outcomes after standard LC and urethropexy +/- paravaginal repair. The design was a clinical retrospective case-control trial. The setting was the urogynaecology and endogynaecology services of tertiary hospitals. Fifty patients after LC and 50 women after UP surgery, matched for age, body mass index, previous surgery, pre-existing urge incontinence and length of follow-up (1.01 year, range 0.02-3.54 years) for LC and 0.98 years (range 0.06-3.55 years) for UP). Intervention consisted of standardised interview and translabial ultrasound imaging. There were no significant differences for subjective cure of stress incontinence (80% for UP vs. 74% for LC), postoperative urge incontinence, frequency and nocturia. Significantly more UP patients complained of voiding dysfunction (p=0.01). Significant differences were found for urethral rotation, position of the bladder neck on Valsalva and bladder neck descent on Valsalva (all p<0.001). Both procedures were shown to be effective in curing stress incontinence. The incidence of bladder symptoms was comparable, with the exception of voiding difficulty. Significant differences were observed regarding anatomical appearances, with urethropexies showing more recurrent bladder neck hypermobility and cystocele.
Adult↗
TVT and Sparc suburethral slings: a case-control series.
Two midurethral slings, TVT and Sparc, are the subject of this case-control series aimed at assessing sling placement, voiding function, bladder symptoms and patient satisfaction. Thirty-seven Sparc and 69 TVT patients were matched for age, body weight, pre-existing urge incontinence, preoperative voiding, concomitant surgery and length of follow-up (mean 0.6, range 0.1-1.5 years). There were no significant differences for subjective cure/improvement, satisfaction or symptoms of incontinence. The clinical stress test was positive in 8/37 Sparc vs 4/69 TVT patients ( p=0.019). The TVT had a more negative effect ( p=0.001) on postoperative voiding. The Sparc was situated more cranially at rest and further from the symphysis pubis, and was more mobile ( p<0.001) on Valsalva. There are significant differences in medium-term outcomes after TVT and Sparc, affecting tape placement, mobility, effect on voiding function and objective stress continence. Patient satisfaction and subjective cure rates seem similar.
Case-Control Studies↗