POP-Q Versus Upright MRI Distance Measurements: A Prospective Study in Patients with POP.

INTRODUCTION AND HYPOTHESIS: The gold standard for quantifying pelvic organ prolapse is the pelvic organ prolapse quantification (POP-Q) system; however, upright magnetic resonance imaging (MRI) is a promising new method. The objective of this study was to determine the correlation between POP-Q and MRI measurements of the bladder and cervix. METHODS: This prospective study included patients with prolapse in whom POP-Q points Aa or Ba and C were measured as standard care. MRI scans were performed in an upright position, and the distances of the lowest points of the bladder and cervix to the Pelvic Inclination Correction System (PICS) were calculated. Correlations between POP-Q and MRI-PICS measurements were determined using the Pearson correlation coefficient for normally distributed data and the Spearman's rank correlation coefficient for non-normally distributed data. RESULTS: A total of 63 patients were suitable for analysis. There was a moderate positive correlation between the POP-Q and MRI-PICS measurements for bladder (r(61) = 0.480, r < 0.001) and uterus (r(61) = 0.527, p < 0.001). Measurement differences between POP-Q and MRI-PICS of the bladder and uterus vary from -3.2 cm to 7.1 cm, and from -2.1 cm to 8.5 cm respectively. In 71.4% of patients more descent was seen on upright MRI than with POP-Q measurement for both bladder and uterus. For patients with similar POP-Q measurements, a high variation in MRI measurements of the bladder and uterus was found. CONCLUSION: Despite a moderate positive correlation, upright MRI shows a larger POP extent in 71.4% of the patients than POP-Q. A high variation in MRI measurements for patients with the same POP-Q measurement was seen.

Assessment of daily variation in pelvic anatomy in women with and without pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Symptoms of pelvic organ prolapse (POP) can affect quality of life and are reported to progress during the day, although this was never objectified. The aim of this study is to determine whether the pelvic anatomy changes during the day using upright magnetic resonance imaging (MRI), in POP patients and asymptomatic women. METHODS: In this prospective study 15 POP patients and 45 asymptomatic women were included. Upright MRI scans were obtained three times per day. The distances from the lowest points of the bladder and cervix to a standardized reference (pelvic inclination correction system) line were determined. A principal component analysis was performed on the levator plate (LP) shape. Statistical differences between time points and the groups were determined for the bladder, cervix, and LP shape. RESULTS: For all women a significant decrease in bladder and cervix height of -0.2 cm (p<0.001) was seen between morning/midday and afternoon scans. A significant difference in bladder descent during the day between POP patients and asymptomatic women was found (p=0.004). Individual differences in bladder position in the POP group of up to 2.2 cm between the morning and afternoon scan were reported. There was a significant difference in LP shape (p<0.001) between the groups but there were no significant changes during the day. CONCLUSIONS: This study found no clinically relevant pelvic anatomy changes during the day. Still, on an individual level differences can be large, so repeating clinical examination at the end of the day can be recommended in patients when anamnesis and physical examination do not match.

The added value of conventional defecography and MRI defecography in clinical decision making on treatment for posterior compartment prolapse.

INTRODUCTION AND HYPOTHESIS: Conventional defecography and MRI defecography can be requested as an additional test for diagnosing and differentiating the type of posterior compartment prolapse and/or obstructive defecation disorders. The objective of this study was to determine the added value of conventional defecography, conventional defecography and MRI defecography for clinical decision-making on treatment for patients with posterior compartment prolapse. METHODS: Four gynecologists were asked to fill in their treatment plan per patient for 32 cases for three different steps. Step 1 consisted of information on the anamnesis and physical examination (POP-Q). Step 2 consisted of Step 1, including conventional defecography (group A) or MRI defecography (group B). In Step 3, all gynecologists received the information on Step 1 including both conventional defecography and MRI defecography. Data analysis solely focused on the assessment of changes in the gynecological treatment plan of the posterior compartment. RESULTS: After Step 2 a change in treatment plan occurred in 37% and 48% of the women in groups A and B, respectively. Accordingly, after Step 3 (including all imaging data), a change in treatment plan occurred in 19% and 52% of the women in groups A and B, respectively. A change within the surgery group (when a different type of surgery was selected) was seen for a total of 11 cases in group A and 20 in group B in all steps combined. CONCLUSIONS: Both conventional defecography and MRI defecography had an large effect on the treatment plan for patients with posterior compartment prolapse. The dedicated added value of the imaging modality individually cannot be concluded yet.

Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).

BACKGROUND: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. METHODS: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. DISCUSSION: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. TRIAL REGISTRATION: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Vaginal prolapse repair with or without a midurethral sling in women with genital prolapse and occult stress urinary incontinence: a randomized trial.

INTRODUCTION AND HYPOTHESIS: We compared pelvic organ prolapse (POP) repair with and without midurethral sling (MUS) in women with occult stress urinary incontinence (SUI). METHODS: This was a randomized trial conducted by a consortium of 13 teaching hospitals assessing a parallel cohort of continent women with symptomatic stage II or greater POP. Women with occult SUI were randomly assigned to vaginal prolapse repair with or without MUS. Women without occult SUI received POP surgery. Main outcomes were the absence of SUI at the 12-month follow-up based on the Urogenital Distress Inventory and the need for additional treatment for SUI. RESULTS: We evaluated 231 women, of whom 91 randomized as follows: 43 to POP surgery with and 47 without MUS. A greater number of women in the MUS group reported absence of SUI [86 % vs. 48 %; relative risk (RR) 1.79; 95 % confidence interval (CI) 1.29-2.48]. No women in the MUS group received additional treatment for postoperative SUI; six (13 %) in the control group had a secondary MUS. Women with occult SUI reported more urinary symptoms after POP surgery and more often underwent treatment for postoperative SUI than women without occult SUI. CONCLUSIONS: Women with occult SUI had a higher risk of reporting SUI after POP surgery compared with women without occult SUI. Adding a MUS to POP surgery reduced the risk of postoperative SUI and the need for its treatment in women with occult SUI. Of women with occult SUI undergoing POP-only surgery, 13 % needed additional MUS. We found no differences in global impression of improvement and quality of life.

One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial.

INTRODUCTION AND HYPOTHESIS: For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. METHODS: We conducted a prospective randomized trial in which 179 women were allocated to 1-day or 3-day suprapubic catheterization. The primary outcome was the duration of catheterization. RESULTS: Mean duration of catheterization and hospital stay was significantly shorter in the 1-day catheterization group. The number of successful voiding trials was higher in the 3-day catheterization group (90.9% versus 79.3%), but this did not reach statistical significance. The percentage of urinary tract infection did not differ significantly between the groups (4.5% versus 2.4%). CONCLUSION: Starting a voiding trial 1 day after vaginal prolapse surgery leads to shorter duration of catheterization and hospital stay.

Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I) and in patients with genital prolapse and occult stress incontinence (CUPIDO II).

BACKGROUND: About 40% of all patients with genital prolapse report stress-incontinence. In about half of the 60% patients that do not report stress-incontinence, occult urinary stress-incontinence can be detected. In these patients stress-incontinence is masked due to kinking or compression of the urethra by the prolapse.In case surgical correction is indicated there are two strategies to manage patients with combined prolapse and (occult) stress incontinence. This strategy is either (i) a combination of prolapse surgery and stress-incontinence surgery or (ii) to correct the prolapse first and evaluate afterwards whether additional stress-incontinence surgery is indicated. The advantage of combining prolapse and stress-incontinence surgery is that only few patients report stress-incontinence following such combination. However, this combination has been associated with an increased risk on complications, of which the development of obstructive micturition symptoms, overactive bladder symptoms and bladder retention are the most important ones. Furthermore, combining two procedures may be unnecessary as performing only prolapse surgery may cure stress-incontinence. In the randomized CUPIDO trials both strategies are compared in patients with prolapse and evident stress incontinence (CUPIDO I trial) and in patients with prolapse and occult stress incontinence (CUPIDO II trial). METHODS/DESIGN: The CUPIDO trials are two multicenter randomized controlled trials in which women with stress urinary incontinence (SUI) or occult stress urinary incontinence (OSUI) are randomized to prolapse surgery combined with anti incontinence surgery (concomitant surgery) or to prolapse surgery only. Patients with at least stage 2 POP are eligible, women with evident SUI are randomized in CUPIDO I. Patients without SUI are eligible for CUPIDO II and will have urodynamic evaluation or a standardized redression test. Women with OSUI are randomized, women without OSUI are followed up but not randomized. The primary outcome measure is absence of SUI twelve months after surgery. Furthermore, economic evaluations are conducted, and the effectiveness of urodynamic investigation is evaluated against a non-invasive way to determine SUI in women with POP. A total of 450 women will be included in the study. TRIAL REGISTRATION: Trial registration http://www.trialregister.nl NTRR 1197 en 1070.

Clinical, biochemical, and molecular findings in three patients with 3-hydroxyisobutyric aciduria.

3-Hydroxyisobutyric aciduria is a rare entity and affected individuals display a range of clinical manifestations including dysmorphic features and neurodevelopmental problems in the majority of patients. Here, we present two novel patients with 3-hydroxyisobutyric aciduria. To our knowledge, these are the 11th and 12th cases of 3-hydroxyisobutyic aciduria reported. It is believed that a deficiency in 3-hydroxyisobutyrate dehydrogenase is the most likely cause of this disorder. Measurement of 3-hydroxyisobutyrate dehydrogenase activity in fibroblasts homogenates of the two newly identified patients and a previously reported patient, however, revealed similar activities as in control fibroblasts. Since other enzymes with overlapping substrate specificity could conceal abnormal 3-hydroxyisobutyrate dehydrogenase activity, we cloned a candidate human cDNA for 3-hydroxyisobutyrate dehydrogenase (HIBADH). By heterologous expression in Escherichia coli, we showed that the product of the HIBADH gene indeed displays 3-hydroxyisobutyrate dehydrogenase activity. Mutation analysis of the corresponding gene in the patients suffering from 3-hydroxyisobutyric aciduria revealed no mutations. We conclude that HIBADH is not the causative gene in 3-hydroxyisobutyric aciduria.