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.

Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial).

OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.

Postoperative Acute Angle-Closure Glaucoma: A Rare but Serious Complication: A Case Report.

Acute angle-closure glaucoma is a rare complication of general anesthesia. If not treated in time, acute angle-closure glaucoma can potentially cause permanent loss of vision. Physicians should therefore be vigilant for the possibility of acute angle-closure glaucoma in patients who experience postoperative change or loss of vision. Recently, some reported a case of bilateral acute angle-closure glaucoma after general anesthesia, in which the use of ephedrine was a possible trigger. This report begins by examining a case of unilateral acute angle-closure glaucoma. The potential triggers of this complication are discussed. This article concludes with a flowchart to aid anesthesiologists to accurately diagnose postoperative ophthalmic pathology.

Validation of a Model Predicting De Novo Stress Urinary Incontinence in Women Undergoing Pelvic Organ Prolapse Surgery.

OBJECTIVE: To validate a previously developed prediction model for de novo stress urinary incontinence (SUI) after undergoing vaginal surgery for pelvic organ prolapse (POP). METHODS: Model performance was determined using a cohort of women who participated in two, 14-center randomized trials in the Netherlands that evaluated whether postoperative SUI 1 year after surgery was reduced with or without concomitant midurethral sling at the time of surgery for symptomatic women who had at least stage 2 POP. Age, number of previous vaginal births, urine leakage associated with urgency, history of diabetes, body mass index, preoperative stress test result, and placement of a midurethral sling were used to calculate the predicted probability of an individual developing de novo SUI. Predicted probabilities were compared with outcomes and quantitated using the concordance index and calibration curves. Model accuracy was compared with and without the preoperative stress test, and net reclassification improvement was measured using probability cutoffs of 0.2, 0.3, and 0.4. RESULTS: Of 239 participants who did not report preoperative SUI and underwent surgery, 152 were eligible for analysis with complete baseline and outcome data. Model discrimination was acceptable and consistent with performance in the original development cohort when the preoperative stress test result was included (concordance index 0.63; 95% CI 0.52-0.74) and had lower discrimination than when the stress test variable was not included (concordance index 0.57; 95% CI 0.46-0.67, P=.048). The model that included the stress test variable was most accurate when predicted probabilities of de novo SUI were between 0 and 50%, and it correctly reclassified upward 5.9% (95% CI -14.8 to 26.8) of participants with de novo SUI and correctly reclassified downward 16.9% (95% CI 6.6-27.7) of participants without de novo SUI. CONCLUSION: On external validation, the model was predictive of de novo SUI after vaginal prolapse surgery and may facilitate decision making regarding concomitant sling placement. CLINICAL TRIAL REGISTRATION: Nederlands Trial Register, NTRR 1197 en 1070.

Stress urinary incontinence after vaginal prolapse repair: development and internal validation of a prediction model with and without the stress test.

OBJECTIVE: To develop a prediction model for stress urinary incontinence (SUI) after vaginal prolapse repair (postoperative stress urinary incontinence [POSUI]) and assess the value of a preoperative stress test. PATIENTS AND METHODS: Secondary analysis of two trials in which women were randomised for prolapse repair with or without a midurethral sling (MUS). The trials included women with (CUPIDO-1, n = 134) and without (CUPIDO-2, n = 225) coexisting SUI. POSUI was defined as bothersome SUI one year after surgery and/or treatment of SUI in the first postoperative year. Logistic regression analysis was used to define a reference model, which was extended with the preoperative stress test. The stress test was performed with and without reduction of the prolapse. Missing values were imputed 20 times, with bootstrap resampling for internal validation of discriminatory ability. RESULTS: Three hundred fifty-six women could be included. POSUI occurred in 17% of the women (n = 61). The reference model included age (<55 years), point Ba of the pelvic organ prolapse quantification system (<-1), vaginal parity (≤3), subjective urinary incontinence, and MUS. The stress test had an odds ratio of 2.4 (95% confidence interval [CI], 1.2-4.6) in the extended model, which increased the optimism-corrected area under the receiver-operating curve from 0.74 to 0.76. The stress test was especially valuable in women with a 10% to 30% POSUI risk, where a stress test substantially impacted the POSUI risk. In more than 50% of the women, the stress test had no additional value in predicting POSUI. CONCLUSION: A preoperative stress test is not valuable for women at low risk of SUI after vaginal prolapse repair.

Should we combine vaginal prolapse surgery with continence surgery?

The risk of postoperative stress urinary incontinence (SUI) can be reduced by combining prolapse repair with continence surgery. However, more women face a serious adverse event (SAE) after vaginal prolapse surgery combined with a midurethral sling (MUS). It is difficult to predict a woman's individual postoperative SUI and SAE risk; therefore, weighing the benefits and risks of combination surgery is complex. We offer a concept that might help in considering combination surgery. According to this concept, women whose risk of needing subsequent surgery for postoperative SUI is on average 9% are likely to benefit from combination surgery.

The predictive value of demonstrable stress incontinence during basic office evaluation and urodynamics in women without symptomatic urinary incontinence undergoing vaginal prolapse surgery.

AIMS: Women with pelvic organ prolapse without symptoms of urinary incontinence (UI) might demonstrate stress urinary incontinence (SUI) with or without prolapse reduction. We aimed to determine the value of demonstrable SUI during basic office evaluation or urodynamics in predicting SUI after vaginal prolapse repair in these women. METHODS: Women included in the CUPIDO trials without bothersome UI or UI more than once a week were eligible if they had undergone prolapse repair without incontinence surgery. The diagnostic and predictive value of demonstrable SUI was studied for postoperative SUI (POSUI). POSUI was defined as bothersome SUI at 1-year follow-up or treatment for SUI in the first postoperative year. RESULTS: In 45% (77/173) of the included women urodynamics was performed. In 19% (32/172) SUI was demonstrated with basic office evaluation, against 29% (22/77) with urodynamics. Nine percent (16/172) developed POSUI, six women underwent surgery for de novo SUI. Women with demonstrable SUI were more at risk to face POSUI: twenty-eight percent versus five percent (Diagnostic Odds Ratio: 7; 95%CI 3-22). Urodynamics predicted one more woman having POSUI, but all women who underwent treatment for de novo SUI showed SUI during basic office evaluation. Test performance did not improved with the adding of urodynamics. CONCLUSIONS: The predictive value of demonstrable SUI in symptomatically continent women undergoing vaginal prolapse repair is limited. Urodynamics added no value. The twenty-eight percent POSUI risk must be balanced against the increased complication risk if a prophylactic midurethral sling is considered.

Risks and benefits of the skin-to-skin cesarean section - a retrospective cohort study.

OBJECTIVE: Comparing maternal and neonatal outcomes after conventional cesarean section (CS) versus a "natural" or "skin-to-skin" cesarean section (SSCS). METHODS: Retrospective cohort of women who underwent a SSCS (01-2013 until 12-2013) compared to conventional CS (08-2011 to 08-2012). CS before 37 weeks, under general anesthesia and in case of fetal distress were excluded. Main outcome measures were maternal blood loss, post-operative infection and admission; neonatal infection and admission; procedural outcomes. RESULTS: We analyzed 285 (44%) women in the SSCS-group and 365 (56%) in the conventional CS-group. There were no significant differences in surgical site infection (2.1% versus 1.6%; RR 1.1; 95%CI 0.64-2.0), or other maternal outcomes. Fewer neonates born after SSCS were admitted to the pediatric ward (9.5% versus 18%; RR 0.58; 95%CI 0.41-0.80) and fewer neonates had a suspected neonatal infection (2.0% versus 7.3%; RR 0.40; 95%CI 0.19-0.83). No differences were observed for other outcomes. Mean operation time was 4m42s longer in the SSCS-group compared to the conventional CS-group (58m versus 53m; 95%CI 2m44s-6m40s). Mean recovery time was 14m46s shorter (114m versus 129m; 95%CI 3m20s-26m). CONCLUSION: Adverse maternal and neonatal outcomes were not increased after skin-to-skin cesarean compared to conventional cesarean delivery.

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.

Time efficiency of a web-based questionnaire in urogynecology: a randomized study.

INTRODUCTION AND HYPOTHESIS: Based on nationwide recommended questionnaires for women with pelvic floor dysfunction (PFD), we developed a web-based questionnaire (WBQ) that can be sent to women prior to their first visit. We hypothesized that using this WBQ would contribute to a more efficient first visit. Furthermore, we were interested in the satisfaction of patients who used the WBQ. METHODS: Women referred for PFD were randomized between WBQ and no questionnaire. Time spent per consultation was recorded in total and in split times for history taking, physical examination, counseling, and administration. Patient experience was evaluated by a standardized telephone interview. RESULTS: One hundred and twenty-eight women were randomized: 64 in the WBQ group and 64 in the control group. History taking was significantly shorter in the WBQ group [mean difference (MD) -1 m 32 s; 95 % confidence interval (CI) -2:41 to -0:23], and time for counseling was significantly longer (MD 1 m 21 s; 95 % CI 0:06-2:37). Overall time of the consultation was equal. The need for an additional visit tended to be less frequent in the WBQ group [53 % versus 64 %; relative risk (RR) 1.3, 95 % CI 0.8-2.0]. Forty-nine percent of women considered the WBQ time consuming without adding value. CONCLUSIONS: The WBQ contributed to a slightly more efficient use of the first consultation. While differences were small and patient satisfaction was low, other benefits of the WBQ should define whether the WBQ will be introduced.

Surgery versus physiotherapy for stress urinary incontinence.

BACKGROUND: Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. METHODS: We performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. RESULTS: We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery. CONCLUSIONS: For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.).

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial.

BACKGROUND: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. METHODS/DESIGN: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. DISCUSSION: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. TRIAL REGISTRATION: Dutch Trial Register: NTR3110.