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PubMed2005

Botulinum-A toxin detrusor and sphincter injection in treatment of overactive bladder syndrome: objective outcome and patient satisfaction.

OBJECTIVE: We investigated the effect of botulinum-a toxin injections into the detrusor and external sphincter muscle in patients with overactive bladder (OAB) symptoms. METHODS: We included 44 patients - 41 women and three men with a mean age of 66.1 years - who were suffering from OAB symptoms that were refractory to anticholinergic treatment. We injected 200-300 U of BTX-A (Botox) into the detrusor muscle; 22 patients also received external sphincter injections. For outcome analysis, we used a bladder diary, a urodynamic examination, and a questionnaire that consisted of 27 validated questions. RESULTS: Changes in the bladder diary 4 weeks and 3, 6, and 9 months after BTX-A injection were as follows: Micturition frequency was reduced by 12%, 16%, 13% and 9%, respectively. Average pad use decreased from 4.2 pads per day to at most 2.4 pads per day after 6 months. Urodynamic changes were most distinct after 4 weeks: the volume when the first uninhibited detrusor contraction occurred increased from 149+/-18.2 mL to 263 +/- 24.2 mL, and maximum cystometric bladder capacity increased from 228 +/- 19.2 mL to 305 +/- 19.0 mL. Subjectively, 86% of the patients would choose this procedure for their bladder condition again. Residua 4 weeks after additional injection into the sphincter muscle were distinctly smaller than in the "only detrusor" group. CONCLUSIONS: BTX-A detrusor and sphincter injection is very effective in treating OAB symptoms. For patients who might be expected to have residual urine after injection only into the detrusor, additional injection of low doses of BTX-A into the external sphincter muscle could be one option to reduce that risk.

Adult↗

PubMed1997

Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis.

OBJECTIVES: To examine the safety, efficacy, and tolerability of tolterodine in four randomized, double-blind, parallel, multicenter, 12-week studies of patients with overactive bladder. METHODS: Two of the four studies compared tolterodine (2 mg twice daily) to oxybutynin (5 mg three times daily) and placebo, one study compared tolterodine (2 mg twice daily) to oxybutynin (5 mg three times daily), and one study compared two dosages of tolterodine (1 and 2 mg twice daily) to placebo. Efficacy was determined from micturition diaries and patient perception of their bladder condition. Safety and tolerability were assessed from adverse events and laboratory measures. RESULTS: A total of 1,120 patients were randomized and treated at 134 centers. For the primary efficacy variable, the number of micturitions/24 hours, pooled results showed a significant decrease from baseline for the 1 mg tolterodine (P < 0.001), 2 mg tolterodine (P < 0.001), and 5 mg oxybutynin (P < 0.01) groups, compared to placebo. Both tolterodine doses and oxybutynin significantly decreased incontinence episodes/24 hours and significantly increased volume voided/micturition, compared to placebo. Tolterodine at a dose of 2 mg twice daily and 5 mg oxybutynin twice daily were significantly more effective in improving patient perception of bladder condition than placebo. Tolterodine at a dose of 2 mg and 5 mg oxybutynin were equivalent in their effectiveness. Tolterodine at doses of 1 mg and 2 mg were tolerated significantly better than oxybutynin when adverse events, dry mouth (both frequency and intensity), dose reductions, and patient withdrawals were considered. CONCLUSIONS: Although oxybutynin is highly effective, its clinical utility is limited by systemic side effects that lead to frequent discontinuation of treatment or dose reductions. Patients receiving tolterodine should not experience these limitations and instead will get safe and long-term effective treatment for their condition.

Adult↗

PubMed2001

Efficacy, tolerability and safety profile of propiverine in the treatment of the overactive bladder (non-neurogenic and neurogenic).

Propiverine hydrochloride (propiverine) is a compound that has neurotropic and musculotropic effects on the urinary bladder smooth muscle. Controlled clinical trials have shown its effectiveness in treating detrusor hyperreflexia and in treating patients with symptoms of an overactive bladder: this is true not only for adults but in children and the elderly as well. European and Japanese studies have also documented that propiverine is well tolerated. It is better tolerated than oxybutynin (particularly in regard to frequency and severity of dryness of the mouth). In several Japanese studies authors demonstrated that propiverine is well tolerated on a long-term basis. Voigt reported an adverse event incidence rate of 13% in a follow-up investigation during 10 years of treatment. A post-marketing drug surveillance consisting of 4390 patients provided additional data concerning efficacy and safety of propiverine. It is one of the few drugs recommended for the treatment of detrusor overactivity by the Committee on Pharmacological Treatment during the First International Consultation on Incontinence.

Adult↗

PubMed2004

Passive transfer of Sjogren's syndrome IgG produces the pathophysiology of overactive bladder.

OBJECTIVE: The presence, in patients with primary and secondary Sjogren's syndrome (SS), of autoantibodies that acutely inhibit M(3) muscarinic receptor (M3R)-mediated bladder contractions is difficult to reconcile with the fact that symptoms of detrusor overactivity and other features of cholinergic hyperresponsiveness occur in this disease. This study was undertaken to examine the in vivo effects of these autoantibodies on bladder function by examining bladder responsiveness and compliance following passive transfer of patient IgG to mice. METHODS: Contractile responses of isolated bladder strips both to the muscarinic agonist carbachol and to electrically evoked acetylcholine release were measured 48 hours after injection of mice with patient or control IgG. A whole bladder assay with intact neuronal pathways was developed to assess bladder wall compliance on filling cystometry. Expression of M3R in bladders from IgG-injected mice was assessed by immunohistochemistry. RESULTS: Passive transfer of SS IgG with inhibitory anti-M3R activity produced a paradoxical increase in contractile responses of detrusor strips to cholinergic stimulation. Cystometry of whole bladders revealed a corresponding decrease in bladder wall compliance and phasic detrusor contractions upon filling, replicating the urodynamic features of an overactive bladder. The features of cholinergic hyperresponsiveness were associated with increased postsynaptic M3R expression and were reproduced by injecting mice with a rabbit antibody against the second extracellular loop of M3R. CONCLUSION: These findings are consistent with the notion that there is initial inhibition of parasympathetic neurotransmission by antagonistic autoantibodies to M3R, which produces a compensatory increase in M3R expression in vivo. The enhanced cholinergic responses during bladder distention result in detrusor overactivity. We conclude that the overactive bladder associated with SS is an autoantibody-mediated disorder of the autonomic nervous system, which may be part of a wider spectrum of cholinergic hyperresponsiveness.

Animals↗

PubMed2006

Minimal clinically important change in urinary incontinence detected by a quality of life assessment tool in overactive bladder syndrome with urge incontinence.

AIMS: The objective of this research was to detect a minimal clinically important change (MCIC) in frequency of incontinence episodes in Japanese patients with overactive bladder syndrome (OAB) based on the change in domain scores of health-related quality of life (HRQoL). METHODS: The patients (n = 659) enrolled for the 8 weeks, randomized, double-blind, placebo-controlled study of an oxybutynin transdermal patch were used for the analysis. The endpoints of the study were the change in frequency of incontinence episodes and the domain scores of King's health questionnaire (KHQ) from baseline to the end of treatment. To search a threshold of the change of incontinence frequency that apparently improves patient's quality of life (QOL), we calculated mean changes of selected five KHQ domain scores for nine patient groups divided by the amount of change of incontinence frequency. A minimum value of the change of incontinence frequency in the groups with apparent improvement in the QOL scores was defined as an MCIC of incontinence frequency. RESULTS: The apparent improvement of KHQ domain scores was seen in the patient groups whose incontinence episodes decreased more than three times per week (/w) after treatment. This result was common in almost all domain scores, but more relevant for the domains related to patients' life limitations. CONCLUSION: Japanese OAB patients can feel their QOL improved if their incontinence episodes decrease more than 3 times/w. This suggests that the reduction of '3 times /w' is an MCIC of incontinence frequency for Japanese OAB patients.

Administration, Cutaneous↗

PubMed2005

Treatment of overactive bladder: a model comparing extended-release formulations of tolterodine and oxybutynin.

OBJECTIVE: The objective of this study was to compare 1-year total healthcare costs for patients with overactive bladder (OAB) initiating treatment with extended-release formulations of tolterodine and oxybutynin: tolterodine tartrate extended-release capsules (tolterodine ER) versus extended-release oxybutynin chloride (oxybutynin ER). METHODS: A model was developed from the payer perspective using data from the PharMetrics Patient-Centric database. Monthly discontinuation rates were derived from a cohort of newly treated patients with OAB (tolterodine ER, n = 15 394 or oxybutynin ER, n = 7934). All were assumed to be receiving therapy for at least 1 month. Medical management costs were based on reimbursement for all services for a matched cohort of patients taking tolterodine ER and oxybutynin ER. Medical management costs for those discontinuing therapy were based on patients receiving OAB care without pharmacotherapy (n = 29 992). Drug costs were from AnalySource (December 2004). RESULTS: After the 11-month follow-up period, 21% of patients taking tolterodine ER and 15% of patients taking oxybutynin ER remained on original therapy. One-year average total costs per patient for those started on tolterodine ER were dollar 8876 and dollar 9080 for oxybutynin ER, a difference of dollar 204 per year. Sensitivity analyses indicated results were robust to changes in drug cost and probability of discontinuation. When discontinuation rates were held equal, cost differences continued to favor tolterodine ER (21%, dollar 272/yr; 15%, dollar 233/yr). CONCLUSION: Those taking tolterodine ER had lower monthly drug and medical management costs. This resulted in a total average annual cost savings of dollar 204 per patient for those started on tolterodine ER. At the end of 1 year, patients with OAB were more likely to remain on original drug treatment taking tolterodine ER versus oxybutynin ER.

Aged↗

PubMed2003

Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial.

OBJECTIVE: To compare extended-release (ER) tolterodine and immediate-release (IR) oxybutynin with placebo in Japanese and Korean patients with an overactive bladder (OAB). PATIENTS AND METHODS: Men and women aged >or= 20 years with symptoms of urinary urgency, urinary frequency (>or= 8 micturitions/24 h), urge incontinence (>or= 5 episodes/week) and symptoms of OAB for >or= 6 months were randomized to double-blind treatment with tolterodine ER 4 mg once daily, oxybutynin IR 3 mg three times daily or placebo for 12 weeks. Efficacy assessments included changes from baseline in numbers of incontinence episodes per week, voids/24 h and mean volume voided/void. Patient perceptions of bladder condition, urgency and treatment benefit were also assessed. RESULTS: In all, 608 patients were randomized to treatment with tolterodine (240), oxybutynin (246) or placebo (122). More patients prematurely withdrew on oxybutynin (23%) than with tolterodine (10.4%) or placebo (16.4%). After 12 weeks of treatment, the median number of incontinence episodes/week was reduced significantly more in the tolterodine (79%; P= 0.0027) and oxybutynin groups (76.5%; P= 0.0168) than on placebo (46.4%). There were also significantly greater improvements in the number of voids/24 h and volume voided/void with tolterodine and oxybutynin than with placebo. More patients in the tolterodine and oxybutynin than in the placebo groups reported improvements in perceived bladder condition, ability to hold urine and treatment benefit. Patients treated with oxybutynin reported more adverse events than those treated with tolterodine or placebo. Dry mouth was significantly more common with oxybutynin than with tolterodine (53.7% vs. 33.5%; P < 0.001), and occurred in 9.8% of placebo patients. CONCLUSION: Tolterodine ER has similar efficacy but is better tolerated than oxybutynin IR in Japanese and Korean patients with OAB.

Adult↗

PubMed2005

Managing patients with an overactive bladder and glaucoma: a questionnaire survey of Japanese urologists on the use of anticholinergics.

OBJECTIVES: To establish the views of urologists on the use of anticholinergic drugs for treating the overactive bladder (OAB) in patients with glaucoma. SUBJECTS AND METHODS: In February 2004 a self-description questionnaire was mailed to all 417 urologists who were members of the Tokai Society of Voiding Dysfunction, to determine current practice in Japan for patients with an OAB and glaucoma. Subgroups were analysed between the types of practice and the duration since the urologists had graduated from medical school. RESULTS: Of the 155 respondents, 76 (49%) routinely enquired about a history of glaucoma before prescribing anticholinergics, and 45 (29%) routinely referred patients with such a history to ophthalmologists. To treat patients with OAB and glaucoma, 102 (66%) would prescribe anticholinergics if permission were available from the ophthalmologist, 33 (21%) chose other treatments and 17 (11%) abandoned treatment. Forty-nine urologists (32%) were currently prescribing anticholinergics to patients with glaucoma. As to knowledge about glaucoma, 132 (85%) urologists knew that there were two types of glaucoma and 98 (63%) knew about laser iridotomy. The proportion of urologists who knew of the two types of glaucoma and asked patients for this information was significantly higher in university than in general hospitals (P < 0.05). CONCLUSIONS: Although anticholinergic drugs can precipitate angle-closure glaucoma by pupillary block, they are not contraindicated in open-angle glaucoma or in angle-closure glaucoma that has already been treated by laser iridotomy. Not all urologists are aware of this difference, at least in Japan. Some urologists avoid anticholinergics in all patients with glaucoma, while others pay little attention to glaucoma. Routine history taking and referral to ophthalmologists allows many patients with OAB and glaucoma to benefit safely from anticholinergics. Moreover, clinicians should be aware of patients with OAB who have not been evaluated by ophthalmologists but who are at risk of angle-closure glaucoma.

Attitude of Health Personnel↗

PubMed2005

Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter study.

PURPOSE: We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder (OAB) and benign prostatic obstruction. MATERIALS AND METHODS: Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction (Abrams-Griffith score greater than 20) were randomized (1:2) into 2 groups, namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation (4 mg once daily) only and group 2-propiverine hydrochloride (20 mg once daily) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen. RESULTS: A total of 211 men, including 69 in group 1 and 142 in group 2, were treated and 198 (93.8%) completed the 8 weeks of treatment. Significant improvements were noted in each group after treatment in urinary frequency, maximum flow rate, average micturition volume and International Prostate Symptom Score. Compared with group 1 improvement rates with regard to urinary frequency (23.5% vs 14.3%, p = 0.004), average micturition volume (32.3% vs 19.2%, p = 0.004), and storage (41.3% vs 32.6%, p = 0.029) and urgency (p = 0.019) International Prostate Symptom Score symptoms were more significant in group 2. Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention. Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 (p = 0.002). Overall adverse event rates were higher in group 2 (p = 0.002), although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups. CONCLUSIONS: This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction.

Adrenergic alpha-Antagonists↗

PubMed2006

Effects of intravesical instillation of cyclooxygenase-2 inhibitor on the expression of inducible nitric oxide synthase and nerve growth factor in cyclophosphamide-induced overactive bladder.

OBJECTIVE: To examine the effects of intravesical cyclooxygenase-2 (COX-2) inhibitors on the expression of inducible nitric oxide synthase (iNOS) and nerve growth factor (NGF) in cyclophosphamide (CYP)-induced overactive bladder (OAB). MATERIALS AND METHODS: In all, 40 Sprague-Dawley rats were divided into control, OAB, and COX-2 inhibitor-treated groups. OAB was induced by an intraperitoneal injection with CYP. Cystometry was performed in all rats and, in half of the OAB rats, a COX-2 inhibitor was administered intravesically. The bladders of all rats were stained immunohistochemically for iNOS and NGF. RESULTS: In the OAB rats, the contraction interval and intercontraction interval were significantly shorter than in control rats, and the contraction time and pressure were significantly greater. In the COX-2 inhibitor-treated rats, the contraction interval and intercontraction interval were significantly longer than in the OAB rats, and the contraction time was significantly shorter. On immunohistochemical staining, there was no iNOS activity and NGF activity was minimally localized in the mucosa and submucosa in the control group. In the OAB rats, NGF activity in the mucosa and submucosa were increased, and there was greater expression of iNOS in all layers and of NGF in detrusor; in the COX-2 inhibitor-treated rats, their expression was less in all layers. CONCLUSIONS: Intravesical instillation with COX-2 inhibitors can reduce CYP-induced bladder hyperactivity and expression of iNOS and NGF. Intravesical instillation with COX-2 inhibitors can be considered as a possible treatment for OAB.

Animals↗

PubMed2003

Transdermal therapy for overactive bladder: present and future.

Transdermal delivery of certain pharmacologic agents offers distinct advantages, including the ability to bypass the gastrointestinal environment, fewer side effects, and increased bioavailability. For many patients with overactive bladder (OAB), transdermal therapy is more convenient than oral therapy, and the altered drug metabolism offers the advantages of an improved side-effect profile and enhanced steady-state plasma concentrations. The "newness" of transdermal delivery to physicians treating OAB is a potential limitation; however, much insight can be gained from the successful use of transdermal systems for delivery of other therapies, such as agents for chronic pain, hormone replacement therapy, and contraceptives. The transdermal oxybutynin system for OAB reduces the level of oxybutynin metabolites, resulting in a low incidence of anticholinergic side effects, and provides efficacy similar to that of standard doses of currently available oral preparations. However, there is room for improvement of the transdermal system, especially with respect to providing increased efficacy over currently available oral medications and reducing and treating local skin reactions at the application site.

Journal Article↗

PubMed2006

The effects of antimuscarinics on health-related quality of life in overactive bladder: a systematic review and meta-analysis.

The objective of this study was to review the effects of antimuscarinic treatments on health-related quality of life (HRQL) in patients with overactive bladder (OAB). MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and the Cumulative Index to Nursing and Allied Health Literature databases were searched from 1966 through August 2004 for randomized controlled trials of antimuscarinic agents. HRQL data from included trials were extracted, and meta-analysis was performed where possible. Of 56 trials included, 25 (45%) reported HRQL and/or patient-reported outcomes. The most commonly used instruments were the Incontinence Impact Questionnaire (3 trials), the King's Health Questionnaire (KHQ; 5 trials), the Medical Outcomes Study Short Form-36 (2 trials), the Gaudenz Appraisal Questionnaire (3 trials), and the Urogenital Distress Inventory (2 trials). Results from the meta-analyses of placebo-controlled trials showed statistically significant differences in favor of antimuscarinic therapy. Differences in HRQL as assessed using the KHQ were also clinically meaningful. The meta-analysis results of active-controlled trials did not show significant differences among antimuscarinic agents. This review provides evidence that antimuscarinics provide an HRQL benefit to patients with OAB. HRQL outcomes using validated instruments are recommended for inclusion in active-controlled trials, and agreement on the most appropriate HRQL instrument is now required.

Controlled Clinical Trials as Topic↗

PubMed2004

Oxybutynin extended-release: a review of its use in the management of overactive bladder.

The OROS-based oxybutynin extended-release (ER) formulation (Lyrinel XL; Ditropan XL) represents a new form of oral delivery for oxybutynin, a muscarinic receptor antagonist used in the treatment of overactive bladder (OAB). The release of oxybutynin from oxybutynin ER occurs in a sustained manner, resulting in a smoother plasma concentration-time profile and a lower maximum plasma concentration than those seen with oxybutynin immediate-release (IR). The ER formulation has been developed with the aim of improving the tolerability of oxybutynin therapy and facilitating once-daily administration. Moreover, oxybutynin ER offers greater flexibility in dosage (5-30 mg/day) than the other available treatment options. At dosages of 5-30 mg once daily, oxybutynin ER produced significant decreases from baseline in weekly urinary urge incontinence in patients with OAB. In addition, there were significant decreases in weekly total incontinence episodes and micturition frequency. In two randomised, double-blind studies in patients with OAB, the improvement in all the symptoms with once-daily oxybutynin ER 5-30 mg/day was similar to that produced by oxybutynin IR 5-20 mg/day given one to four times daily. Once-daily oxybutynin ER 10 mg was superior to tolterodine IR 4 mg/day given as two daily doses and as effective as once-daily tolterodine ER 4 mg/day in decreasing urinary incontinence; the decreases in micturition frequency with oxybutynin ER were significantly greater than those seen with either of tolterodine formulations. Oxybutynin ER was well tolerated in all the trials, with adverse events usually being mild to moderate and transient. In direct comparisons, the overall tolerability profile of oxybutynin ER was better than that of oxybutynin IR. Oxybutynin ER was similar to tolterodine (IR and ER) with respect to the incidence of clinically important dry mouth. A large 12-month tolerability study demonstrated no significant risks associated with the long-term use of oxybutynin ER. A few noncomparative studies have shown promising results with oxybutynin ER in the treatment of adult and paediatric patients with neurogenic bladder dysfunction secondary to neuronal injury. Long- and short-term studies have reported significant improvements in health-related quality of life with oxybutynin ER therapy. In addition, pharmacoeconomic studies have suggested that oxybutynin ER is more cost effective than oxybutynin IR and at least as cost effective as tolterodine IR. In conclusion, oxybutynin ER shows excellent efficacy in the treatment of symptoms associated with OAB in adults and the elderly with a good tolerability profile over a prolonged period of use (12 months). The ER formulation of oxybutynin provides a smooth plasma concentration profile over the 24-hour dosage interval, facilitating once-daily administration. Hence, given its overall efficacy/tolerability profile and dosage flexibility, oxybutynin ER provides an excellent treatment option in the first-line pharmacotherapy of OAB.

Administration, Oral↗

PubMed2004

Reliability and validity of King's Health Questionnaire in patients with symptoms of overactive bladder with urge incontinence in Japan.

AIMS: The purpose of this study is to evaluate the psychometric properties of the Japanese version of the King's Health Questionnaire (KHQ) in patients with symptoms of overactive bladder (OAB) with urge incontinence. METHODS: Data from a 12-week, randomized, double-blind, placebo-controlled clinical trial comparing tolterodine with oxybutynin in patients with symptoms of OAB in Japan were analyzed. Cronbach's alpha coefficient was calculated as a reliability index. Inter-domain correlation was calculated for convergent and discriminant validity assessment. A factor analysis was conducted to explore the underlying factor structure of the KHQ. Sensitivity to clinical change was also evaluated. RESULTS: The psychometric properties and clinical validity of the KHQ Japanese version were confirmed in this study population, and were similar between males and females. The KHQ's good reliability was evidenced by Cronbach's alpha coefficients of >0.60, indicating reasonable consistency except for the personal relationship domain in males (0.47) and severity (coping) measure domain in females (0.59). Discriminant, convergent, and construct validity of the KHQ were also good, with the factor analysis identifying those factors which the KHQ was intended to measure. Finally, KHQ domains were generally responsive to clinical efficacy variables; the KHQ also showed statistically significant sensitivity to change in patients' perception of bladder condition in all domains, except General Health Perception. CONCLUSIONS: Our analyses confirm psychometric properties and clinical validity of the KHQ Japanese version, which appears to offer a valid and reliable HRQoL instrument for use in clinical trials of antimuscarinics in Japan.

Adult↗

PubMed2005

Overactive bladder in the male patient: epidemiology, etiology, evaluation, and treatment.

The urologist's approach to the diagnosis and treatment of lower urinary tract symptoms (LUTS) in male patients has changed significantly over the past decade. Advances in the basic science arena combined with a wealth of clinical data have pointed to the importance of bladder pathophysiology in the development of urinary symptoms. Historically, men with LUTS were diagnosed with "prostatism," an all-encompassing term that includes both voiding and storage symptoms that may or may not be related to prostatic obstruction. Parallel to the scientific advances in the field, the urologic lexicon began to evolve and has allowed us to more specifically describe, and therefore investigate and treat, different aspects of male LUTS. It is now well recognized that many men suffer from storage symptoms that may be more related to bladder dysfunction than to prostatic obstruction. It will be critical to integrate our knowledge of prostatic growth and obstruction, the bladder response to outlet obstruction, environmental and lifestyle factors, and age-related changes to fully understand the complex pathophysiology of male LUTS, specifically overactive bladder syndrome.

Algorithms↗

PubMed2004

Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder.

OBJECTIVE: To assess in a phase 3a trial the efficacy of solifenacin succinate, a once-daily oral antimuscarinic agent in development at 5-mg and 10-mg dosage strengths, for the treatment of overactive bladder (OAB) (Yamanouchi Pharmaceutical Co. Ltd, Tokyo, Japan) compared with placebo in patients with symptoms of OAB, i.e. urgency, incontinence, and frequency, with additional objectives being to assess the safety and tolerability of solifenacin and to compare the efficacy and safety of solifenacin with tolterodine 2 mg twice daily. PATIENTS AND METHODS: The study was an international, multicentre, randomized, double-blind, tolterodine- and placebo-controlled trial conducted at 98 centres. Adult patients with symptomatic OAB for > or = 3 months were eligible; after a single-blind 2-week placebo run-in period patients were randomized equally to a 12-week double-blind treatment with either tolterodine 2 mg twice daily, placebo, solifenacin 5 mg or 10 mg once daily. Efficacy variables included change from baseline in the mean number of urgency, incontinence and urge incontinence episodes, and change from baseline in voids/24 h and mean volume voided/void. RESULTS: In all, 1281 patients were enrolled, 1081 randomized and 1077 treated; 1033 were evaluated for efficacy. Compared with placebo, the change from baseline (-1.41, -32.7%) in the mean number of urgency episodes per 24 h was statistically significantly lower with solifenacin 5 mg (-2.85, -51.9%) and 10 mg (-3.07, -54.7%; both P < 0.001), but not with tolterodine (-2.05, -37.9%; P = 0.0511). There was a statistically insignificant decrease in episodes of incontinence with tolterodine (-1.14; P = 0.1122) but a significant decrease in patients treated with solifenacin 5 (-1.42; P = 0.008) and 10 mg (-1.45; P = 0.0038). Compared with placebo (-1.20, -8.1%) the mean number of voids/24 h was significantly lower in patients receiving tolterodine (-1.88, -15%; P = 0.0145), solifenacin 5 (-2.19, -17%) and 10 mg (-2.61, -20%; both P < 0.001). The mean volume voided/void was also significantly higher with all three active treatments (P < 0.001). Solifenacin was well tolerated; compared with placebo (4.9%), dry mouth (the most common side-effect), mostly mild, was reported in 18.6% of patients receiving tolterodine, 14.0% receiving 5 mg and 21.3% receiving 10 mg solifenacin. CONCLUSION: Solifenacin 5 and 10 mg once daily improved urgency and other symptoms of OAB, and was associated with an acceptable level of anticholinergic side-effects. Solifenacin demonstrated significantly favourable efficacy to side-effect ratio in treating symptomatic OAB.

Administration, Oral↗

PubMed2006

[Intravesical therapy for overactive bladder].

INTRODUCTION: Despite recent advances in the field of anticholinergic drugs, lack of efficiency and side effects are still the main reasons for discontinuation of treatment. The introduction of botulinum A toxin was a milestone in the treatment of detrusor overactivity. The treatment, however, is invasive, the duration of the treatment effects is limited, and long-term results are not yet available. The following addresses therapeutic alternatives to local treatment of overactive bladder. MATERIALS AND METHODS: A total of 52 patients received intravesical oxybutynin. In 16 patients, capsaicin was instilled in the bladder and 28 patients were treated with EMDA. RESULTS: Intravesical oxybutynin was successful in 86%; the success rate of capsaicin instillation was 47%. EMDA was successful in 78%. Two transient ischemic attacks following EMDA were observed as significant side effects. CONCLUSION: Besides botulinum A toxin, several effective treatment options are available for patients with detrusor overactivity refractory to oral anticholinergic treatment. Therefore, in each individual patient, possible risks and complications of the different treatment options should be considered thoroughly to find the optimal method in each case.

Administration, Intravesical↗

PubMed1999

Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder.

This study compared the clinical efficacy (determined from micturition diaries) and safety of 12 weeks' treatment with either tolterodine 2 mg twice daily, oxybutynin 5 mg three times daily or placebo in patients with an overactive bladder. A total of 277 patients were randomized and treated at 25 centers. Both tolterodine and oxybutynin significantly increased volume voided/micturition compared to placebo. Both treatment groups evoked greater decreases in micturitions per 24 hours and incontinence episodes per 24 hours compared to placebo; however, only tolterodine was significantly better than placebo in reducing micturition frequency. Tolterodine and oxybutynin were equivalent in their effectiveness. Tolterodine was significantly better tolerated than oxybutynin when adverse events (particularly frequency and intensity of dry mouth), dose reduction and patient withdrawals were considered. Oxybutynin is an effective drug whose frequent adverse effects limit its clinical usefulness. Tolterodine has equivalent efficacy to oxybutynin, but with less severe adverse effects. This will allow patients to receive more effective treatment for their condition, with better compliance.

Adult↗