Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder.

PURPOSE: The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). METHODS: This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3 months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12 months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. RESULTS: The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12 months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). CONCLUSION: The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12 months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.

Effect of severity of urinary incontinence on quality of life in women.

AIMS: While the effect of different types of incontinence on the quality of life (QoL) has been clearly documented, the information about the impact of incontinence severity on QoL in women is lacking. Therefore, we investigated whether increasingly severe degrees of incontinence were linearly correlated with poorer QoL. METHODS: We included 391 incontinent women and 81 continent volunteers in the study and assessed them in accordance with routine clinical practice. A 24 h pad-weight test was used to objectively quantify the incontinence severity. We then stratified participants according to incontinence type and severity and assessed correlations between incontinence severity and Patient Perception of Bladder Condition (PPBC), International Consultation on Incontinence short-form questionnaire (ICIQ-SF), and King's Health Questionnaire (KHQ) quality of life scores in the entire study population and in individual groups according to incontinence type. RESULTS: Minimal incontinence was associated with significant negative impact on QoL, as measured by all quality of life assement tools. There were nonlinear correlations between scores on individual questionnaires and daily leakage volumes. Stress urinary incontinence had a weaker impact on quality of life than urge or mixed incontinence, as measured by PPBC (P < 0.0001), KHQ part 1 (P < 0.0001), and KHQ part 2 (P < 0.001). Stress urinary incontinence also had a weaker impact on QoL than mixed incontinence as measured by ICI-Q (P = 0.007). CONCLUSIONS: This study demonstrated that even mild urinary leakage significantly reduces the QoL, while subsequent increase in the degree of incontinence has only minimal additional effect. There was no linear correlation between incontinence severity and QoL.

Evaluation of intra-individual test-re-test variability of uroflowmetry in healthy women and women suffering from stress, urge, and mixed urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the intra-individual variability of uroflowmetry (UFM) in healthy control subjects and women suffering from stress, urge, and mixed urinary incontinence. METHODS: A total of 35 healthy controls (group A) and 105 women suffering from urinary incontinence were enrolled in the study. Thirty-five women suffered from stress urinary incontinence (group B), 35 women suffered from mixed urinary incontinence (group C), and 35 women with overactive bladder both dry and wet (group D). All participants were asked to perform UFM measurement three times. The following parameters were analyzed: voided volume (VV), peak flow (Qmax), average flow (Qave), volume-corrected peak flow cQmax (cQmax = Qmax/2√ VV), volume-corrected average flow (cQave = Qave/2√ VV), and postvoid residual volume (PVR). Statistical analysis was performed using the analysis of variance on repeated measurements. Relative error was calculated using variation coefficients reported as a percentage of the average. All descriptive characteristics were reported as means ± standard deviation (SD). p values ≤0.05 were considered statistically significant. RESULTS: No statistically significant intra-individual difference in any of the recorded parameters was identified among the three UFM recordings in groups A, C, and D. The intra-individual variability of the following parameters reached statistical significance in patients suffering from stress urinary incontinence (group B): Qmax (p = 0.0016), Qave (p = 0.0005), and cQave (p = 0.0389). A significant difference was only observed in comparison between the first and second consecutive recordings. CONCLUSIONS: This study provides evidence supporting the high yield and good intra-individual reproducibility of UFM.

Evaluation of Voiding Parameters in Healthy Women Using Sound Analysis.

OBJECTIVES: Sonouroflowmetry represents a novel method for estimating urinary flow parameters. The aim of this study was to compare the urinary flow parameters acquired using sonouroflowmetry with those of standard uroflowmetry in healthy female volunteers. METHODS: Thirty-six healthy female volunteers (aged 25-54 years) were subjected to standard uroflowmetry. Simultaneously, subjects dialed a dedicated number on a mobile phone and kept recording until urination was finished. Sound data were analyzed and compared to the uroflowmetry data. Of 218 recordings, 183 were included in the final analysis. Thirty-four measurements were excluded for voided volume <150 mL or technical problems during the recording. A linear model was fitted to calculate the urinary flow parameters and the voided volume from data obtained by sonouroflowmetry. Subsequently the matching datasets of UF and SUF were compared with respect to flow time, voided volume, maximum (Qmax ) and average (Qave ) flow rate. Pearson's correlation coefficient (PCC) was used to compare parameters recorded by uroflowmetry with those calculated based on sonouroflowmetry recordings. RESULTS: A strong correlation (PCC = 0.95) was noted between uroflowmetry recorded flow time and duration of the sonouroflowmetry sound signal. The voided volume measured by uroflowmetry showed a moderate correlation (PCC = 0.68) with the calculated area under the sonouroflowmetry curve. Qmax recorded using uroflowmetry and sonouroflowmetry recorded peak sound intensity showed a weak correlation (PCC = 0.38). CONCLUSIONS: This study validates the basic concept of using sound analysis to estimate urinary flow parameters and voided volume.

Validating of a Novel Method for Electronically Recording Overactive Bladder Symptoms in Men.

OBJECTIVE: The goal of this study was to compare a novel wireless phone and web based technology to record and store overactive bladder symptoms (OAB-S) to a traditional pen and paper micturition chart. METHODS: Overactive bladder symptoms were recorded over a period of 3 days using both an electronic micturition chart (EMC) and the standard pen and paper micturition chart (MC). Twenty-nine men, with lower urinary tract symptoms (LUTS), were included in the study. Dropout rate, patient's preference, and correlation between the quality of life measures (QoL) and symptoms recorded with EMC versus MC, were assessed and compared. RESULTS: Of the total number of 29 patients enrolled into the study, 24 completed the full 3-day trial using MC and 27 using EMC. MC was preferred by 50%, while EMC was preferred by 50% of participants. Using MC, 21% of patients forgot to record at least one episode of urgency, versus 17% using EMC, 17% forgot to record at least one micturition using MC versus 8% using EMC. A statistically significant correlation was found between lower severity of OAB-S and higher QoL, using both recording methods. CONCLUSIONS: In this study population, recording symptoms with EMC did not prove to be preferable compared to MC; however, EMC provided the same level of accuracy with the same or better adherence to the study protocol.

Intravesical instillation of onabotulinum toxin A embedded in inert hydrogel in the treatment of idiopathic overactive bladder: A double-blind randomized pilot study.

OBJECTIVE: It was hypothesized that increasing the time for which onabotulinum toxin A (OnabotA) is exposed to the urothelium following intravesical instillation will augment its effect. TC-3 is an inert heat-sensitive hydrogel, which creates an intravesical bulk providing a slow release of the embedded drug after instillation. The aim of this study was to evaluate the effect of OnabotA, embedded in inert TC-3 hydrogel, in patients with idiopathic overactive bladder (OAB). METHODS: In total, 39 female patients (age 30-65, average 53.8 years) with OAB symptoms were randomized for the study into four groups, each receiving 50 ml of the following intravesical instillations: Group A, 0.9% NaCl (placebo, n = 11); Group B, TC-3 gel + 200 U OnabotA (n = 9); Group C, TC-3 gel + 200 U OnabotA + dimethyl sulfoxide (DMSO) (n = 10); and Group D, DMSO (n = 9). The parameters were compared before and 1 month after treatment. RESULTS: When comparing parameters using conventional statistical methods (Kruskal-Wallis test), no statistically significant changes were observed within the groups. Comparison of the medians using an analysis based on the mathematical gnostics showed the superiority of the method used in Group B over the other groups in the following parameters: number of urgency grade 3 + 4 episodes/72 h, number of leakage episodes/72 h, Overactive Bladder Questionnaire total score and Patient Perception of Bladder Condition total score. Group D showed its superiority over the other groups in respect to the number of nocturia episodes/72 h. CONCLUSIONS: The results indicate that intravesical instillation of OnabotA, embedded in TC-3 gel, could become an alternative to intramural injection for a well-selected subgroup of patients.

Vacuum-assisted vaginal delivery and levator ani avulsion in primiparous women.

OBJECTIVE: We compared the incidence and type of levator ani avulsion diagnosed by translabial ultrasound evaluation in primiparous women six months after vacuum-assisted or spontaneous vaginal delivery. MATERIAL AND METHODS: This retrospective observational study was performed between January 2011 and December 2013. Primiparous women six months after vacuum-assisted vaginal delivery and after spontaneous vaginal delivery underwent translabial ultrasound evaluation. The distance between the urethra and fibers of the musculus levator ani puborectalis (levator-urethra gap) was measured. A levator-urethra gap >25 mm was considered a musculus levator ani avulsion. RESULTS: In total, 184 women participated in the study. Among them, 92 had vacuum extraction and 92 had uncomplicated spontaneous delivery. A longer levator-urethra gap on both sides of the pubic bone was found in women after vacuum-assisted vaginal delivery (p < 0.0001 for both sides). Musculus levator ani avulsion was identified in 20 women (unilateral in 16 cases and bilateral in four cases). No difference in an incidence of musculus levator ani avulsion was identified in women after vacuum-assisted vaginal delivery [11/92 (12%)] compared to spontaneous delivery [9/92 (10%); p = 0.81]. CONCLUSION: Vacuum-assisted vaginal delivery in primiparous women is associated with a longer levator-urethra gap but not with a higher frequency of avulsion of the musculus levator ani.

Comparison between uroflowmetry and sonouroflowmetry in recording of urinary flow in healthy men.

OBJECTIVES: To evaluate the accuracy of sonouroflowmetry in recording urinary flow parameters and voided volume. METHODS: A total of 25 healthy male volunteers (age 18-63 years) were included in the study. All participants were asked to carry out uroflowmetry synchronous with recording of the sound generated by the urine stream hitting the water level in the urine collection receptacle, using a dedicated cell phone. From 188 recordings, 34 were excluded, because of voided volume <150 mL or technical problems during recording. Sonouroflowmetry recording was visualized in a form of a trace, representing sound intensity over time. Subsequently, the matching datasets of uroflowmetry and sonouroflowmetry were compared with respect to flow time, voided volume, maximum flow rate and average flow rate. Pearson's correlation coefficient was used to compare parameters recorded by uroflowmetry with those calculated based on sonouroflowmetry recordings. RESULTS: The flow pattern recorded by sonouroflowmetry showed a good correlation with the uroflowmetry trace. A strong correlation (Pearson's correlation coefficient 0.87) was documented between uroflowmetry-recorded flow time and duration of the sound signal recorded with sonouroflowmetry. A moderate correlation was observed in voided volume (Pearson's correlation coefficient 0.68) and average flow rate (Pearson's correlation coefficient 0.57). A weak correlation (Pearson's correlation coefficient 0.38) between maximum flow rate recorded using uroflowmetry and sonouroflowmetry-recorded peak sound intensity was documented. CONCLUSIONS: The present study shows that the basic concept utilizing sound analysis for estimation of urinary flow parameters and voided volume is valid. However, further development of this technology and standardization of recording algorithm are required.

Systemic effects of intratympanic dexamethasone therapy.

OBJECTIVE: The study aimed to assess the possible systemic effects of intratympanic dexamethasone (IT-Dex) on the hypothalamic-pituitary-adrenal (HPA) axis, inflammation, and bone metabolism. DESIGN: A prospective cohort study including 30 adult patients of a tertiary referral ENT clinic treated with 9.6 mg IT-Dex over a period of 10 days was carried out. METHODS: Effects on plasma and salivary cortisol concentrations (basal and after low-dose (1 µg) ACTH stimulation), peripheral white blood cell count, and biomarkers for bone turnover were measured before (day 0) and after IT-Dex (day 16). Additional measurements for bone turnover were performed 5 months after therapy. Clinical information and medication with possible dexamethasone interaction were recorded. RESULTS: IT-Dex was well tolerated, and no effect was detected on the HPA axis (stimulated plasma and salivary cortisol concentration on day 0: 758±184 and 44.5±22.0 nmol/l; day 16: 718±154 and 39.8±12.4 nmol/l; P=0.58 and 0.24 respectively). Concentrations of osteocalcin (OC) and bone-specific alkaline phosphatase (BSAP) did not differ after dexamethasone (OC on days 0 and 16 respectively: 24.1±10.5 and 23.6±8.8 µg/l; BSAP on day 0, 16, and after 5 months respectively: 11.5±4.2, 10.3±3.4, and 12.6±5.06 µg/l); similarly, there was no difference in the peripheral white blood cell count (5.7×10(12)/l and 6.1×10(12)/l on days 0 and 16 respectively). CONCLUSIONS: IT-Dex therapy did not interfere with endogenous cortisol secretion or bone metabolism.

Persistence with first line anticholinergic medication in treatment-naïve overactive bladder patients.

OBJECTIVE: The aim of this study was to evaluate the persistence of first line anticholinergic medication use by patients with overactive bladder (OAB). Data from a hospital outpatient database were matched with information obtained by a telephone survey of patients to determine which patients discontinued use of anticholinergic medication and to identify the reasons underlying discontinuation. MATERIAL AND METHODS: The study group included 377 OAB patients (52 men, 325 women) with a mean age of 60.29 ± 13.84 years. In total, 189 patients (50.1%) were treated with trospium (median dose 27.86 ± 12.73 mg), 41 patients (10.9%) with propiverine (28.17 ± 4.97 mg), nine patients (2.4%) with extended-release tolterodine (4.0 ± 0 mg), 48 patients (12.7%) with solifenacin (5.94 ± 1.97 mg) and 90 patients (23.9%) with fesoterodine (6.09 ± 2.01 mg). RESULTS: The median time for persistence with the first line anticholinergic treatment was 6.53 ± 3.84 months. Persistence was significantly higher in patients treated with anticholinergic medication with an extended-release formulation than in patients treated with immediate-release anticholinergics. The most common reasons for termination of treatment were healing/resolution of symptoms (35.9%), low effectiveness (30.9%) and side-effects (23.7%). CONCLUSIONS: More than half of the OAB patients were not satisfied with their first line treatment. Other treatment options should be sought, such as changing the medication or dosage, or possibly combining treatments.

A superior semicircular canal dehiscence syndrome multicenter study: is there an association between size and symptoms?

OBJECTIVE: The aim of this investigation was to determine if there is any association between the size of the canal dehiscences and the symptoms and signs of patients presenting with the superior semicircular canal dehiscence syndrome. STUDY DESIGN: Prospective multicenter study. SETTING: Tertiary referral center. PATIENTS: Twenty-seven patients, 14 females and 13 males, aged 25 to 83 years, coming from Switzerland, France, Belgium, or Italy, with dehiscence of the superior semicircular canal diagnosed by high-resolution computed tomographic scans of the temporal bone. INTERVENTIONS: Audiologic tests, a battery of vestibular tests (Tullio phenomenon, Hennebert sign, Valsalva maneuver), vestibular evoked myogenic potentials (VEMPs), and high-resolution computed tomographic scans of the temporal bone. MAIN OUTCOME MEASURES: Association between the symptoms/signs and the size of the superior canal dehiscence. RESULTS: Clinically patients could be divided into three different groups: Superior canal dehiscences (> or =2.5 mm) presented predominantly with cochleovestibular symptoms and/or signs (sensitivity, 91.7%; specificity, 70%), whereas smaller one's showed either cochlear or vestibular dysfunction. Patients with larger dehiscences were significantly more associated with vestibulocochlear symptoms/signs, lower VEMP thresholds, and objective vestibular findings (e.g., Tullio phenomenon) than subjects with smaller bony defects. No significant association between the size of the dehiscence and the audiogram pattern or individual findings could be found. The location of the dehiscence seemed to have no influence on the clinical manifestation and findings. CONCLUSION: Patients with larger superior canal dehiscences show significantly more vestibulocochlear symptoms/signs, lower VEMP thresholds, and objective vestibular findings compared with smaller ones. Smaller dehiscences mainly present with either cochlear or vestibular dysfunction.