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PubMed1998

Biotransformation of tolterodine, a new muscarinic receptor antagonist, in mice, rats, and dogs.

Tolterodine is a new muscarinic receptor antagonist intended for the treatment of urinary urge incontinence and other symptoms associated with an overactive bladder. The in vivo metabolism of 14C-labeled tolterodine was investigated in rats, mice, and dogs by analysis of blood and urine samples, whereas in vitro metabolism studies were performed by incubation of [14C]tolterodine with mouse, rat, dog, and human liver microsomes in the presence of NADPH. Tolterodine was extensively metabolized in vivo. Mice and dogs showed similar metabolite patterns, which correlated well with that observed in humans. In these species, tolterodine was metabolized along two different pathways, with the more important being the stepwise oxidation of the 5-methyl group to yield the 5-hydroxymethyl metabolite of tolterodine and then, via the aldehyde, the 5-carboxylic acid metabolite. The other pathway involved dealkylation of the nitrogen. In the subsequent phase II metabolism, tolterodine and the metabolites were conjugated with glucuronic acid to various degrees. Rats exhibited more extensive metabolism and a markedly different metabolite pattern, with metabolites also being formed by hydroxylation of the unsubstituted benzene ring. In addition, a gender difference was observed, with male rats showing more extensive metabolism than females. Incubation of [14C]tolterodine with liver microsomes yielded a total of five metabolites with rat liver microsomes and three with mouse, dog, and human liver microsomes. The 5-hydroxymethyl metabolite of tolterodine and N-dealkylated tolterodine were major metabolites in all incubations, representing 83-99% of total metabolism. Although the extent of metabolism varied among species, the metabolic profiles were similar. However, rat liver microsomes also formed metabolites hydroxylated in the unsubstituted benzene ring. These results show that the metabolism of tolterodine in mice and dogs corresponds to that observed in humans, whereas rats exhibit a different metabolite pattern.

Animals↗
PubMed2006

Safety and tolerability of tolterodine for the treatment of overactive bladder in men with bladder outlet obstruction.

PURPOSE: Antimuscarinic therapy for men with OAB and BOO is perceived as a potential risk for urinary retention. Using pressure flow urodynamics, we evaluated the safety of tolterodine vs placebo in men with OAB and BOO. MATERIALS AND METHODS: Men (older than 40 years) with BOO and confirmed detrusor overactivity were randomized to tolterodine (2 mg twice daily in 149) or placebo (in 72) for 12 weeks. Primary end points were Qmax and pdetQmax. RESULTS: Median treatment differences in Qmax (-0.7 ml per second, 95% CI -1.6 to 0.4) and pdetQmax (-7 cm H2O, 95% CI -3 to 11) were comparable. Tolterodine significantly reduced the BOOI vs placebo (-9 vs 0, p < 0.02). There were significant treatment differences in volume to first detrusor contraction (+59 ml, 95% CI 19-100) and maximum cystometric capacity (+67 ml, 95% CI 35-103), favoring tolterodine over placebo (p < 0.003). Change in PVR was significantly greater among patients treated with tolterodine (+25 ml) than placebo (0 ml, p < 0.004). There were no significant between-group differences in the incidence of adverse events. Urinary retention was reported by 1 patient treated with placebo. CONCLUSIONS: Tolterodine did not adversely affect urinary function in men with OAB and BOO. Urinary flow rate was unaltered, and there was no evidence of clinically meaningful changes in voiding pressure and PVR or urinary retention. Tolterodine was well tolerated. These results suggest that antimuscarinics can be safely administered in men with BOO.

Aged↗
PubMed2006

How do the prevalences of urogenital symptoms change during pregnancy?

AIM: The aim of this study was to report the changes in prevalences of urogenital symptoms during pregnancy and to evaluate the amount of bother nulliparous pregnant women experience from these symptoms. METHODS: We have used a prospective longitudinal cohort study design. Five hundred fifteen nulliparous women with a singleton pregnancy were recruited from 10 midwifery practices between January 2002 and July 2003. The women received postal questionnaires. Urogenital symptoms were assessed with the Dutch version of the standardized and validated Urogenital Distress Inventory (UDI). We analyzed our data on item level and on the clustering of items. RESULTS: The prevalences of the frequency and urgency symptoms are high at 12 weeks (74% and 63%) and remain stable during pregnancy. The prevalences of urinary incontinence and voiding difficulties increase with gestational age. Frequency disappears in 12% in late pregnancy, urgency in 22%, and stress incontinence in 23%. The prevalence of bothersome frequency symptoms is much higher than of urinary incontinence (21% compared to 6%). All UDI subscales increase significantly during pregnancy. CONCLUSIONS: Urogenital symptoms occur in almost all women during pregnancy. Whereas the prevalence of overactive bladder symptoms is high and remains stable from early pregnancy on, the prevalences of urinary incontinence symptoms increase with gestational age. Despite the high prevalences of symptoms, the majority of women report not to be bothered by it.

Adult↗
PubMed2003

A review of the L-arginine - nitric oxide - guanylate cyclase pathway as a mediator of lower urinary tract physiology and symptoms.

Lower urinary tract symptoms (LUTS) are common and costly conditions that affect millions of men and women worldwide. A focal area of research into the cause and potential treatment of LUTS is the nitric oxide pathway, which is involved in nerve-induced relaxation in the lower urinary tract. Isoforms of NOS, including nNOS, eNOS, and iNOS, have been identified in the lower urinary tract of both animals and humans. Nerves that are immunoreactive to nitric oxide synthase (NOS) mainly serve the bladder outlet region, but some serve the detrusor. Pathology of the l-arginine-nitric oxide-cGMP pathway involving nNOS and eNOS may lead to impaired relaxation of the urethral outlet, increased bladder afferent activity, and detrusor smooth muscle overactivity. Such pathology has been implicated in the conditions of detrusor instability, urinary incontinence and outlet obstruction. iNOS may play an important role in inflammatory and infectious conditions of the bladder. Strategic manipulation of nitric oxide (NO), or interventions that address its mechanisms of action, possibly by pharmacological means or with gene therapy, may restore function or produce desired functional effects in the lower urinary tract.

Arginine↗
PubMed2002

Special considerations of the overactive bladder in children.

The overactive bladder (OAB) in children is defined as both involuntary detrusor contractions and urethral instability. The development of urinary control plays a key role in its incidence and in our understanding of its pathogenesis. It is seen in a number of conditions but by far is most common among patients with dysfunctional voiding. Urinary infection can be both a cause and an effect of OAB. In some instances, vesicoureteral reflux may result from detrusor overactivity because its successful resolution has been shown to depend on abolition of the hyperactivity. Early diagnosis and appropriate treatment can affect upper urinary tract function and drainage and ultimate bladder function. Recognition is noted via a thorough history and careful physical examination. Urodynamic assessment is indicated in neurologically normal children >5 years old and is combined with a voiding cystourethrogram in boys and a radionuclide cystogram in girls who have a history of recurrent urinary infection. Treatment consists of prophylactic use of anticholinergic agents in patients with neurologic dysfunction, as an early adjunctive measure in boys after ablation of posterior urethral valves, and in children with vesicoureteral reflux. The dose must be carefully titrated in children with cerebral palsy to prevent the appearance of elevated residual urine. Behavioral therapy and biofeedback techniques are effective alternatives to anticholinergic agents for children with dysfunctional voiding.

Adolescent↗
PubMed2004

Development of the first ultra-potent "capsaicinoid" agonist at transient receptor potential vanilloid type 1 (TRPV1) channels and its therapeutic potential.

Olvanil (N-9-Z-octadecenoyl-vanillamide) is an agonist of transient receptor potential vanilloid type 1 (TRPV1) channels that lack the pungency of capsaicin and was developed as an oral analgesic. Vanillamides are unmatched in terms of structural simplicity, straightforward synthesis, and safety compared with the more powerful TRPV1 agonists, like the structurally complex phorboid compound resiniferatoxin. We have modified the fatty acyl chain of olvanil to obtain ultra-potent analogs. The insertion of a hydroxyl group at C-12 yielded a compound named rinvanil, after ricinoleic acid, significantly less potent than olvanil (EC(50) = 6 versus 0.7 nM), but more versatile in terms of structural modifications because of the presence of an additional functional group. Acetylation and phenylacetylation of rinvanil re-established and dramatically enhanced, respectively, its potency at hTRPV1. With a two-digit picomolar EC(50) (90 pM), phenylacetylrinvanil (PhAR, IDN5890) is the most potent vanillamide ever described with potency comparable with that of resiniferatoxin (EC(50), 11 pM). Benzoyl- and phenylpropionylrinvanil were as potent and less potent than PhAR, respectively, whereas configurational inversion to ent-PhAR and cyclopropanation (but not hydrogenation or epoxidation) of the double bond were tolerated. Finally, iodination of the aromatic hydroxyl caused a dramatic switch in functional activity, generating compounds that behaved as TRPV1 antagonists rather than agonists. Since the potency of PhAR was maintained in rat dorsal root ganglion neurons and, particularly, in the rat urinary bladder, this compound was investigated in an in vivo rat model of urinary incontinence and proved as effective as resiniferatoxin at reducing bladder detrusor overactivity.

Amidohydrolases↗
PubMed2005

Brain control of normal and overactive bladder.

PURPOSE: Bladder control problems are common but their cause is often unclear. Many investigators have sought causes in the lower urinary tract, but fewer in the supraspinal control system. We have used functional magnetic resonance imaging (fMRI) to determine brain responses to bladder filling in subjects with normal and with poor bladder control (detrusor overactivity). MATERIALS AND METHODS: Cerebral responses to bladder infusion were recorded in 1 male and 11 females without overt neurological abnormality, aged 26 to 83 years. Six had good bladder control and 6 had poor control on prior urodynamics. fMRI was performed while repeatedly infusing and withdrawing liquid into and out of the bladder, and monitoring intravesical pressure. Measurements were made at small and large bladder volumes. RESULTS: fMRI detected activation of many brain regions involved in bladder control, including periaqueductal gray, thalamus, insula, dorsal anterior cingulate, and ventromedial cerebellum. Orbitofrontal cortex, pontine micturition center and preoptic hypothalamus were visible in subgroup analyses. Activations outweighed deactivations and responses became stronger at large bladder volumes. Among subjects with good control, this strengthening of response was prominent in the orbitofrontal cortex. Among those with poor control cortical responses were exaggerated at larger bladder volumes, except in the orbitofrontal cortex, which remained weakly activated. This difference was not due to concurrent detrusor activity. CONCLUSIONS: Poor bladder control is specifically associated with inadequate activation of orbitofrontal cortex. Clinically, frontal cortical lesions cause bladder control problems. This study suggests a similar neurophysiological basis for poor bladder control in the absence of overt neurological lesion.

Adult↗
PubMed2005

Changes in urethral function with bladder filling in the presence of urodynamic stress incontinence and detrusor overactivity.

OBJECTIVE: The purpose of this study was to assess the effect of detrusor overactivity and bladder filling on urethral function with the use of urethral profilometry. STUDY DESIGN: Women with symptoms of urinary incontinence were recruited from our urodynamic clinic. All of the women underwent videocystourethrography and urethral pressure profilometry with the bladder empty and then full. The maximum urethral closure pressure, mean urethral pressure, functional urethral length, and pressure transmission ratios for each quartile were analyzed. RESULTS: Thirty-five women were recruited: 17 women had urodynamic stress incontinence, and 18 women had detrusor overactivity. In women with urodynamic stress incontinence, there was a significant increase in maximum urethral closure pressure and pressure transmission ratios over all quartiles when the bladder was full compared with empty. In women with detrusor overactivity, there was a significant decrease in functional urethral length and pressure transmission ratios in the second and third quartile of the urethral pressure profiles when the bladder was full compared with empty. CONCLUSION: Decreases in functional urethral length and pressure transmission ratios with bladder filling in those women with detrusor overactivity are at variance with the normal physiologic response to bladder filling, which suggests that urethral function is affected by the presence of abnormal detrusor activity and that the valid assessment of urethral function may not be possible if the detrusor overactivity is not treated.

Adult↗
PubMed2002

(-)-(9S)-9-(3-Bromo-4-fluorophenyl)-2,3,5,6,7,9-hexahydrothieno[3,2-b]quinolin-8(4H)-one 1,1-dioxide (A-278637): a novel ATP-sensitive potassium channel opener efficacious in suppressing urinary bladder contractions. II. in vivo characterization.

ATP-sensitive potassium (K(ATP)) channel openers (KCOs) have been shown to inhibit spontaneous myogenic contractile activity of the urinary bladder, a mechanism hypothesized to underlie detrusor instability and symptoms of overactive bladder. However, the therapeutic utility of KCOs has been limited by a lack of differentiation of bladder versus vascular effects. In this study, we evaluated the in vivo potency and bladder selectivity of (-)-(9S)-9-(3-bromo-4-fluorophenyl)-2,3,5,6,7,9-hexahydrothieno[3,2-b]quinolin-8(4H)-one 1,1-dioxide (A-278637), a novel dihydropyridine KCO, in a pig model of detrusor instability secondary to partial bladder outlet obstruction. For comparison, we profiled two KCOs, ((R)-4-[3,4-dioxo-2-(1,2,2-trimethyl-propylamino)-cyclobut-1-enylamino]-3-ethyl-benzonitrile (WAY-133537) and (S)-N-(4-benzoylphenyl)-3,3,3-trifluro-2-hydroxy-2-methyl-propionamide (ZD6169), reported previously to have improved bladder selectivity in vivo and a calcium channel blocker, nifedipine. Effective doses of A-278637, WAY-133537, ZD6169, and nifedipine to inhibit unstable contraction area under the curve by 35% and to decrease mean arterial pressure by 10% were 4.2 and 12, 109 and 51, 661 and 371, and 136 and 30 nmol/kg i.v., yielding corresponding bladder selectivity ratios of 3, 0.5, 0.6, and 0.2. Therefore, A-278637 was approximately 5- to 6-fold more bladder-selective than the other KCOs and 15-fold more selective than nifedipine, the latter approximately 4.5-fold vascular-selective. The potency of KCOs to inhibit unstable contraction in vivo was accurately predicted by their potency to inhibit spontaneous contractile activity of pig detrusor strips in vitro. These results indicate that A-278637, with enhanced potency and bladder selectivity compared with the other compounds evaluated, could serve as a useful tool in the investigation of smooth muscle K(ATP) channel openers as novel therapeutic agents for the treatment of overactive bladder.

ATP-Binding Cassette Transporters↗
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↗
PubMed2006

Bladder dysfunction in Parkinsonism: mechanisms, prevalence, symptoms, and management.

The advent of functional imaging methods has increased our understanding of the neural control of the bladder. This review examines current concepts of the role of brain function in urinary control with particular emphasis on the putative role of dopamine receptors. Dopaminergic mechanisms play a profound role in normal bladder control and the dysfunction of these may result in symptoms of overactive bladder in Parkinsonism. The importance of this nonmotor disorder has been overlooked. We address the problem of bladder dysfunction as it presents to patients and their neurologist. The prevalence of bladder symptoms in Parkinson's disease is high; the most common complaint is nocturia followed by frequency and urgency. In multiple-system atrophy, the combination of urge and urge incontinence and poor emptying may result in a complex combination of complaints. The management of bladder dysfunction in Parkinsonism addresses treatment of overactive detrusor as well as incontinence.

Brain↗
PubMed2005

Does the less aggressive multimodal approach of treating bladder-prostate rhabdomyosarcoma preserve bladder function?

PURPOSE: The treatment of bladder-prostate rhabdomyosarcoma has evolved into multimodal therapy, including chemotherapy, radiotherapy and organ sparing surgery with bladder preservation. We investigated bladder function in children who underwent multimodal therapy at our institution and retained the original bladder for at least 6 months after treatment ended. MATERIALS AND METHODS: We evaluated 8 children with bladder-prostate rhabdomyosarcoma treated at our institution between 1999 and 2003 according to inclusion criteria. All patients underwent history, physical examination and urodynamic study at least 6 months after completion of treatment (range 6 to 39 months). RESULTS: All patients were treated following the same chemotherapy and radiotherapy scheme. Three patients (37.5%) were asymptomatic and had normal urodynamic studies, and 1 had only dysuria (this patient later underwent continent urinary diversion with transverse colon). The 4 remaining patients had urological complaints, and the urodynamic findings were reduced bladder capacity in 4, overactivity plus sensory urgency in 2, sensory urgency only in 1 and suprapubic pain during filling in 1. CONCLUSIONS: Among 8 patients 3 had normal urinary function and 4 had minor tolerable alterations. Cystectomy and urinary diversion were later necessary in only 1 patient due to disabling dysuria. The fact that the original functioning bladder was preserved in 7 of 8 patients suggests the feasibility of multimodal therapy. Long-term followup will still be necessary for definite conclusions, since we recognize that the deleterious effects, mainly of radiotherapy, may take longer to become evident.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2005

Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics.

OBJECTIVES: To investigate the clinical and urodynamic effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity. Intradetrusor injection of botulinum A toxin has been used to treat patients with detrusor overactivity. Suburothelial injection of botulinum A toxin might effectively inhibit the occurrence of detrusor overactivity mediated by sensory nerves. METHODS: Twenty patients with nonneurogenic detrusor overactivity refractory to anticholinergics were enrolled and treated with injection of 200 U botulinum A toxin into the suburothelial space. The clinical effects on the lower urinary tract symptoms and urodynamic parameters were assessed. RESULTS: At 3 months after treatment, 9 patients had regained continence (45%), 8 had improvement (40%), and treatment had failed in 3 (15%). At 6 months after treatment, 7 patients remained continent, but treatment had failed in 5. Hematuria developed in 1 patient, urinary tract infection in 7 (35%), and a large postvoid residual urine volume requiring catheterization in 6 (30%). Hesitancy in initiation and difficult urination was also noted in 15 patients (75%). The volume of the first sensation of bladder filling and bladder capacity increased about two times; however, the voiding efficiency was reduced by 50% at 2 weeks after treatment. The postvoid residual urine volume was increased by seven times the baseline value at 2 weeks and had decreased to three times greater at 3 and 6 months after treatment. CONCLUSIONS: The results of this study have shown that suburothelial injection of 200 U botulinum A toxin impairs bladder sensation and voiding efficiency, but is effective in the treatment of nonneurogenic detrusor overactivity. Transient urinary retention and the development of urinary tract infection should be carefully monitored.

Adult↗
PubMed1987

Vesicoureteral reflux and lower urinary tract dysfunction: evidence for 2 different reflux/dysfunction complexes.

We examined retrospectively 458 children 2 to 15 years old without neuropathic conditions or a gross anatomical abnormality to determine whether there was an association between lower urinary tract dysfunction and vesicoureteral reflux. We identified 2 different types of reflux/dysfunction complexes with contrasting urodynamic characteristics. One type included bladder instability with powerful voiding contractions of the bladder and reflux that frequently occurred on 1 side only. Reflux nephropathy or the presence of an upper urinary tract abnormality is rare. In the other type the bladder contracted poorly during voiding and overactivity of the urethral closure mechanism often was observed. The bladder usually was stable and the reflux occurred frequently on both sides. Reflux nephropathy or the presence of an upper urinary tract abnormality is relatively common. Direct videourodynamic observations of reflux in a second group of children confirmed the existence of these 2 types of reflux/dysfunction complexes.

Adolescent↗
PubMed2006

Tension-free vaginal tape sling procedure for the treatment of stress urinary incontinence in Hong Kong women with and without pelvic organ prolapse: 1-year outcome study.

OBJECTIVE: To assess the outcome of patients who underwent a tension-free vaginal tape sling procedure alone versus patients who underwent concomitant pelvic floor surgery. DESIGN: Retrospective cohort study. SETTING: Urogynaecology unit of a university teaching hospital, Hong Kong. PATIENTS: Patients diagnosed with moderate-to-severe urodynamic stress incontinence and underwent a tension-free vaginal tape sling procedure from September 1999 to August 2004. MAIN OUTCOME MEASURES: Objective cure rate of stress urinary incontinence 1 year following tension-free vaginal tape sling procedure was assessed. Patients were considered objectively cured if no stress urinary incontinence was evident on urodynamic studies at 1-year follow-up. Subjective cure rates at 4 months and 1 year after tension-free vaginal tape sling procedure were also assessed. Other outcome measures included intra-operative and perioperative complication rates, and the rate of de-novo detrusor overactivity at 1 year. RESULTS: Of 302 patients recruited, 250 (82.8%) completed 1-year follow-up. There were 157 (62.8%) patients who had a tension-free vaginal tape sling alone, and 93 (37.2%) had tension-free vaginal tape sling and concomitant pelvic floor surgery for pelvic organ prolapse. All patients had urodynamic studies before and 1 year following surgery. The objective cure rate was 87.3% for patients with tension-free vaginal tape sling alone, and 80.6% for tension-free vaginal tape sling with concomitant procedures (Chi squared test, P>0.05). The subjective cure rates for tension-free vaginal tape sling alone and tension-free vaginal tape sling plus concomitant procedures were 89.2% and 86.0% at 4 months, and 93.0% and 94.6% at 1 year, respectively (Chi squared test, P>0.05). The most common complication was postoperative urinary retention (15.2%), followed by de-novo detrusor overactivity at 1 year (10%), and bladder perforation (8%). CONCLUSION: The tension-free vaginal tape sling procedure alone or in combination with pelvic floor surgery are equally effective for the treatment of female stress urinary incontinence.

Aged↗
PubMed2006

Post-robotic prostatectomy urinary continence: characterization of perfect continence versus occasional dribbling in pad-free men.

OBJECTIVES: To review and characterize two groups of men who report being pad-free after robot-assisted laparoscopic prostatectomy (RLRP): those with occasional incontinence and those with complete control. METHODS: The study included 106 out of a total of 195 men who underwent RLRP. Inclusion requirements were adequate follow-up and no-pad continence status. All patients completed self-administered American Urological Association symptom score (AUAss) and continence questionnaires and underwent measurement of peak urinary flow rates, postvoid residual volumes, and voided volumes (VV) before and 3 months after surgery. All data and standard clinical characteristics were entered prospectively into an electronic database. RESULTS: Two distinct groups reported wearing no pads: the "perfect" group (n = 32) reported never leaking, and the "imperfect" group (n = 74) reported occasional leakage but did not wear pads. Preoperatively, the "imperfect" group was older (62.2 versus 59 years) and had more urinary symptoms (all P < 0.05). Postoperatively, the "imperfect" group took longer to achieve a pad-free status (median 39.8 versus 19.3 days), had larger prostates (mean 50.9 versus 43.2 g), had lower VV (324 versus 405 mL), and more urinary symptoms (AUAss 7.4 versus 4.3; all P < 0.05). CONCLUSIONS: Sixty-nine percent of men who attain "pad-free continence" after RLRP have occasional urinary leakage. Preoperatively, these men are characteristically older and have larger prostates, AUAss, and bother scores. Postoperatively, the "imperfect" group takes longer to achieve pad-free status and has smaller bladder capacities and more urinary symptoms. These results suggest that an overactive detrusor is the likely contributing etiology.

Humans↗
PubMed2002

Clinical impact of overactive bladder.

Overactive bladder (OAB) is a medical condition with the symptoms of urinary frequency and urgency, with or without urge incontinence. Traditionally, epidemiologic studies have focused on the symptom of incontinence, and therefore the prevalence and clinical impact have been grossly underestimated. Recently, several population-based studies have been conducted that have provided insight into the true magnitude of OAB. This article will review the latest data on the prevalence of OAB and discuss the impact of the condition on quality of life. Furthermore, it will examine some of the comorbidities associated with OAB and look at the potential economic impact of OAB.

Journal Article↗