The Impact of Vaginal Probiotics on Pessary Use: A Randomized Controlled Trial.

IMPORTANCE: Pessary-related adverse effects are common, and treatment options are limited. Probiotics may improve pessary-related adverse effects by altering the vaginal microenvironment. OBJECTIVE: This study aimed to evaluate the effect of a vaginal probiotic suppository on the vaginal microenvironment among pessary users. STUDY DESIGN: Women who used pessaries were randomized to vaginal probiotic suppository use versus without use. The intervention was a vaginal probiotic suppository and moisturizing vaginal gel. The vaginal microenvironment was assessed using Gram stain and Nugent's criteria at baseline and 3 months by a microbiologist blinded to group allocation. Symptoms and experience with use of the probiotic were assessed using questionnaires. The primary outcome was change in lactobacilli count on Nugent subscore at 3 months. RESULTS: A total of 147 postmenopausal women were randomized (86 to the intervention arm and 61 to the control arm), and 124 (87.9%) presented for a 3-month follow-up. There was no difference between the arms in age, race, body mass index, and Charlson Comorbidity Index. A majority of participants had the pessary managed by the health care professional (intervention arm vs control arm, 46 [76.7%] vs 55 [68.8%]; P = 0.30). Composition of the vaginal microenvironment did not differ with or without probiotic treatment at 3 months. Bother from vaginal symptoms, including discharge, itching, and discomfort, did not differ between arms. Adverse effects from the intervention were minor, resolved with discontinuation, and occurred at 39.1%. CONCLUSION: Vaginal probiotic suppository use did not affect the composition of the vaginal microenvironment, patient satisfaction, or vaginal symptoms after 3 months of use in pessary users.

Host inflammatory response in women with vaginal epithelial abnormalities after pessary use.

BACKGROUND: Vaginal epithelial abnormalities (VEA) are a common complication associated with pessary use. The objective of this study was to determine if there is a host pro-inflammatory response associated with pessary use and VEA. METHODS: Patients wearing pessaries for at least two weeks for the management of pelvic organ prolapse and/or urinary incontinence were screened for eligibility. Vaginal swabs were collected from women with VEA (cases) and without VEA (controls). Cases were matched to controls in a 1:3 ratio. Cytokine analysis of the collected samples was performed using multiplex analysis to determine the concentrations of interleukin (IL)6, interferon alpha 2 (IFNα2), tumor necrosis factor alpha (TNFα) and IL1ß. A cross-sectional analysis was performed, comparing vaginal cytokine concentrations in women with and without VEA. RESULTS: We enrolled 211 patients in this analysis: 50 cases and 161 controls. The median concentrations (pg/mL) of the four cytokines for cases and controls respectively were; IL6: 6.7 (IQR <2.9 [the lower limit of detection, LLD]-14.2) and < 2.9 (LLD) (IQR <2.9 [LLD]-5.5), IFNα2: 8.2 (IQR 6.1-13.9) and 7.9 (IQR 3.9-13.6), TNFα: 15.2 (IQR 6.1-30.4) and 4.68 (IQR <2.3 [LLD]-16.3), IL1ß 195.7 (IQR 54.5-388.6) and 38.5 (IQR 6.7-154.9). The differences in median cytokine levels were statistically higher in cases for IL6, TNFα, and IL1ß (all p < 0.001) compared to controls. Older age (OR: 1.062, 95% CI, 1.015-1.112), lower BMI (OR: 0.910, 95% CI, 0.839-0.986) and presence of VEA at last check (OR: 5.377, 95% CI, 2.049-14.108) were associated with higher odds of having VEA on multivariate analysis. CONCLUSION: Pro-inflammatory cytokines, specifically IL6, TNFα, and IL1ß, are elevated in pessary-wearing patients who have VEA. Additional prospective studies are needed to assess baseline vaginal inflammatory profiles before and after pessary placement to understand VEA formation in pessary patients.

Timing of Office-Based Pessary Care: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the influence of pessary visit intervals on development of vaginal epithelial abnormalities. METHODS: We conducted a randomized, noninferiority trial of office-based pessary care. Eligible participants were adult women wearing a ring, Gellhorn, or incontinence dish pessary to treat pelvic organ prolapse or incontinence or both. Patients were randomized 1:1 to routine pessary care (office visits every 12 weeks, "routine" arm) or to extended pessary care (office visits every 24 weeks, "extended" arm). The primary study outcome was rate of vaginal epithelial abnormalities (epithelial break or erosion) at the final study visit (48 weeks). The predetermined noninferiority margin was 7.5%. RESULTS: From January 2015 through June 2017, inclusive, 448 patients were screened and 130 were randomized, 64 to the routine arm and 66 to the extended arm. Baseline characteristics of the study arms were similar with the exception of pessary type, with ring pessary more common in the routine arm and Gellhorn pessary more common in the extended arm (P=.02). The rate of epithelial abnormalities at the final study visit (48 weeks) was 7.4% in the routine arm and 1.7% in the extended arm (difference, -5.7 percentage points; 95% CI -7.4 to -4), which met the criterion for noninferiority. Rates of all types of epithelial abnormalities did not differ between arms at any time point. Increasing duration of pessary use (P=.003) and history of prior epithelial abnormalities were associated with development of epithelial abnormalities (P=.01). Other than epithelial abnormalities, no adverse events related to pessary use occurred in either arm. CONCLUSION: In women who receive office-based pessary care and are using a ring, Gellhorn, or incontinence dish pessary, routine follow-up every 24 weeks is noninferior to every 12 weeks based on incidence of vaginal epithelial abnormalities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02371083.

The effect of pessaries on the vaginal microenvironment.

OBJECTIVE: The objective of the study was to evaluate the differences in vaginal culture, microscopy, and Gram stain between postmenopausal women who wear pessaries and those who do not to explain pessary-related, bothersome vaginal discharge. STUDY DESIGN: Postmenopausal women not using exogenous estrogen who had either been wearing a pessary for at least 3 months or who were undergoing their first pessary fittings were approached for enrollment. Symptoms were assessed, and vaginal fluid was collected for culture, microscopy, and Gram stain. A cross-sectional analysis was performed, comparing the new and return pessary wearers. The new pessary users were also sampled at 2 weeks, 3 months, and 6 months after fitting. RESULTS: Women who wore pessaries were more likely to be bothered by discharge (30.0% vs 2.1%, P < .001). They were also more likely to show microscopic evidence of vaginal inflammation and vaginitis. Prospective data showed that these changes developed during the first 2 weeks of pessary use. Aerobic and anaerobic organisms were nearly identical in women with and without bothersome vaginal discharge in the cross-sectional analysis and at all time points in the prospective analysis. CONCLUSION: Pessary-related, bothersome vaginal discharge develops early and may be due to an inflammatory process in the vagina.

The impact of pessary use on bowel symptoms: one-year outcomes.

OBJECTIVES: The literature states that patients with pelvic organ prolapse have a higher prevalence of bothersome bowel symptoms and that surgical correction of prolapse may improve bowel function. There is limited knowledge regarding the impact of pessary use on bowel function in patients with prolapse. The aim of this study was to evaluate if there is a change in bowel symptoms in patients with prolapse treated with a vaginal pessary. METHODS: Women who presented for pessary insertion completed the validated questionnaires on the bowel symptom severity and on the effect of bowel symptoms on the quality of life at baseline and again at 12 months of continuous pessary use. Inferential statistics comprised Student t test for evaluating differences in continuous Gaussian data between groups and paired t tests were used to evaluate differences among subjects between the baseline and 12 months of use. RESULTS: One hundred four women participated in the original study, and 43 had complete data for analysis. Women who completed 12 months of pessary use reported significant improvements in both bowel-related symptoms and bowel-related quality of life (95% confidence interval of the difference 1.6-11.4 and 2.0-14.0, respectively). Patients who completed the 12-month follow-up were significantly older and more likely to have stage 3 or 4 prolapse than noncompleters, but there were no differences in body mass index, race, history of prior prolapse surgery, or menopause status. CONCLUSIONS: In women with prolapse, the use of a pessary is associated with a decrease in complaints related to bowel symptoms.

Pessary use and impact on quality of life and body image.

OBJECTIVES: : The objective of the study was to determine if vaginal pessaries improve symptoms of prolapse and body image in women with pelvic organ prolapse. Our hypothesis was that pessary use would improve prolapse-related symptoms and body image up to 1 year. METHODS: : Women presenting for pessary insertion completed questionnaires regarding pelvic floor-related symptoms and body image with successful pessary insertion and after 6 to 12 months of continued pessary use. Scores were compared with a paired t test. RESULTS: : Forty-three subjects had complete data for analysis. Scores on both prolapse-related and body image questionnaires showed improvements at 6 months (P < 0.001) and 12 months (P < 0.010). Younger women and those with prior prolapse surgery were less likely to continue to use a pessary past 3 to 6 months. Stage of prolapse, body mass index, and scores on symptom questionnaires did not correlate with likelihood of continued pessary use versus surgery. CONCLUSIONS: : The use of a pessary for more than 12 months improves symptoms of prolapse and self perception of body image.

Impact of pessary use on prolapse symptoms, quality of life, and body image.

OBJECTIVE: We sought to evaluate whether use of a vaginal pessary would change body image, bother symptoms, and quality of life in women with pelvic organ prolapse. STUDY DESIGN: Women presenting for pessary insertion completed the short forms of Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire, and Body Image Scale. After successful pessary insertion and use for at least 3 months, subjects completed the surveys again. Scores were compared with a paired t test. RESULTS: A total of 75 subjects were enrolled and follow-up responses were available for 54 subjects for analysis. Body Image Scale scores showed a significant decrease (6.1-3.4; P<.001), indicating an improvement in these women's perception of themselves, as did Pelvic Floor Distress Inventory-20 scores (81.34-45.83; P<.001) and Pelvic Floor Impact Questionnaire scores (50.32-17.98; P=.003). CONCLUSION: The use of a pessary for 3 months reduces bother symptoms and improves both quality of life and perception of body image in women.