Pessaries for pelvic organ prolapse: evaluation of vaginal discharge and pain during pessary cleaning in an outpatient setting.

INTRODUCTION AND HYPOTHESIS: Pessary treatment for pelvic organ prolapse (POP) is effective and safe, but long-term continuation is low. Pain and vaginal discharge may play a role. This study was aimed at evaluating vaginal discharge and pain during pessary cleaning in an outpatient setting and in continuous pessary use. METHODS: Women with POP who attended the outpatient clinic for pessary cleaning between January and October 2021 were included. Primary outcome was pain during removal and reinsertion of the pessary, measured by an 11-point numeric rating scale (NRS). Secondary outcome was vaginal discharge, measured by the NRS and Patient Global Impression of Change scale (PGI-C). Multiple linear regression analysis was used to identify associated variables for pain and discharge. RESULTS: A total of 150 women were included. Mean NRS during pessary removal was 4.3 (± 2.7), with 25% of women scoring a 7 or higher. Mean NRS during reinsertion was 1.8 (± 2.0). A smaller genital hiatus and presence of vaginal atrophy or vulvar skin disease were associated with pain during pessary removal. Mean NRS for vaginal discharge was 2.5 (± 2.3). Twenty-five percent of women reported that their vaginal discharge was "(very) much worse" than before they used a pessary. Presence of vaginal erosions was associated with vaginal discharge in this study population. CONCLUSIONS: Removing a pessary in an outpatient setting is a painful procedure for many women who use a pessary continuously. Moreover, 25% of these women experience an increase in vaginal discharge while using a pessary. Future research should focus on reducing these disadvantages.

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.

Accuracy of postvoid residual volumes after vaginal delivery: a prospective equivalence study to compare an automatic scanning device with transurethral catheterization.

INTRODUCTION AND HYPOTHESIS: Abnormal postvoid residual volumes (PVRV) after delivery are common in daily clinical practice. By using an automatic scanning device, unnecessary catheterizations can be prevented. The aim of this study was to determine the accuracy of PVRV after vaginal delivery measured by an automatic scanning device through a comparison with transurethral catheterization. MATERIALS AND METHODS: This prospective observational equivalence study was performed in patients who delivered vaginally between June 2012 and May 2017 in three teaching hospitals in The Netherlands. After the first spontaneous void after delivery, postvoid residual volume (PVRV) was measured with a portable automatic scanning device (BladderScan® BVI 9400). Directly afterward, it was measured by catheterization. Correlation between measurements was calculated using Spearman's correlation coefficient and agreement plot. The primary outcome was to validate the correlation between the BladderScan® compared with the gold standard of transurethral catheterization. RESULTS: Data of 407 patients was used for final analysis. Median PVRV as measured by BladderScan® was 380 ml (± 261-0-999 ml) and by catheterization was 375 ml (± 315-1800 ml). Mean difference between measurements was -12.9 ml (± 178 ml). There was a very good correlation between methods (Spearman's rho = 0.82, p < 0.001). Using a cut-ff value of >500 ml, specificity and sensitivity were 85.4 and 85.6%, respectively. CONCLUSIONS: The BladderScan® (BVI 9400) measures PVRV precisely and reliably after vaginal delivery and should be preferred over catheterization.

Long-term micturition problems of asymptomatic postpartum urinary retention: a prospective case-control study.

INTRODUCTION AND HYPOTHESIS: Covert (asymptomatic) postpartum urinary retention (PUR) is defined as post-void residual volume (PVRV) ≥150 mL. Although often supposed to be a common and harmless phenomenon, no data are available on the potential long-term micturition problems of increased PVRV after vaginal delivery. METHODS: After the first spontaneous void post-vaginal delivery, PVRV was measured using a portable scanning device. Micturition symptoms were compared using validated questionnaires between women with PVRV < 150 mL and those with PVRV ≥150 mL until 1 year after delivery. Women with PVRV ≥ 150 mL were followed until complete bladder emptying was achieved. RESULTS: Data of 105 patients with PVRV < 150 mL and 119 with PVRV ≥ 150 mL were available for analysis. 75% of all patients included had PVRV ≥ 250 mL. More primiparous patients had PVRV ≥ 150 mL (p < 0.02). 92% of women with PVRV ≥ 150 mL after delivery were able to adequately empty their bladder within 4 days. One year after delivery, no statistically significant differences were found. CONCLUSIONS: Covert PUR according to the definition of PVRV ≥ 150 mL, is a common and transient phenomenon that does not result in more lower urinary tract symptoms 1 year after delivery. Although the current definition is not useful in identifying postpartum women with a pathological condition, we suggest that the definition of covert PUR should be change to: "PVRV≥500 mL after the first spontaneous void after (vaginal) delivery." This cut-off value is the value at which some women do need more time to normalise emptying of the bladder. The exact clinical implications of covert PUR need to be further studied in this subcategory of women.

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

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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 PUR.

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.

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

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.

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 plication.