The effect of 12 weeks of estriol cream on stress urinary incontinence post-menopause: A prospective multinational observational study.

OBJECTIVE: To quantitate the changes in stress urinary incontinence (SUI) outcome measures after 12 weeks of vaginal estriol cream in women with stress incontinence. METHODS: A prospective multicentre observational study conducted in tertiary urogynaecology centers. Postmenopausal women with pure SUI or stress predominant mixed urinary incontinence (MUI), not receiving any other treatment for their incontinence were given written instructions regarding digital application of a standard dose of vaginal estriol cream. Outcomes were measured at baseline and 12 weeks. The primary objective outcome was vaginal pH. The primary subjective outcome was the stress domain of the Urogenital Distress Inventory-6 (UDI-6). The secondary objective outcome used was the erect cough stress test. Two quality of life questionnaires and two patient reported outcomes were also included. RESULTS: The 46 postmenopausal recruits had a median age of 62.1 interquartile range (IQR 56.2-65.4). At follow up, the primary subjective outcome SUI domain [UDI-6] significantly improved from 83.3 (IQR 50-100) to 33.3 (33.3-66.7, p ≤ 0.001) as did vaginal pH [from 5.1 (4.9-5.9) to 4.9 (4.6-5.0] p ≤ 0.001; 18/43 patients (42%) were dry on cough stress test. CONCLUSIONS: Twelve weeks of vaginal estriol cream significantly reduced symptoms of stress urinary incontinence in this sample of postmenopausal women.

Efficacy and patient acceptability of the continence dish.

INTRODUCTION AND HYPOTHESIS: The continence dish has been a treatment option since 2002 for women with stress urinary incontinence (SUI) who decline surgery, but few quantitative objective efficacy data are published. We aimed to determine the efficacy and acceptability of this device for pure SUI or mixed incontinence (MUI). METHODS: Prospective interventional cohort study of 100 women with SUI or stress-predominant MUI who were interested to use the device; International Consultation on Incontinence Questionnaire (ICIQ) was primary outcome measure; 24-h pad test and Incontinence Impact Questionnaire (IIQ) were secondary outcomes. Acceptability was determined by device retention for 4 weeks, adverse events and ability to self-insert the device. RESULTS: Of 100 suitable women, 9 were not actually fitted, and 27 did not complete (acceptability: 64/100). The rate of adverse events was 7.7%, with 62.5% of users able to self-insert the device: 22 (34%) had pure SUI; 66% had MUI. In SUI, 68% were 'dry' on ICIQ median value 4.0 (IQR 2.5-8.5); 88% were dry on 24-h pad test (median 0.0, IQR 0.0-8.5). The "dry rate" was lower in MUI: 36% for ICIQ (median 9.0, IQR 5.0-15.0) and 62% for 24-h pad test (median 6.2, IQR 0.95-19.7). A "good" response on IIQ occurred in 88% of SUI and 69% of MUI. CONCLUSION: These new data showing strong objective benefits of the continence dish should be further validated by randomized trials, but this information should be made available to women seeking treatment options for SUI/MUI (particularly in view of concerns regarding mesh mid-urethral slings).

Effect of antibiotics on urine leakage in women with refractory detrusor overactivity: A phase IIb randomized trial.

AIM: Because bacterial cystitis is common in women with refractory detrusor overactivity, the aim was to compare the efficacy of 6 weeks of rotating antibiotics versus placebo, in conjunction with an anticholinergic, in controlling the symptoms of urge incontinence. METHODS: In a multicenter phase IIb double-blinded randomized placebo-controlled trial, women with urodynamically proven refractory detrusor overactivity were randomized in a 2:1 ratio of antibiotics versus placebo for 6 weeks, in addition to darifenacin for 6 months. Any woman with disabling cystitis symptoms was given appropriate antibiotics ("clinical override"). The primary outcome was the degree of urge incontinence change at 6 weeks and 6 months on 24-h pad test. Secondary outcomes were changes in leaks and voids per day measured on 3-day bladder diary and quality of life measures. Microbiological data were collected at all visits. RESULTS: Although 278 women were screened, only 36 were randomized and 33 (91.7%) completed the trial. Leakage on 24-h pad test decreased at 6 months by 75 g in patients receiving antibiotics versus 35 g in placebo. Cure of urge incontinence occurred at 6 months in 10/21 (48%) of antibiotics versus 2/12 (17%) of placebo. Clinical override, necessitating treatment of cystitis, occurred in 41.6% of placebo versus 16.7% of the antibiotic group by 6 months. CONCLUSION: Despite the small sample size, the study showed a significant reduction in pad leakage and leaks per day over 24 h in the active treatment group over a 6-month period. Nearly half of patients on placebo had disabling urinary tract infection symptoms that required clinical override treatment.

Postpartum anal incontinence in women with and without obstetric anal sphincter injuries.

INTRODUCTION AND HYPOTHESIS: Postpartum anal incontinence is common and distressing for women. We sought to look at the prevalence of anal incontinence in women who sustained obstetric anal sphincter injuries (OASI) compared with women who did not, and factors leading to these symptoms during the postpartum period. METHODS: A total of 129 primiparous women sustaining OASI were compared with 131 women who did not (controls). They were contacted at approximately 6-10 weeks postpartum to obtain information on their symptoms of anal incontinence (AI). The data underwent univariate and multivariate analysis. RESULTS: There was no difference in the prevalence of AI symptoms, occurring in 30% of women with OASI, and 23% of women without at 6-10 weeks postpartum; however, in women with high-grade tears the prevalence was 59%. Severe OASI (grade 3c and 4) was associated with an increased prevalence of both AI and severe AI, whereas forceps delivery and increasing maternal age were associated with an increased prevalence of severe AI only. CONCLUSION: Women with less severe (grade 3a and 3b) OASI do not experience a higher prevalence of AI than women without OASI in the postpartum period. Higher grade (3c and 4) tears, forceps delivery and increasing maternal age are associated with higher rates of AI. These factors should be avoided where possible to reduce postpartum AI. All women should be warned of the 23-30% chance of experiencing some mild AI in this period. Whether these symptoms are transient or long-lasting requires further investigation.

The relationship between residual sphincter damage after primary repair, faecal incontinence, and anal sphincter function in primiparous women with an obstetric anal sphincter injury.

BACKGROUND AND AIMS: Anal sphincter injury has been identified as a primary cause of post-partum fecal incontinence in women with obstetric anal sphincter injury. However, women without obstetric anal sphincter injury may also develop fecal incontinence. The aim is to determine the relationship between fecal incontinence severity; and i) residual anal sphincter injury, quantified by the Starck score, and ii) anal sphincter tone. METHODS: Consecutive case series of prospectively collected data set in a Pelvic Floor Unit within a tertiary teaching hospital in Australia. Population 181 primiparous women with Sultan classification Grade 3 and 4 sphincter injuries. MAIN OUTCOME MEASURES: Sultan classification, anal manometry, pudendal nerve terminal motor latency, St Mark's fecal incontinence score, and Starck ultrasound score. RESULTS: 45% of women reported some degree of fecal incontinence. One third of women with normal external sphincter tone were incontinent. Those with higher Starck score had higher St Mark's scores. A higher Sultan classification correlated with more severe incontinence regardless if the repair was complete. Forceps delivery had a twofold risk of incontinence when compared to non-forceps delivery. CONCLUSION: The importance of an effective anal sphincter repair is confirmed. However, overall there is no direct relationship between residual sphincter damage, anal sphincter tone, and fecal incontinence severity. These data indicate that anal sphincter integrity alone is not the sole mechanism for maintaining fecal continence. Rectal and colonic motor function may also play a role and investigation into these components may provide greater insight into the effect of vaginal delivery upon fecal continence mechanisms.

A prospective "bottom up" study of the costs of faecal incontinence in ambulatory patients.

BACKGROUND AND AIM: The few studies that have examined direct costs of faecal incontinence are limited in that they employed retrospective databases, postal surveys, and focused upon institutionalised patients or post partum women. The aim of the current study was to identify the direct pre-treatment costs of faecal incontinence expended by a range of home dwelling patients and identify relationships between costs and severity of incontinence. METHODS: Consecutive patients attending an outpatient clinic for treatment of faecal incontinence were interviewed using a questionnaire, modeled on the Dowel Bryant Incontinence Cost Index. The information collected included costs of: (i) basic personal hygiene: pads, laundry, wipes, cleansers; (ii) medication: loperamide, creams and stool bulking agents; and (iii) diagnostic: medical attendance, anorectal physiology, colonoscopy. Costs were broken down into personal expenses, government costs, and costs to health funds. A St Mark's Faecal Incontinence Severity Score was recorded. RESULTS: A total of 100 consecutive patients consented (15 males, 85 females) mean age 70.8 (SD12) years. Mean St Mark's score was 12 (SD4.5). The median total patient cost was $437.72 AUD (range 0-2807) per annum. Government costs were $537AUD (range 135-1657), and health fund median $0 AUD (0-1628). Incontinence severity correlated with personal expense only median $283.75AUD (range 0-2350). The aged were more incontinent but costs did not increase in relation to age. CONCLUSION: Faecal incontinence results in a substantial financial burden for both patients and Government. Effective treatments which relieve the financial burden of faecal incontinence, are likely to be economically advantageous into the future for both patients and Government.

Vascular measures of atherosclerosis in detrusor overactivity and controls.

AIM: The mechanisms leading to the development of detrusor overactivity (DO) are still relatively poorly understood, however, animal studies suggest that atherosclerosis and reduced blood flow to the bladder may be one etiological pathway. Thus, the aim of this study was to evaluate signs of atherosclerosis in a large cohort of women with detrusor overactivity, using two precise measures of atherosclerotic vascular impairment, Ankle Brachial Index (ABI), and Brachial-ankle Pulse Wave Velocity (baPWV). METHODS: A prospective cohort study measuring ABI and baPWV of women with DO and controls was conducted. The ABI and baPWV were measured using an automated oscillometric blood pressure machine, to evaluate the degree of atherosclerosis in patients with DO and controls. Associations between ABI and baPWV and important confounding variables were assessed by a linear regression model. RESULTS: Ninety-eight women with DO, and 98 controls without any symptoms of DO were studied. Multivariate analysis showed an increase in left baPWV of approximately 96 cm/s units of velocity (95%CI 20.65-172.05, P = 0.01) is predicted significantly by the presence or absence of detrusor overactivity (as well by independent factors of age, diastolic blood pressure and body mass index). A similar effect was seen for right baPWV. CONCLUSIONS: On linear regression modeling, the presence of DO was a strong predictor for an increased PWV when controlling for age, BMI and diastolic blood pressure (DBP), thus supporting the hypothesis that atherosclerosis may contribute to the etiology of DO.

Does motivation predict outcome of pelvic floor muscle retraining?

AIMS: Although pelvic floor muscle training (PFMT) is effective for stress urinary incontinence (SUI), patients need to be motivated to obtain cure. An instrument to assess motivation in such patients was published in 2009: the Incontinence Treatment Motivation Questionnaire (ITMQ). The ITMQ consists of five domains: (i) positive attitudes toward PFMT; (ii) reasons for not doing PFMT; (iii) difficulties living with incontinence; (iv) desire for treatment; and (v) incontinence severity influencing motivation. The aim of the present study was to examine the relationship between ITMQ scores and treatment success. METHODS: After referral for PFMT, women with SUI completed the ITMQ. Pre- and post-treatment outcomes were the International Consultation on Incontinence Questionnaire (ICIQ) score and a 24-hr pad test. Correlations between ITMQ scores and baseline, as well as post-treatment change in ICIQ scores and pad test results were examined. Additionally, the demographics of non-participants, participants, and patients lost to follow-up were compared. RESULTS: Of 85 recruits, 18 did not complete the ITMQ, 14 were lost to follow-up, thus 53 completed the PFMT programme and undertook either one or both outcomes. Pre-treatment, severity on ICIQ correlated with total ITMQ (ρ = 0.33, P = 0.01). Post-treatment change in pad test was inversely correlated with Domain 2 (ρ = -0.33, P = 0.03). CONCLUSIONS: The pre-treatment severity of incontinence was significantly associated with motivation for treatment. Unfortunately, post-treatment change correlated with only one domain of the questionnaire. Further modification of the ITMQ is envisaged. Neurourol. Urodynam. 36:316-321, 2017. © 2015 Wiley Periodicals, Inc.

Objective efficacy of the tension-free vaginal tape in obese/morbidly obese women versus non-obese women, at median five year follow up.

BACKGROUND: One subjective long-term evaluation of the tension-free vaginal tape (TVT) success rate in obese women showed a worse prognosis in the obese, but objective studies have been limited to short-term follow-up (less than two years). AIM: To determine whether the long-term objective cure rate in obese/morbidly obese women who underwent TVT was reduced, compared to non-obese women (at five or more years). MATERIALS AND METHODS: Body mass index (BMI) was collected on patients undergoing TVT procedure. Recruited patients were asked to perform a 24 h pad test and complete an International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) at five years postoperatively. Data was analyzed according to pre-operative urodynamic diagnoses and BMI, using 'routine' and 'strict' objective definitions of objective cure. RESULTS: At median follow-up of 64 months (interquartile range 58-80 months), 136 patients returned a pad test and ICIQ-SF. Using a routine definition of cure (pad test of ≤10 g in a 24 h period), 96% of patients were cured overall. The BMI results (n = 119 patients) were stratified into ≤25, 25.1-35 and ≥35.1 kg/m2 , which represented 41, 53 and 6% of patients, respectively. The routine cure rates for these three groups were 98, 97 and 71%, respectively (P = 0.004). CONCLUSION: Long-term objective outcomes of the TVT in morbidly obese women are significantly poorer than in women with a normal BMI.

Risk factors for obstetric anal sphincter injuries and postpartum anal and urinary incontinence: a case-control trial.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) cause serious maternal morbidity for mothers. A clearer understanding of aetiological factors is needed. We aimed to determine the risk factors for OASIS . METHODS: Birth details of 222 primiparous women sustaining OASIS were compared with 174 women who did not sustain OASIS (controls) to determine the relevant risk factors. The data underwent univariate analysis and logistic regression analysis. RESULTS: Asian or Indian ethnicity, operative vaginal birth (p = 0.00), persistent occipito-posterior position (p = 0.038) and rapid uncontrolled delivery of the head were identified as risk factors for OASIS. Pushing time, use of epidural, episiotomy and head circumference were not predictors of OASIS. CONCLUSIONS: Women with Asian or Indian ethnicity, operative vaginal birth, persistent occipito-posterior position and rapid uncontrolled delivery of the fetal head were likely to sustain OASIS. Awareness of these factors may help to minimise the incidence of OASIS.

Decreased intravesical adenosine triphosphate in patients with refractory detrusor overactivity and bacteriuria.

PURPOSE: Although several studies have examined the relationship between adenosine triphosphate release from the urothelium and bladder sensations including painful filling and urgency, the association between bacteriuria and urothelial adenosine triphosphate release has not been well studied. We evaluated women with refractory detrusor overactivity who were experiencing an acute exacerbation of detrusor overactivity symptoms including frequency, urgency and nocturia (and/or urge incontinence). We measured changes in intravesical adenosine triphosphate levels in these women with and without bacteriuria. MATERIALS AND METHODS: In this prospective cohort study women with refractory detrusor overactivity were invited to our unit during acute symptomatic exacerbation. On presentation a catheter urine specimen was collected and 50 ml normal saline instilled into the bladder to evoke gentle stretch, with removal after 5 minutes. Adenosine triphosphate concentrations were determined on fresh washings using a bioluminescence assay. RESULTS: The incidence of bacteriuria 10(3) cfu/ml or greater was 27% (15 of 56 specimens) during the 16-month study period. Adenosine triphosphate concentrations were lower during episodes of bacteriuria in the overall cohort (p = 0.0013) and paired samples from individual patients (p = 0.031) compared to episodes of sterile urine. CONCLUSIONS: In the first study on the subject to our knowledge, we demonstrated a striking difference between adenosine triphosphate levels measured in the presence and absence of bacteriuria in this patient group.

Does monthly self-management of vaginal ring pessaries reduce the rate of adverse events? A clinical audit.

Objective: To determine the rate of adverse events (AE) in women who self-manage their vaginal ring pessary on a monthly basis. We hypothesised that the AE rate would be lower compared to previously published traditional management protocols. Study design: Audit study of 75 women with pelvic organ prolapse and/or stress incontinence, who were fitted with a vaginal ring pessary during a five-year period, and who have self-managed their vaginal rings for at least two years, in a tertiary referral urogynaecology clinic. Main outcome measures: AEs included vaginal bleeding, malodorous vaginal discharge, extrusion of the device, pain/discomfort, and disorders of defaecation or de novo urinary incontinence. AEs that led to discontinuation of usage were termed "major". Results: Of the 75 women who were taught to self-manage their ring pessary, 68 were initially successful. At a median follow-up of 50.5 months [IQR 43-76 months; median 4.2 years], 36 women (52.9%) were still using their ring pessary. Five women (7.4%) had vaginal erosions and bleeding leading them to cease pessary use (four proceeded to surgery). Three minor AEs were identified (4.4%), resolving after discontinuation of ring use two weeks. Thus, the overall AE rate was 11.8% (8/68). Conclusions: In contrast to previous published AE rates of 43-56% in women having ring changes at a clinic every 4-6 months, the AE rate was 12% in the women who performed monthly self-management of vaginal ring pessaries. Such information should be made available to patients considering a vaginal ring pessary.

Prevalence of "low-count" bacteriuria in female urinary incontinence versus continent female controls: a cross-sectional study.

INTRODUCTION AND HYPOTHESIS: Older studies suggesting an association between detrusor overactivity and bacteriuria used an outdated microbiological threshold. We hypothesised that bacteriuria ≥10(3) CFU/ml would be more prevalent in women with urinary incontinence than continent controls. METHODS: A prospective, cross-sectional study of prevalence of bacteriuria ≥10(3) colony-forming units (CFU)/ml on catheter specimens. Sample estimates suggested 62 women per arm would yield 80% power. Multivariate regression analysis was performed using risk factors including, age, diabetes, menopausal status, sexual activity and cystocele. RESULTS: Among 213 participants, bacteriuria ≥10(3) CFU/ml was more prevalent in incontinent women than continent controls (odds ratio [OR] 4.06; p = 0.036). Two thirds of bacteriuric specimens grew "low-count" bacteriuria. On multivariate analysis, only cystocele ≥ grade II was independently associated with bacteriuria (p = 0.025). On sub-analysis by diagnosis, the only significant finding was with bladder oversensitivity (OR 13.8; p = 0.0017). CONCLUSIONS: Bacteriuria, including "low-count" bacteriuria, is more prevalent in urinary incontinence when compared to continent female controls.