A controlled, double-blind, cross-over study of terodiline in motor urge incontinence

In a placebo-controlled, randomized, double-blind, cross-over study, terodiline (50 mg/d) was compared with emepronium (600 mg/d) in 20 patients with motor urge incontinence. Evaluation of clinical efficacy was based on changes in micturition pattern, flow measurements, residual urine, cystometry and patient preferences, and safety on adverse reactions, blood chemistry, urine examinations and ECG. The number of voluntary micturitions decreased from a mean of 21.5 per 48 h on placebo by 1.6 on terodiline and 2.8 on emepronium. Involuntary micturitions decreased from 3.6 per 48 h by 1.3 on both treatments (p less than 0.05). The maximal flow rate decreased from a mean of 24.5 ml/sec to 19.6 ml/sec on emepronium and increased to 25.4 ml/sec on terodiline. Residual urine decreased from a mean of 54 ml to 49 ml on terodiline and increased to 60 ml on emepronium. Volume at first desire to void in the supine position increased on emepronium by 44 ml (p less than 0.05) and on terodiline by 3 ml, on the upright position by 11 ml and 18 ml, respectively. Bladder capacity increased in the supine position on emepronium by 32 ml and decreased on terodiline by 8 ml, in the upright position increased by 9 ml and 5 ml, respectively. The bladder pressure at first desire to void in the supine position increased on emepronium by 2 cmH2O, and decreased on terodiline by 2 cmH2O. The intravesical pressure at strong desire to void decreased on emepronium by 6 cmH2O and on terodiline by 7 cmH2O, in the upright position by 2 cmH2O and 1 cmH2O, respectively. 39% of the patients preferred terodiline, 39% emepronium and 22% placebo.(ABSTRACT TRUNCATED AT 250 WORDS)     

A pilot study of the home application of transcutaneous neuromodulation in children with urgency or urge incontinence.

PURPOSE: We evaluated the efficacy of transcutaneous neuromodulation to treat urinary urgency and urge incontinence in children with nonneurological bladder dysfunction. MATERIALS AND METHODS: Surface neuromodulation was delivered via skin electrodes away from the genital region for a short duration daily on a home treatment basis. Clinical outcome was measured by 3 tools previously tested for reliability including the frequency volume chart, urgency visual analog scale and accident diary ("Dry Pie"). RESULTS: After at least 1 month of application dryness had improved in 73.3% of children, mean urgency score had improved to equate action at urge as being 'easy to hold on' and there was a significant increase in mean voided volume. CONCLUSIONS: Initial evaluation of the home application of surface neuromodulation in children with urgency and/or urge incontinence revealed positive results and warrants a randomized controlled investigation. The finding that children were not completely dry with this treatment in isolation suggests that further study is needed to identify optimal treatment duration and stimulus intensity.     

索利那新治疗尿急及急迫性尿失禁的有效性和安全性分析

和23.04 ml,组间比较差异均无统计学意义(P=0.54,P=0.29).试验组和对照组不良反应总发生率分别为11.7%(14/120)和23.5%(27/115),差异有统计学意义(P<0.05),其中主要不良反应口干发生率分别为5.8%和10.4%(P<0.05). 结论 索利那新治疗尿急和急迫性尿失禁等OAB症状安全有效.     

Depressive symptoms and treatment of women with urgency urinary incontinence

Introduction and hypothesis

Depression is more common in patients with urinary incontinence (UI). Drug or rehabilitation therapy have been shown to be effective in reducing urgency UI (UUI) symptoms, but whether these treatments can ameliorate the negative impact of UUI on the psychological aspects of quality of life is unclear.

Methods

A secondary analysis of an assessor-blinded randomized controlled trial was performed. The number of depressive symptoms was the primary outcome as measured by the Center for Epidemiologic Studies Depression scale (CES-D).

Results

Thirty-six (22 %) subjects had a CES-D score >16 at baseline, the cutoff for having depressive symptoms. A significant association was found between having a CES-D score >16 and lower quality of life related to UI at baseline. The mean CES-D score among those with depressive symptoms at baseline was significantly reduced throughout the study, with a mean of 23.7 at baseline, to 18.3 and 15.2 at the 3-month and 1-year follow-up (p?<?0.001), respectively. The number of participants who had depressive symptoms decreased during the study period only in the physical therapy groups, from 31 at baseline to 28 and 25, at 3 and 12 months, respectively, while there was no such change in the drug group.

Conclusions

Patients with UUI who had depressive symptoms showed significant improvement in their depressive symptoms with treatment over 1 year. This improvement occurred regardless of the type of treatment. This study emphasizes the increasingly recognized problem of undiagnosed depression among middle-aged women with UUI.     

A placebo-controlled, multicentre study comparing the tolerability and efficacy of propiverine and oxybutynin in patients with urgency and urge incontinence.

OBJECTIVE: To assess the tolerability and efficacy of propiverine and oxybutynin in patients with urgency and urge incontinence in a randomized, double-blind placebo-controlled clinical trial. PATIENTS AND METHODS: In all, 366 patients (149 on propiverine, 145 oxybutynin and 72 placebo, ratio 2:2:1) with urgency and urge incontinence were recruited in 32 study centres. Propiverine (group 1, 15 mg three times daily), oxybutynin (group 2, 5 mg twice daily) or placebo (group 3) were administered for 4 weeks, using the double-dummy technique. The dosages were selected specifically to compare the tolerability profile of propiverine with the commonly used therapeutic dosage of oxybutynin. Tolerability was assessed by directly questioning the patients about adverse events at four visits (V-1 before and V0 after a 1-week 'washout' period, V1 after 1 week and V4 after 4 weeks of treatment) during a 5-week surveillance period, and by tolerability ratings of the physicians. Efficacy was assessed using urodynamics at V0 and V4, evaluating the cystometric bladder capacity at maximal and first desire to void, and postvoid residual urine, according to the criteria of the International Continence Society. Additionally, a voiding protocol, overall assessment of clinical symptomatology and efficacy ratings by the physicians were documented. RESULTS: A remarkably high percentage of adverse events was reported in the washout period (VO: 13%, 16% and 18% in groups 1-3, respectively). At V4, the clinically most relevant symptom (dry mouth) occurred in 53% of patients in group 1, in 67% of group 2 and in 28% of group 3. Furthermore, dry mouth was less severe in group 1 than group 2. In contrast to groups 2 and 3, only patients in group 1 showed increasing tolerability during the treatment (from V1 to V4). These tolerability results were further supported by the overall tolerability assessment ('very good' or 'good' tolerability in 67% of group 1, in 59% of group 2 and in 83% of group 3). The urodynamic assessment of efficacy (comparing V0 and V4) showed a statistically significant increase in the mean (sd) maximal cystometric bladder capacity in group 1, being 222 (77) mL at V0 and 311 (125) mL at V4, an increase of 89 (108) mL, and in group 2, at 226 (75) mL and 322 (123) mL, an increase of 96 (106) mL, compared with group 3, at 211 (77) mL and 263 (93) mL, an increase of only 52 (92) mL. The cystometric bladder capacity at first desire to void also increased in group 1 (93 to 160 mL) and group 2 (89 to 160 mL), whereas in group 3 there were only minor changes (93 to 120 mL). Changes in the residual urine volume within and between the treatment groups were minimal and clinically irrelevant. The overall assessment of efficacy showed significant differences between the drugs when compared with placebo. CONCLUSION: Propiverine is a safe and effective drug in the treatment of urgency and urge incontinence; it is as effective as oxybutynin, but the incidence of dry mouth and its severity is less with propiverine than with oxybutynin. The availability of alternative pharmacotherapeutics such as propiverine should reduce the therapeutic failure rate and improves the success rate in the treatment of patients suffering from urgency and urge incontinence.     

Terodiline, emepronium bromide or placebo for treatment of female detrusor overactivity? A randomised, double-blind, cross-over study

In a randomised, double-blind study, 20 women with idiopathic detrusor instability and associated symptoms were treated with terodiline 25 mg bd, placebo, and emepronium bromide 200 mg tds--each drug being given for 3 weeks with placebo as wash-out period before cross-over. The results were evaluated according to drug preference, frequency charts and elimination of detrusor instability on cystometry. Serum levels of both drugs were monitored as control of tablet intake. The preference for terodiline to placebo was statistically significant: 14/3 women (P less than 0.05), and the majority of women (12/4) preferred terodiline to emepronium. Terodiline also gave a small but significant reduction in 24 h micturition frequency and eliminated detrusor instability in almost 50% of the patients (P less than 0.05). Side effects were frequent but mild in all three treatment periods. It was concluded that terodiline offers an alternative in the treatment of female detrusor instability.     

Urodynamics in women with stress and urge incontinence

Subtracted bladder pressure recording is the ideal method to diagnose bladder instability in supine and erect positions. Uroflowmetry demonstrated higher peak flow rates in our stable bladder group. Lateral cystourethrography showed a higher degree of urethral hypermobility in the same group. We believe that cystometry with subtraction is still the cornerstone in the evaluation of these patients. Uroflowmetry and lateral cystography may add some information and deserve further investigation in a large number of patients. Intravesical pressure alone, external urethral sphincter electromyography, and static urethral pressure profilometry were of no value in the evaluation of our patients.     

Conservative therapy of frequency,urgency and urge incontinence: A double-blind clinical trial of flavoxate hydrochloride,exybutinin chloride,emepronium bromide and placebo

Summary Sixty unselected patients from two centers (40+20) with complaints indicating detrusor overactivity or hypersensitivity entered a prospective double-blind cross-over trial to test the efficacy of drug treatment. Two active drugs and a placebo were taken at random during consecutive 3-week periods. The active drugs used were emepronium bromide, which was given to all patients, and flavoxate hydrochloride (given to 30) and oxybutinin chloride (given to the other 30 patients). Anamnestic and cystometric data were recorded after each treatment period and compared with the values on admission. Effect was scored by patient and physician separately. Serious side effects were noted during the administration of emepronium bromide, while flavoxate hydrochloride had even fewer and milder side effects than placebo. Although no objective significant changes could be demonstrated, the total scoring results of oxybutinin chloride were better than that of the three other treatments. The other two active drugs scored no better than placebo.     

Predictors of outcomes in the treatment of urge urinary incontinence in women

Introduction and hypothesis  

Women with urge predominant urinary incontinence received active intervention (drug therapy alone or combined with behavioral therapy) for 10 weeks, then stopped all therapy and were followed for 6 months more. In this planned secondary analysis, we aimed to identify predictors of therapeutic success at 10 weeks (≥70% reduction in incontinence) and of ability to discontinue treatment and sustain improvements 6 months later.     

A novel clinical evaluation of childhood incontinence and urinary urgency.

PURPOSE: There are few clinic based objective tools for the evaluation of urinary urgency and incontinence in children. We report on the known method of frequency volume chart, and describe 2 new tools to determine their effectiveness and reliability. MATERIALS AND METHODS: The mean and standard deviation values for affected children in each age group from 5 to 12 years were calculated from 321 consecutive frequency volume charts. Two new child-based scoring tools quantifying urinary urgency were developed to measure the sensation of urgency and the intensity of response at urge (visual analog score 1 and 2). These tools were tested for reliability. As the quantification of incontinence is problematic in children, a new system of documenting functional severity of leakage per day was designed (Dry Pie) and also tested for reliability. RESULTS: Age related mean bladder storage volumes and standard deviations were established for children with incontinence. The novel urgency visual analog measure proved reliable, although only scale 2 would be useful in clinical practice. The incontinence Dry Pie diary was also shown to be reliable for 2 weeks and easily completed at home by the children. CONCLUSIONS: As a result of this study clinic based intervention can include reliable quantification of urinary urgency (visual analog scale 2) and a functional measure of the severity of incontinence (Dry Pie).     

Voiding cystourethrography findings in elderly women with urge incontinence

PURPOSE: We report voiding cystourethrography findings associated with urge incontinence in elderly women. MATERIALS AND METHODS: Two observers jointly reviewed voiding cystourethrograms of 50 cognitively intact and mobile elderly female participants in a drug trial for urge incontinence and 19 continent volunteers. Multichannel urodynamic testing was performed in all subjects. Bladder wall trabeculation and diverticula, cystocele and vesicoureteral reflux were noted. Maximal bladder capacity, post-void residual, and history of bladder suspension and hysterectomy were obtained from clinical records. RESULTS: Of the incontinent women 35 (70%) had trabeculation, which was mild in 30 (60%) and moderate in 5 (10%), and 41 (82%) had cystocele, which was mild in 23 (46%), moderate in 15 (30%) and severe in 3 (6%). Maximal bladder capacity ranged from less than 100 to more than 900 cc, and was greater than 500 in 37 incontinent women (74%). Of the continent women 16 (84%) had smooth bladders, 2 had mild (11%) and 1 had moderate (5%) trabeculation, and 11 (58%) had cystocele, which was mild in 8 (42%) and moderate in 3 (16%). In 7 continent women maximal bladder capacity was greater than 500 cc (37%). Differences between the 2 groups in regard to bladder wall trabeculation, maximal bladder capacity and presence of cystocele were significant at p<0.05. CONCLUSIONS: Large bladder capacity, bladder wall trabeculation and small to moderate cystocele on voiding cystourethrography are associated with urge incontinence in the elderly female population.     

Maximal external electrical stimulation for treatment of neurogenic or non-neurogenic urgency and/or urge incontinence

Maximal electrical stimulation by intravaginal or intra-anal electrodes was used for treatment of 75 patients with complaints of urgency and/or urge incontinence. The patient group consisted of 51 women and 24 men. A neurogenic background was present in 30 of the women who had a diagnosis of multiple sclerosis, in the other 45 patients the pathology was idiopathic in nature. After 3 weeks of maximal electrical stimulation treatment, composed of 15 sessions of 20 minutes duration, 59% of the patients had urodynamic and subjective improvement and an additional 40% only subjective improvement. One patient found no benefit after this treatment. The effect lasted for at least 2 years in 64% of the idiopathic group. In the multiple sclerosis group relapse occurred within about 2 months. Re-treatment of the failures was successful again immediately; the multiple sclerosis patients do need daily home stimulation treatments. © 1996 Wiley-Liss, Inc.     

Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials

OBJECTIVE: To assess the efficacy of physical therapies for first-line use in the treatment of urge urinary incontinence (UUI) in women, using a systematic review of randomized clinical trials (RCTs). MATERIALS AND METHODS: A computer-aided and manual search was carried out for RCTs published between 1980 and 1999 investigating the treatment of UUI defined by the keywords 'physical therapies', e.g. bladder (re)training (including 'behavioural' treatment), pelvic floor muscle (PFM) exercises, with or without biofeedback and/or electrical stimulation. The methodological quality of the included trials was assessed using methodological criteria, based on generally accepted principles of interventional research. RESULTS: Fifteen RCTs were identified; the methodological quality of the studies was moderate, with a median (range) score of 6 (3-8.5) (maximum possible 10). Eight RCTs were considered of sufficient quality, i.e. an internal validity score of >/= 5.5 points on a scale of 0-10, and were included in a further analysis. Based on levels-of-evidence criteria, there is weak evidence to suggest that bladder (re)training is more effective than no treatment (controls), and that bladder (re)training is better than drug therapy. Stimulation types and parameters in the studies of electrical stimulation were heterogeneous. There is insufficient evidence that electrical stimulation is more effective than sham electrical simulation. To date there are too few studies to evaluate effects of PFM exercise with or without biofeedback, and of toilet training for women with UUI. CONCLUSION: Although almost all studies included reported positive results in favour of physical therapies for the treatment of UUI, more research of high methodological quality is required to evaluate the effects of each method in the range of physical therapies.     

Urinary bacteria in adult women with urgency urinary incontinence

Introduction and hypothesis

This study’s aims were to detect and quantify bacterial DNA in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence (UUI) without clinical evidence of urinary tract infection (UTI) and to determine if the presence of bacterial DNA in baseline urine relates to either baseline urinary symptoms or UTI risk after urinary tract instrumentation.

Methods

Women without clinical evidence of baseline UTI were randomized to cystoscopic onabotulinum toxin A injection and oral placebo medication versus cystoscopic placebo injection and active oral medication. Bacterial DNA in participants’ catheterized urine was measured by quantitative polymerase chain reaction (qPCR).

Results

Bacterial DNA was detected in the urine of 38.7 % of participants (60 out of 155). In these 60 qPCR-positive participants, baseline daily UUI episodes were greater than in the 95 qPCR-negative participants (5.71 [±2.60] vs 4.72 [±2.86], p?=?0.004). Neither symptom severity by questionnaire nor treatment outcome was associated with qPCR status or with qPCR level in qPCR-positive subjects. In contrast, the presence of urinary bacterial DNA was associated with UTI risk: only 10 % of the qPCR-positive women developed a UTI post-treatment, while 24 % of the qPCR-negative women did so. The median qPCR level for qPCR-positive samples did not differ significantly by UTI status (UTI 2.58?×?10⁵ vs no UTI 1.35?×?10⁵ copies/mL, p?=?0.6).

Conclusions

These results may indicate a urinary bacterial contribution to both baseline UUI and the risk of post-treatment UTI.     

Significance of the urodynamic study in the diagnosis of urinary incontinence in women

Comparing the results of clinical evaluations and urodynamic studies in 175 consecutive incontinent females, we came to different diagnoses in 12.6%. If we rely only on the clinical diagnosis, this means that at least 1 out of 10 incontinent females with no urodynamic work-up will have a wrong or incomplete therapy. In respect to the exact indication, especially for operative therapy, urodynamic work-up seems therefore necessary in different forms of female urinary incontinence.     

Difference in quality of life in women with urge urinary incontinence compared to women with stress urinary incontinence

Introduction  We evaluated whether women with urge urinary incontinence (UUI) have lower quality of life (QOL) than women with other forms of urinary incontinence. Methods  Patients completed three validated questionnaires when presenting for evaluation at a urogynecology practice and were divided into four groups based on their responses: those with symptoms of stress urinary incontinence (SUI), UUI, both SUI and UUI (mixed UI), and neither SUI nor UUI (controls). Results  A total of 465 women were included: 53 women with UUI (11.4%), 101 with SUI (21.7%), 200 with mixed UI (43%), and 111 controls (23.9%). Overall, there was a significant difference (p < 0.001) in PFIQ bladder scale scores as a function of UI group, with individual mean PFIQ scores of 17.1 for controls, 22.3 for SUI, 32.7 for UUI, and 36.8 for mixed UI. Individually, all seven questions in the PFIQ bladder domain were significantly different by group (p ≤ 0.001). Conclusions  Women with UUI and mixed UI have lower QOL scores than women without incontinence or with only SUI. The project was approved by the IRB at Hartford Hospital.     

Placebo responses in the treatment of urge incontinence

The treatment options of patients with urge incontinence are behavioral therapy, drug therapy and surgery. The evaluation and reported efficacy of these treatments, with particular reference to the potential placebo response in treatment is discussed.     

Efficacy and safety of two doses of tolterodine versus placebo in patients with detrusor overactivity and symptoms of frequency, urge incontinence, and urgency: urodynamic evaluation

Summary Tolterodine is a new competitive muscarinic receptor antagonist developed for the treatment of the unstable bladder. A total of 242 patients were enrolled in a multicenter, multinational, randomized, double-blind, placebo-controlled study conducted over a period of 4 weeks in patients with detrusor overactivity and symptoms of frequency, urgency, and urge incontinence. The objective of the study was to compare the efficacy and safety of tolterodine given at 1 or 2 mg b.i.d. versus placebo. At week 4 a statistically significant increase in the volume at first contraction (p = 0.030) and maximal cystometric capacity (p = 0.034) was only in the tolterodine 2 mg b.i.d. group. Tolterodine was safe and generally well tolerated. The incidence of dry mouth, as the most commonly reported adverse event, was only 9% and of mild to moderate intensity.