A nationwide survey concerning practices in pessary use for pelvic organ prolapse in The Netherlands: identifying needs for further research

Introduction and hypothesis: To identify practice variation in management of patients with a vaginal pessary for pelvic organ prolapse (POP). Methods: A nationwide survey was sent to all Dutch gynecologists with a special interest in urogynecology. Results: The response rate was 59 %. Of the respondents, 13 % had a written protocol for pessary treatment in their department. Pessary treatment was proposed by 69 % of respondents as a treatment option. Counseling about side effects varied. All respondents provided information concerning the possibility of serious vaginal discharge. Concerning this side effect, 15 % of the respondents stated that it occurs in 5 – 20 % of patients, 27 % that it occurs in 20 – 40 % of patients, and 57 % that it occurs in more than 40 % of patients. Another item concerned counseling for the likelihood of vaginal blood loss. All respondents provided information concerning the possibility of vaginal blood loss. Concerning this side effect, 53 % of the respondents stated that it occurs in 5 – 20 % of patients, 33 % that it occurs in 20 – 40 %, and 14 % that it occurs in more than 40 % of patients. Follow-up after initial placement was done by 69 % of the respondents at 2 – 6 weeks, by 2 % at 8 weeks, and by 29 % at 12 weeks or more. Most (98 %) of the respondents extended the interval between visits when the patient had no complaints, and 96 % of the respondents reported that they routinely instruct patients about self-management. Conclusions: Pessaries are suggested as a treatment option by a majority of gynecologists, but practice varies widely. We consider that the variation in practice is due to a lack of available protocols and lack of evidence

Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial)

Contains fulltext : 97471.pdf (publisher's version ) (Open Access)BACKGROUND: Pelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life. Vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterine prolapse. Several studies have shown that sacrospinous fixation in case of uterine prolapse is a safe and effective alternative to vaginal hysterectomy. However, no large randomized trials with long-term follow-up have been performed to compare efficacy and quality of life between both techniques.The SAVE U trial is designed to compare sacrospinous fixation with vaginal hysterectomy in the treatment of uterine prolapse stage 2 or higher in terms of prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery and sexual functioning. METHODS/DESIGN: The SAVE U trial is a randomized controlled multi-center non-inferiority trial. The study compares sacrospinous fixation with vaginal hysterectomy in women with uterine prolapse stage 2 or higher. The primary outcome measure is recurrence of uterine prolapse defined as: uterine descent stage 2 or more assessed by pelvic organ prolapse quantification examination and prolapse complaints and/or redo surgery at 12 months follow-up. Secondary outcomes are subjective improvement in quality of life measured by generic (Short Form 36 and Euroqol 5D) and disease-specific (Urogenital Distress Inventory, Defecatory Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments, complications following surgery, hospital stay, post-operative recovery and sexual functioning (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and considering an upper-limit of 7% to be non-inferior (beta 0.2 and one sided alpha 0.025), 104 patients are needed per group. DISCUSSION: The SAVE U trial is a randomized multicenter trial that will provide evidence whether the efficacy of sacrospinous fixation is similar to vaginal hysterectomy in women with uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1866

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

INTRODUCTION: We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. METHODS: We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. RESULTS: Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = -0.013; P = 0.918). CONCLUSIONS: Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues

Training in obstetrics and gynaecology in the Netherlands

This article gives global insights on past, present and future training in obstetrics and gynaecology in the Netherlands. Comparisons are made with the British syste

Voiding dysfunction after vaginal prolapse surgery: etiology, prevention and treatment

Veertien procent van de patiënten die een vaginale hersteloperatie onderging kan hierna niet goed plassen. Robert Hakvoort laat zien dat de ernst van de blaasverzakking van invloed is, maar ook de postoperatieve onrust bij de patiënt. Uit een enquête onder gynaecologen blijkt dat de wijze en de duur van behandeling van de complicatie enorm varieert. Uit twee gerandomiseerde studies blijkt dat de duur van de behandeling van de plasproblemen kan worden bekort. Dat kan het best door intermitterend katheteriseren (het op vaste tijden legen van de urineblaas met behulp van een katheter)

Effect of pessary cleaning and optimal time interval for follow-up: a prospective cohort study

Introduction and hypothesis: The objective of this study was to determine the efficacy of routine follow-up visits for pessary cleaning, the effect of extended time intervals between visits and the proportion of patients being able to self-manage their pessary for pelvic organ prolapse (POP). Methods: We conducted a prospective cohort study in patients with a stage ≥II POP without previous POP surgery. All patients received a pessary as primary treatment. Our main outcome measure was a difference ≥2 in median visual analogue scale (VAS) scores (for pain, discharge, irritation) 1 week before and 1 week after cleaning. Measurements were performed after 3- and 9-month cleaning intervals. For the evaluation of the effect of cleaning, 132 patients (3 months’ follow-up) and 87 patients (12 months’ follow-up) were available for analysis. For the evaluation of the effect of the lengthening interval, 123 patients were available. Results: Self-management was performed in 45.2% of patients at 1 year. In 93.1% of patients, no differences were observed in pre-and post-cleaning VAS scores (effect of cleaning) on vaginal pain. Nor was there a difference in discharge (72.4%) or irritation 85.1% (p = 0.00). No differences were observed in pre-cleaning VAS scores for vaginal pain, discharge and irritation when the interval was lengthened from 3 to 9 months. No serious adverse events occurred. Conclusions: There is no proven benefit of regular follow-up visits to clean a pessary. Also, the length of the cleaning interval does not seem to matter

Predicting short-term urinary retention after vaginal prolapse surgery

AIMS: Identification of risk factors for urinary retention after vaginal prolapse surgery. METHODS: The medical records of 345 women undergoing surgical correction for symptomatic pelvic organ prolapse were analyzed. Independent risk factors for the development of post-operative urinary retention were identified by performing univariate and multivariate logistic regression analysis. Variables included in the analysis were age, parity, body mass index, previous prolapse surgery, previous hysterectomy, menopausal status, degree of prolapse, type of anesthesia, type and technique of surgery, operation time, intra-operative blood loss, preoperative urinary stress-incontinence, and other co-morbidities. Main outcome measure was the occurrence of urinary retention defined as a residual volume after voiding higher than 200 ml as measured by bladder scan. RESULTS: High grade cystocele (OR 2.5, CI 1.3-4.7), performing levator plication (OR 4.3, CI 2.0-9.3), performing Kelly plication (OR 5.1, CI 1.7-15.5) and amount of intra-operative blood loss (OR 1.4 per 100 ml, CI 1.1-1.8) were identified as independent risk factors for the occurrence of urinary retention after vaginal prolapse surgery. CONCLUSIONS: Urinary retention after vaginal prolapse surgery occurs more frequently in women with larger cystoceles, severe intra-operative blood loss and the application of levator plication and Kelly plicatio

Delivery-related risk factors for covert postpartum urinary retention after vaginal delivery

Postpartum urinary retention (PUR) is a common consequence of bladder dysfunction after vaginal delivery. Patients with covert PUR are able to void spontaneously but have a postvoid residual bladder volume (PVRV) of ≥150 mL. Incomplete bladder emptying may predispose to bladder dysfunction at a later stage of life. The aim of this cross-sectional study was to identify independent delivery-related risk factors for covert PUR after vaginal delivery in order to identify women with an increased risk of covert PUR. The PVRV of women who delivered vaginally was measured after the first spontaneous micturition with a portable bladder-scanning device. A PVRV of 150 mL or more was defined as covert PUR. Independent risk factors for covert PUR were identified in multivariate regression analysis. Of 745 included women, 347 (47%) were diagnosed with covert PUR (PVRV ≥150 mL), of whom 197 (26%) had a PVRV ≥250 mL (75th percentile) and 50 (7%) a PVRV ≥500 mL (95th percentile). In multivariate regression analysis, episiotomy (OR 1.7, 95% CI 1.02 - 2.71), epidural analgesia (OR 2.08, 95% CI 1.36 - 3.19) and birth weight (OR 1.03, 95% CI 1.01 - 1.06) were independent risk factors for covert PUR. Opioid analgesia during labour (OR 3.19, 95% CI 1.46 - 6.98), epidural analgesia (OR 3.54, 95% CI 1.64 - 7.64) and episiotomy (OR 3.72, 95% CI 1.71 - 8.08) were risk factors for PVRV ≥500 mL. Episiotomy, epidural analgesia and birth weight are risk factors for covert PUR. We suggest that the current cut-off values for covert PUR should be reevaluated when data on the clinical consequences of abnormal PVRV become availabl

Comparison of clean intermittent and transurethral indwelling catheterization for the treatment of overt urinary retention after vaginal delivery: a multicentre randomized controlled clinical trial

Overt postpartum urinary retention (PUR) is the inability to void after delivery and affects up to 7% of patients. Clean intermittent catheterization (CIC) and transurethral indwelling catheterization (TIC) are both standard treatments, but have not previously been compared. Clinical guidelines on postpartum bladder management are lacking. A total of 85 patients were randomised for TIC (n=45) and CIC (n=40). In total 68 patients (34 patients with TIC and 34 patients with CIC) completed the UDI-6 questionnaire 3 months after delivery.. Patients allocated to TIC received an indwelling catheter for 24 h and if necessary, another catheter for 48 h. Patients with CIC were intermittently catheterized or taught to self-catheterize until adequate voiding with a postvoid residual volume (PVRV) of <150 mL was achieved. The primary outcome was the presence of bothersome micturition symptoms as measured using the Dutch-validated Urogenital Distress Inventory (UDI-6). Only seven patients (10%) reported bothersome micturition problems 3 months after delivery. No significant differences in the occurrence of micturition symptoms were found. Median PVRV was 800 mL in the CIC group and 650 mL in the TIC group. PVRV was ≥1,000 mL in 24% of the patients. The median duration of catheterization was significantly shorter in the CIC group than in the TIC group (12 h vs. 24 h, p < 0,01). In patients with CIC, 35% required only one catheterization before complete bladder emptying occurred. The duration of treatment was not related to the initial PVRV. Both treatments were equally well accepted by the patients. In patients with overt PUR, CIC is the preferred treatment as a considerable percentage of patients appear to be over-treated when the standard duration of TIC is 24 h. The occurrence of micturition symptoms is not associated with the catheterization method used. CIC is well tolerated in patients with overt PU

Delivery-related risk factors for covert postpartum urinary retention after vaginal delivery

INTRODUCTION AND HYPOTHESIS: Postpartum urinary retention (PUR) is a common consequence of bladder dysfunction after vaginal delivery. Patients with covert PUR are able to void spontaneously but have a postvoid residual bladder volume (PVRV) of ≥150 mL. Incomplete bladder emptying may predispose to bladder dysfunction at a later stage of life. The aim of this cross-sectional study was to identify independent delivery-related risk factors for covert PUR after vaginal delivery in order to identify women with an increased risk of covert PUR. METHODS: The PVRV of women who delivered vaginally was measured after the first spontaneous micturition with a portable bladder-scanning device. A PVRV of 150 mL or more was defined as covert PUR. Independent risk factors for covert PUR were identified in multivariate regression analysis. RESULTS: Of 745 included women, 347 (47 %) were diagnosed with covert PUR (PVRV ≥150 mL), of whom 197 (26 %) had a PVRV ≥250 mL (75th percentile) and 50 (7 %) a PVRV ≥500 mL (95th percentile). In multivariate regression analysis, episiotomy (OR 1.7, 95 % CI 1.02 - 2.71), epidural analgesia (OR 2.08, 95 % CI 1.36 - 3.19) and birth weight (OR 1.03, 95 % CI 1.01 - 1.06) were independent risk factors for covert PUR. Opioid analgesia during labour (OR 3.19, 95 % CI 1.46 - 6.98), epidural analgesia (OR 3.54, 95 % CI 1.64 - 7.64) and episiotomy (OR 3.72, 95 % CI 1.71 - 8.08) were risk factors for PVRV ≥500 mL. CONCLUSIONS: Episiotomy, epidural analgesia and birth weight are risk factors for covert PUR. We suggest that the current cut-off values for covert PUR should be reevaluated when data on the clinical consequences of abnormal PVRV become available