Prevalence and Quality of Life among Overweight and Obese Women with Different Severity and Types of Urinary Incontinence.

OBJECTIVE: Urinary incontinence (UI) is an involuntary leakage of urine and affects the social, physical, and psychological aspects of many individuals worldwide. The purpose of our study was to examine the prevalence, quality of life (QoL), severity, and different types of UI in overweight and obese women. METHODS: We conducted a cross-sectional study of 1,351 consecutive patients, who were recruited between June 2021 and May 2022. RESULTS: The mean age of the patients was 39.7 ± 14.2 years with less than a half in the 19-35-year age group (46.9%); 65% of the subjects were overweight or obese. The overall prevalence of UI was 61.2%. Overweight and obesity accounted to 70.2% of patients with mild to very severe UI. The risk estimates to have UI were 1.84 in overweight and 5.4 in obese group. The risk estimate for severe and very severe UI was 2.33 in overweight and 10.34 in obese group. When considering all subtypes, 67.9% of women with overweight and obesity had any of the subtypes, urge UI, stress UI, and mixed UI. Overweight and obesity were significantly associated with poor QoL in women with UI (p < 0.0001). Among 36.1% of all patients with poor QoL, 79.9% were overweight and obese. CONCLUSIONS: Overweight and obesity are important risk factors of UI affecting daily activity and QOL considerably. As the number of people with obesity is increasing, the prevalence of UI with increased severity is likely to increase in young to mid-aged women. Weight loss should be considered as first-line treatment for this patient population.

Psychosocial functioning of women suffering from stress and mixed form of urinary incontinence depending on the severity of the symptoms.

INTRODUCTION: Urinary incontinence is a troublesome symptom that negatively affects many aspects of life among woman suffering from this disease. It disturbs social, professional and intimate relations, and thus contributes to a negative self-image, loss of self-confidence, withdrawal of a woman from social and family life, and consequently promotes negative state of mind and depression. AIM: The aim of the study was to analyse the influence of urinary incontinence on the psychosocial functioning of women suffering from this disease. MATERIAL AND METHODS: The study included a group of 202 women aged 40.1 ± 13.9 years. A proprietary questionnaire was used, aimed at all women who had an episode of urinary incontinence at any time in their life. RESULTS: The impact and perception of the urinary incontinence symptoms depended on its form and severity. Comparing stress urinary incontinence with the mixed form, a greater severity of symptoms in women with the mixed form were observed, respectively 13.6% vs. 53.9%. Taking into account the aspects of life affected by urinary incontinence, it was found that the greatest impact UI had on the social (52.5%), then on the professional (28.7%), and the least impact on the family aspect of life (21.8%). CONCLUSIONS: Research has shown that urinary incontinence has the greatest impact on the social aspect of the surveyed women's life. The reported impact largely depended on the form and severity of urinary incontinence. In over 40% of women, symptoms related to urinary incontinence caused a deterioration of wellbeing and body acceptance. The mixed form was by far the most problematic and had the greatest impact on the daily functioning of women compared to, for example, the stress form.

Predictors of Regret among Older Men after Stress Urinary Incontinence Treatment Decisions.

PURPOSE: When seeking treatment for male stress urinary incontinence (mSUI), patients are faced with weighing complex risks and benefits in making treatment decisions within their individual context. We sought to quantify the frequency of decisional regret among this population and to determine factors associated with regret. MATERIALS AND METHODS: A cohort of 130 males aged ≥65 years seen for initial mSUI consultation at the University of California, San Francisco Medical Center and the San Francisco Veterans Affairs Medical Center between June 2015 and March 2020 was developed. Using retrospective chart review and telephone interviews, we ascertained decisional regret as well as other patient-, disease- and treatment-related characteristics. Decisional regret was analyzed by treatment type and patient-, disease- and treatment-related factors. Multivariable logistic regression models were built to examine the factors most associated with decisional regret. RESULTS: Among the entire cohort, 22% reported moderate to severe decisional regret. Regret was highest among those electing conservative management, with 34.7% having decisional regret (vs with surgery: 8.3% sling, 8.2% sphincter; p <0.001). In multivariable analysis, depression, lower rating of shared decision making and higher current incontinence scores were significantly associated with decisional regret. CONCLUSIONS: Recognition of depression, improved efforts at shared decision making and more individualized treatment counseling have the potential to improve patient satisfaction with treatment choice. In addition, given high levels of regret among those electing conservative treatment, we may be underutilizing mSUI surgery in this population.

The Effect of Electrical Stimulation Therapy With Pelvic Floor Muscle Exercise on Stress Urinary Incontinence in Middle-Aged Women: A Nonequivalent Comparison Cohort Study.

PURPOSE: The purpose of this study was to evaluate the effects of combined pelvic floor muscle exercises (PFMEs) and a novel electrical stimulation (ES) device versus PFMEs alone on lower urinary tract symptoms, urinary incontinence-related quality of life, and pelvic floor muscle contractions (PFMCs). DESIGN: Nonrandomized comparison cohort study. SUBJECTS AND SETTING: The sample comprised 54 community-dwelling middle-aged women with stress urinary incontinence recruited from churches and cultural centers in Gyeonggi Province, South Korea. Comparisons of demographic and pertinent clinical characteristics revealed no significant differences between the experimental and comparison groups. METHODS: Participants allocated to the combined intervention group (n = 27) performed self-exercises of the pelvic floor muscles 3 times a day under weekly telephone coaching, and they used the ES device twice daily for 8 weeks. Participants in the comparison group (n = 27) received the PFMEs alone without telephone coaching. The 3 main outcomes including lower urinary tract symptoms, urinary incontinence-related quality of life, and PFMCs were measured using the Bristol Female Lower Urinary Tract Symptom instrument (BFLUTS), King's Health Questionnaire (KHQ), and a perineometer, respectively. Study outcomes were measured at baseline and at the end of the 8-week period. RESULTS: Participants in the experimental group achieved significantly greater reductions in lower urinary tract symptoms (t = -4.07, P < .001) and improvement in urinary incontinence-related quality of life (P = .006), peak PFMC pressure (P = .004), mean pelvic muscle contraction (PMC) pressure (P < .001), and duration of PFMCs (P < .001) when compared to participants undergoing PFMEs alone. CONCLUSIONS: Combined ES and pelvic floor exercise was more effective in reducing severity of lower urinary tract symptoms, enhancing health-related quality of life, and increasing PMC pressure in middle-aged women with stress urinary incontinence than PFMEs alone.

Women's Experience with Stress Urinary Incontinence: Insights from Social Media Analytics.

PURPOSE: We conducted a large-scale digital ethnographic analysis of anonymous online posts to capture the complete patient experience, knowledge and perceptions among women with stress urinary incontinence. MATERIALS AND METHODS: Online posts were identified through data mining. Overall, 200 randomized posts were analyzed using grounded theory qualitative methods. To ensure full thematic discovery we also applied a Latent Dirichlet Allocation probabilistic topic modeling approach to the entire data set of identified posts. Latent Dirichlet Allocation topics are represented as a distribution of words, similar to a word cloud, which were manually reviewed to identify themes. RESULTS: A total of 985 online posts by 762 unique users were extracted from 98 websites. There was significant overlap between the grounded theory and Latent Dirichlet Allocation identified themes. Our analysis suggests that these online communities help women manage the quality of life impact of their stress urinary incontinence, navigate specialty care and reach a decision regarding surgical vs nonsurgical management. Additionally, we identified risk factors, prevention strategies and treatment recommendations discussed online. CONCLUSIONS: Findings demonstrated patient values that may influence decision making when seeking care for stress urinary incontinence and choosing a treatment. Social media interactions provide insight into patient behaviors that are important in order to improve patient centered care and decision making.

Factors involved in the persistence of stress urinary incontinence from postpartum to 12 years after first delivery.

AIMS: The aim of this study was to investigate constitutional-, pregnancy-, labor-, and delivery-related factors involved in the long-term persistence of stress urinary incontinence (SUI) from 6 months postpartum to 12 years after first delivery. We also evaluated severity and impact on quality of life of persistent SUI. METHODS: This was a longitudinal study including primigravid women who gave birth at our Public Health Hospital during 2007. Urinary symptoms were investigated at inclusion, 6 months and 12 years after delivery. Persistent SUI was defined as SUI reported both at 6 months postpartum and 12 years after first delivery. The International Consultation on Incontinence-Urinary Incontinence-Short Form (ICIQ-UI-SF) and the Incontinence Severity Index (ISI) were used to evaluate SUI. RESULTS: During the inclusion period, 479 pregnant women were interviewed, 381 attended the 6-month follow-up visit, and 315 formed the study group. SUI persisted in 36 out of 44 (81.8%) women. With the ISI, 52.8% of these women were categorized as having slight, 41.7% moderate, and 5.6% severe incontinence. The mean ICIQ-UI-SF score was 7.13 (SD 3.51). Pregnancy SUI (odds ratio [OR], 4.54; 95% confidence interval [CI], 2.10-9.80) and active second stage of labor more than or equal to 1 hour (OR, 3.68; 95% CI, 1.21-11.14) were independently associated with persistent SUI. CONCLUSIONS: Women who reported SUI during pregnancy, and those who had pushed for more than or equal to 1 hour in the second stage of labor were at greater risk of SUI persisting from 6 months postpartum to long after delivery. We found this independent association after controlling for several constitutional-, pregnancy-, labor-, and delivery-related variables.

Effects of individual pelvic floor muscle training vs individual training progressing to group training vs group training alone in women with stress urinary incontinence: A randomized clinical trial.

AIMS: To assess the effects of individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training in women with stress urinary incontinence (SUI). METHODS: Randomized controlled and pragmatic clinical trials with 90 women with SUI. Participants were randomly allocated to one of three groups: IT, GT, or four individual sessions progressing to group training (IPGT). The intervention included 12 sessions, once a week, with direct supervision by a physical therapist. PRIMARY OUTCOME: severity according to the King's Health Questionnaire. SECONDARY OUTCOMES: PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy. Reassessments were conducted at the end of the intervention, 3 and 6 months after the intervention. Intra- and intergroup analysis for all outcomes was performed using a multivariate analysis of variance. In the mixed-effects model used, the evaluation groups and times and their interactions were considered. A significance level of 5% was adopted. RESULTS: After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56). The benefits of the intervention were maintained 3 and 6 months after the end of the supervised training (P < .001). The IPGT group had a significant improvement in PFM function when compared to the other groups posttreatment (P < .001). CONCLUSION: PFM training improved the severity of urinary incontinence in all groups after 12 sessions of training supervised by a physical therapist. IT progressing to GT improved the function of upper PFM when compared to the other groups.

What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling.

BACKGROUND: Stress urinary incontinence (SUI) is a major component of the post radical prostatectomy (RP) trifecta. Surgical treatments are sub-urethral slings, artificial urinary sphincter (AUS) and adjustable peri-urethral balloons (PUB) ProACT. All options are imperfect at best and persistent SUI is challenging when AUS is not manageable. AIMS: This study analyzed the cumulate experience of our 2 centers with offering PUB implantation for SUI post RP in patients with insufficient improvement from slings. MATERIALS & METHODS: This retrospective study reviewed all patients implanted with second line ProACT. The primary endpoint was continence, defined as 0 pads per day (PPD). The secondary endpoints were 50% decrease in PPD and increases in the Incontinence Quality of Life score (IQOL). Refilling and complications were reported. RESULTS: Between 2007 and 2016, 26 patients were implanted. Five patients have had adjuvant radiotherapy (18%). The mean follow-up was 36 months (±20; min 14-max 128). All patient presented with persistent SUI, using 2.3 PPD (±1; min 1-max 6), and only one sling was removed due to infection. After ProACT with an average 3 mL refilling (±1.2 min 2-max 6), 18 patients (66.7%) were continent. Eight of the remaining patients (29.6%) were improved; their number of PPD decreased from 2.6 to 1. The average IQOL score of those 8 patients increased by 20 points, from 53.4 up to 74.2 (P = .005). Overall 26 patients (96.3%) were improved. The remaining patient was not implanted because of an intraoperative urethral injury and is considered a failed case (3.7%). He had instead an AUS implantation. Three patients (14.8%) needed PUB replacement. CONCLUSION: The limited population of patients from both our centers who presented with persistent SUI after RP, despite sling placement, improved with PUB ProACT implantations without significant complications.

Possibilities of objectivization of pelvic floor muscle exercises in patients with urine leakage after delivery.

BACKGROUND: Examination of pelvic floor muscle function is very important before starting exercises in patients with urine leakage and other pelvic floor dysfunctions. Perineometer and palpation examination is currently being used. A new trend in physiotherapy is the ultrasound examination of pelvic floor muscles. The examination can be performed by abdominal approach or perineal approach. We evaluate 2D and 3/4D images of pelvic floor muscles. METHODS: The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF). OAB-q - overactive bladder questionnaire - short form. The Urinary Incontinence Quality of Life scale (I-QoL) - self-assessment scale for assessing the quality of life of patients with urinary incontinence. Adjusted Oxford scale to assess pelvic floor muscle strength. PERFECT scheme by Laycock and Jerwood. Pelvic floor examination by perineometer (Peritron-Ontario, L4V, Canada). Pelvic floor examination by 2D and 3/4D ultrasound examination (Volunson-i BT 11 Console, VCI volume contrast imaging software, (GE Healthcare Austria GmbH & Co OG, Zipf, Austria, RAB4-8-RS 3D/4D 4-8 MHz probe). High intensity exercise of pelvic floor muscles with stabilization elements. CONCLUSION: The effect of pelvic floor muscle training was objectively proved by the above mentioned objectivization methods with subjective improvement of quality of life. There was also a significant effect of education in USG exercise.

Pelvic floor muscle activation in stress urinary incontinent women: Impact of a distraction task.

AIMS: Our purpose was to explore the involvement of cognition in voluntary and involuntary pelvic floor muscle (PFM) contraction in stress urinary incontinent women. METHODS: PFM contraction monitored by surface electromyography (EMG) was measured without a mental distraction task (DT), and with a DT called "paced auditory serial additional test" (PASAT). Forty stress incontinent women performed voluntary contractions of the external anal sphincter (EAS), and reflex EAS contractions induced by means of coughing were studied using the external intercostal muscle (EIC) EMG pattern. RESULTS: A DT altered PFM pre-activation when coughing: the reaction time between EIC muscle contraction and EAS contraction (called RT3) was respectively -54.94 ms (IQR -87.12; 3.12) without the PASAT and -3.99 ms (IQR: -47.92; 18.69) with a DT (P = 0.02, Wilcoxon's test). Concerning voluntary contraction, women activated their PFM sooner without than with a DT. CONCLUSION: The PASAT altered voluntary and reflex contractions of the PFM in stress urinary incontinent women. Our study suggests that cognition plays a role in urinary pathophysiology. Future studies should investigate rehabilitation programs that consider the role of cognition in stress urinary incontinent women.

Cultural adaptation and validation of the Turkish CONTILIFE: a quality of life questionnaire for urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The objective of the present study was to adapt the CONTILIFE, a quality-of-life questionnaire, into Turkish and to reveal its psychometric properties in women suffering from stress urinary incontinence (SUI). METHODS: Ninety-eight patients with a symptom of SUI participated in the study and filled out the Turkish CONTILIFE. Cronbach's alpha (α) and intraclass correlation coefficients (ICCs) were evaluated for the internal consistency and test-retest reliability, respectively. Exploratory factor analysis was performed to determine the underlying structure. Criterion validity was analyzed using the correlation coefficients between the total and subscale scores of the CONTILIFE and King's Health Questionnaire (KHQ), the Incontinence Impact Questionnaire-7 (IIQ-7), and the Urinary Distress Inventory-6 (UDI-6). RESULTS: Internal consistency was found to be strong to very strong (Cronbach's α: 0.90-0.96). Test-retest reliability was very strong (ICCs = 0.91-0.98, p < 0.001). Exploratory factor analysis revealed five significant factors, explained by 74% of the total variance. Total scores on the CONTILIFE were significantly correlated with the KHQ subscales (r = -0.43 - -0.81), IIQ-7 (r = -0.89), UDI-6 (r = -0.66), and ISI (r = -0.66); (p < 0.01). CONCLUSION: The Turkish CONTILIFE is a valid and reliable tool to determine the influence of SUI on health-related quality of life in Turkish women.

Expectations regarding eHealth among women with stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is a common condition with a major impact on quality of life (QoL). Various factors prevent women from seeking help. However, eHealth (Internet-based therapy) with pelvic floor muscle training (PFMT) is an effective and satisfying intervention for these women. We hypothesize that women with symptoms after regular therapy will profit from eHealth. This study explores the expectations regarding an eHealth intervention among women who still suffer from SUI despite treatment. METHODS: A qualitative study with semistructured interviews was conducted using a grounded theory approach. The study included women with SUI who had ever sought help for their condition. RESULTS: Thirteen women were interviewed, most whom had experience with PFMT and still suffered from moderate-to-severe incontinence. Two themes emerged from data analysis: the need to meet, and eHealth as a tool to bridge obstacles. Women greatly emphasized that a healthcare professional, preferably one they know, should be available with eHealth. Several women indicated that the absence of personal contact caused lack of trust in success. However, several women were willing to use eHealth because its anonymity and flexibility could overcome obstacles in regular care. CONCLUSIONS: eHealth based on PFMT is currently not a preferable treatment modality for women who still suffer from SUI despite treatment. eHealth cannot act as a substitute for their positive experience with personal contact. Some women are willing to use eHealth because of its advantages over regular care. Future experiences with eHealth might enable women with SUI to trust digital care.

Utility of patient decision aids (PDA) in stress urinary incontinence surgery.

INTRODUCTION AND HYPOTHESIS: Patient decision aids (PDAs) facilitate shared decision making allowing patients to make decisions about their healthcare that take into account their personal values and preferences. The aim of this study was to establish whether a PDA used in women requiring stress incontinence surgery is helpful to women when making choices about the treatments they choose by using a Decision Conflict Scale (DCS). METHODS: Forty-five consecutive women were identified as having stress urinary incontinence and had completed all conservative treatments. All patients included in the study had stress urinary incontinence confirmed on urodynamic testing and were given the PDA at the point where they needed to make a decision about surgery. Following completion of the PDA, patients were given a DCS to complete which measures personal perceptions of uncertainty when making a decision about treatment. RESULTS: Forty-three out of 45 (95.5%) patients scored 4/4 for the DCS indicating they were sure of their decision. Two patients (4.5%) scored 3/4 and were therefore unsure of their choice. No patient scored < 3 on the DCS. The choice of procedures varied in all the ages and two women opted to have no treatment. CONCLUSIONS: The use of a PDA in the surgical treatment of stress urinary incontinence reduces decision conflict and ensures patients are sure of their decision, understand the information provided as well as the risk benefit ratio of the various options and feel they have adequate support and advice to make a choice.

Development, validation and initial evaluation of patient-decision aid (SUI-PDA©) for women considering stress urinary incontinence surgery.

INTRODUCTION AND HYPOTHESIS: Following the design, face validation and publication of a novel PDA for women considering SUI surgery, the main objective of the study is to evaluate the usefulness of SUI-PDA© by using a validated tool to obtain patient feedback. METHODS: From July 2018 to March 2019, the PDA, already incorporated into the patient care pathway, was objectively evaluated using the Decisional Conflict Scale (DCS) to determine patients' views. Patients recorded their values and reasons for requests and declines of treatment. The total DCS score, scores from each DCS subgroup and individual patient responses were calculated and analysed. RESULTS: The mean age of the first 20 patients to complete the DCS was 54 years, the mean BMI was 30.1 and the median parity was 3. The average total DCS score was only 9.29 out of 100 (range 0-29.69) suggesting that the PDA was quite useful for patients considering SUI surgery. Overall, the PDA had largely favourable responses across all five DCS subgroups. The 'informed' subgroup had the best score (6.67) while the 'uncertainty' subgroup had the least favourable score (14.58). Despite the procedure pause, the mesh tape option remained on the PDA; however, no patient had chosen this option, with a large proportion citing 'safety' issues as the main reason. Bulking agent injections were the most popular choice (40.0%) and the most commonly performed procedures (50.0%) mainly because of quicker 'recovery'. The second most popular participant choice was colposuspension (35.0%) followed by autologous fascial sling (25.0%), with women citing 'efficacy' as the main reason behind their choice. CONCLUSION: SUI-PDA© was reported by patients and clinicians to be useful with clinical decision-making for SUI surgery. Further validation in a larger patient group is underway.

Vaginal therapy of mild and moderate stress urinary incontinence using Er:YAG laser: a real treatment option.

PURPOSE: To evaluate the effectiveness of vaginal Er:YAG laser as treatment in patients with mild or moderate stress urinary incontinence. METHODS: The study was a prospective, non-randomised, single center study of 33 women treated with two Er:YAG laser applications on an interval of four weeks. Follow-up evaluations were performed 4 and 8 weeks and 6 months after the first vaginal Er:YAG laser application (4 weeks and 5 months after the second vaginal Er:YAG laser application, respectively). The subjective outcomes were assessed using the International Consultation of Incontinence Modular Questionnaire Short Form (ICIQ-SF) and medical history. Patients rated their quality of life on a scale from 0 to 10. RESULTS: The average quality of life (QoL) showed a significant improvement 5 months after both Er:YAG laser applications. The mean QoL score was 6.0 (SD 2.4) and improved to a mean of 7.6 (SD 1.8) (p = 0.004). The mean ICIQ-SF score changed significantly from 12.3 (SD 3.2, median 13, range 8-18) before treatment to 6.8 (SD 4.0, median 7, range 0-15) 6 months after treatment (p <0.001). 24 patients out of 32 (75%) would again choose to have this therapy performed and 25 patients of 32 (78%) would recommend the vaginal Er:YAG laser therapy to a friend. The rate of side effects was low and none of the patients needed a medical treatment. CONCLUSIONS: This study confirms that vaginal Er:YAG therapy can improve clinical and quality of life outcomes in patients with SUI.

Multicenter Analysis of Patient Reported Outcomes Following Artificial Urinary Sphincter Placement for Male Stress Urinary Incontinence.

PURPOSE: Patient centered data are lacking regarding functional and quality of life improvements after artificial urinary sphincter placement. We analyzed the degree of benefit from artificial urinary sphincter placement using ISI (Incontinence Symptom Index), a validated patient reported outcome measure assessing the severity and bother of urinary incontinence, and IIQ-7 (Incontinence Impact Questionnaire-7), a validated patient reported outcome measure assessing the impact and emotional distress of urinary incontinence. MATERIALS AND METHODS: We performed a retrospective review at 4 centers participating in TURNS (Trauma and Urologic Reconstruction Network of Surgeons). Data were available on 51 and 45 patients who underwent artificial urinary sphincter placement, and had preoperative and postoperative ISI and IIQ-7 data, respectively. RESULTS: Mean age was 64.8 years. Median time from surgery to followup questionnaires was 8.5 months. On ISI the median preoperative severity and bother scores were 24 (IQR 20-28.5) and 6 (IQR 4-7), and the median postoperative severity and bother scores were 10 (IQR 4.5-17) and 1 (IQR 0-3), respectively. Improvement on each ISI item was statistically significant. On IIQ-7 the median preoperative impact and distress scores were 9 (IQR 6-13) and 4 (IQR 2-6), and the median postoperative impact and distress scores were 3 (IQR 0-7) and 0 (IQR 0-3), respectively. Improvement on each IIQ-7 item was statistically significant. CONCLUSIONS: Artificial urinary sphincter implantation significantly reduces the severity and bother of stress urinary incontinence symptoms. Longer followup and development are needed of a patient reported outcome measure targeting male stress urinary incontinence.

Mental Health, Sleep and Physical Function in Treatment Seeking Women with Urinary Incontinence.

PURPOSE: We examined how mental health measures, sleep and physical function are associated with the presence and type of urinary incontinence and severity in women seeking treatment for lower urinary tract symptoms. MATERIALS AND METHODS: This baseline cross-sectional analysis was performed in treatment seeking women with lower urinary tract symptoms. All participants completed the LUTS (Lower Urinary Tract Symptoms) Tool (Pfizer, New York, New York), which was used to classify women based on urinary incontinence symptoms and measure severity. The PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire for depression, anxiety, sleep disturbance and physical function, the PSS (Perceived Stress Scale) and the IPAQ-SF (International Physical Activity Questionnaire Short Form) were administered. Multivariable regression modeling was done to assess associations with urinary symptom presence, type and severity. RESULTS: We studied 510 women with a mean ± SD age of 56 ± 14 years. Of the women 82% were Caucasian, 47% were obese and 14% reported diabetes. Urinary incontinence was reported by 420 women (82.4%), including stress urinary incontinence in 70, urgency urinary incontinence in 85, mixed urinary incontinence in 240 and other urinary incontinence in 25. On adjusted analyses there was no difference in any mental health, sleep or physical function measure based on the presence vs the absence of urinary incontinence. Among women with urinary incontinence PROMIS anxiety and sleep disturbance scores were higher in those with mixed urinary incontinence than stress urinary incontinence. Increasing urinary incontinence severity was associated with higher PROMIS depression and anxiety scores, and higher PSS scores. However, higher urinary incontinence severity was not associated with a difference in sleep or physical function. CONCLUSIONS: Among treatment seeking women with lower urinary tract symptoms, increasing urinary incontinence severity rather than the presence or type of urinary incontinence was associated with increased depression, anxiety and stress.

Coital Incontinence in Women With Urinary Incontinence: An International Study.

INTRODUCTION: Coital urinary incontinence (CUI) is not much explored during clinical history, and this could lead to an underestimation of the problem. AIM: To evaluate the prevalence and clinical risk factors of CUI in women with urinary incontinence (UI), and to measure the impact of CUI on women's sexuality and quality of life. METHODS: This was a multicenter international study, conducted in Italy, Greece, the United States, and Egypt. Inclusion criteria were: sexually active women with UI and in a stable relationship for at least 6 months. Exclusion criteria were: age <18 years and unstable relationship. The UI was classified as stress UI (SUI), urgency UI (UUI), and mixed UI (MUI). Women completed a questionnaire on demographics and medical history, in particular on UI and possible CUI and the timing of its occurrence, and the impact of CUI on quality and frequency of their sexual life. MAIN OUTCOME MEASURES: To evaluate the CUI and its impact on sexual life we used the open questions on CUI as well as the International Consultation on Incontinence questionnaire and Patient Perception of Bladder Condition questionnaire. RESULTS: In this study 1,041 women (age 52.4 ± 10.7 years) were included. In all, 53.8% of women had CUI: 8% at penetration, 35% during intercourse, 9% at orgasm, and 48% during a combination of these. Women with CUI at penetration had a higher prevalence of SUI, women with CUI during intercourse had higher prevalence of MUI with predominant SUI, and women with CUI at orgasm had higher prevalence of UUI and MUI with predominant UUI component. Previous hysterectomy was a risk factor for CUI during any phase, while cesarean delivery was a protective factor. Previous failed anti-UI surgery was a risk factor for CUI during penetration and intercourse, and body mass index >25 kg/m2 was a risk factor for CUI at intercourse. According to International Consultation on Incontinence questionnaire scores, increased severity of UI positively correlated with CUI, and had a negative impact on the quality and frequency of sexual activity. CLINICAL IMPLICATIONS: This study should encourage physicians to evaluate the CUI; in fact, it is an underestimated clinical problem, but with a negative impact on quality of life. STRENGTHS & LIMITATIONS: The strength of this study is the large number of women enrolled, while the limitation is its observational design. CONCLUSION: CUI is a symptom that can affect sexual life and should be investigated during counseling in all patients who are referred to urogynecological centers. Illiano E, Mahfouz W, Giannitsas K, et al. Coital Incontinence in Women With Urinary Incontinence: An International Study. J Sex Med 2018;15:1456-1462.

Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon.

AIMS: The SUCCESS trial is a phase III study of the Vesair® balloon in the United States for female stress urinary incontinence (SUI). The purpose of this manuscript is to present the 3 month primary efficacy and tolerability outcome data. METHODS: The SUCCESS trial is a multi-center, prospective, single blind, randomized, sham-controlled study. Subjects were randomized on a 2.33:1 basis to either Vesair balloon placement or placebo. The primary efficacy endpoint was a composite of both a >50% reduction from baseline on 1 h provocative pad weight test and a ≥10-point improvement in symptoms on the Incontinence Quality of Life Survey (I-QOL) questionnaire assessed at the 3 month study visit. RESULTS: A total of 221 subjects were randomized, including 157 treatment arm subjects and 64 controls. The 3 month composite primary efficacy endpoint was achieved in 42.1% of treatment group subjects compared with 28.1% of controls on intention-to-treat analysis (p = 0.046). Treatment arm subjects were significantly more likely to report at least a 50% reduction in incontinence frequency on 7-day voiding diary (55.2% vs 32.3%, P = 0.002, ITT) and more commonly reported their incontinence was improved on Patient Global Impression of Improvement in Incontinence (PGI-I) at 3 months compared with controls (58.0% vs 37.7%, P = 0.007, ITT). No device- or procedure-related serious adverse events nor unanticipated adverse events were reported and no cases of urinary retention were observed. All adverse events fully resolved following balloon removal. CONCLUSIONS: In this phase three trial, the Vesair intravesical balloon achieved 3 month primary and secondary endpoints both objectively and subjectively.

Study design and outcomes measures: The influence of composite endpoints and other design variables on outcomes in a study of a novel device for stress urinary incontinence.

OBJECTIVES: To perform a post hoc analysis of the outcome data from a phase III study of a novel incontinence therapy for female stress incontinence (SUI) and to understand the pitfalls inherent to performing trials in SUI. METHODS: Results of the SUCCESS Trial, a multicenter, prospective, single-blinded, randomized, sham-controlled study were assessed post hoc for parameters and variables consistent with changes in the symptoms or signs of SUI. Subjects were randomized to either the investigative device (Vesair Balloon) placement or placebo. The efficacy endpoint analysis herein evaluated a composite of both a >50% reduction from baseline on 1-hour provocative pad weight test and a ≥10-point improvement in symptoms on the Incontinence Quality of Life (I-QOL) questionnaire assessed at the three-month study visit. Further analysis was performed utilizing more challenging success criteria for each endpoint and a subset of subjects with more severe baseline symptoms. RESULTS: The three-month composite efficacy endpoint was achieved in 42.1% of treatment group subjects compared with 28.1% of control subjects on an intention-to-treat analysis (P = .046). This difference between groups was not evident when analyzing each component of the composite endpoint separately. These endpoints diverged from endpoints involving improvement in PGI-I score and a 50% reduction of incontinence episode frequency as reported by subjects on a diary. CONCLUSIONS: Individual endpoints may not demonstrate a significant treatment effect as standalone SUI measures but may as components of a composite endpoint. Defining patient selection and outcomes assessments is a critical aspect of study design, experimental flaws, and therapeutic accuracy.