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PubMed1978

The role of adjunctive drug therapy for intermittent catheterization and self-catheterization in children with vesical dysfunction.

Thirty-nine children with vesical dysfunction were managed with clean intermittent catheterization. Most children achieved effective urinary continence, the majority with the help of adjunctive drug therapy to relax the detrusor, contract the bladder neck or both. Intermittent catheterization had a generally favourable effect on infection, reflux and hydronephrosis. Intermittent catheterization in childhood is a perferred alternative to urinary diversion in cases of neurogenic bladder dysfunction.

Adolescent↗
PubMed2001

Clinical experiences with tolterodine.

Tolterodine is the first muscarinic receptor antagonist that has been specifically developed for the treatment of overactive bladder. The objectives in the discovery program were to design a potent muscarinic receptor antagonist that is equipotent to oxybutynin in the bladder, but less potent in salivary glands, with the aim of improving tolerability (less dry mouth) in patients with overactive bladder. Tolterodine is non-selective with respect to the muscarinic M1-M5 receptor subtypes, but has a greater effect on the bladder than on salivary glands in vivo, in both animals and humans. Clinical results show that the efficacy and safety of tolterodine in overactive bladder is equal to that of oxybutynin, but that tolterodine is significantly better tolerated by the patients.

Animals↗
PubMed2001

Effects of AH-9700, (+)-pentazocine, DTG and oxybutynin on micturition in anesthetized rats with acetone-induced cystitis.

We investigated the effects of AH-9700 (1-[2-(3,4-dihydro-6,7-dimethyl-2-naphthalenyl)ethyl] pyrrolidine fumarate; a novel sigma receptor ligand), (+)-pentazocine and 1,3-di-o-tolylguanidine (DTG) (two typical sigma receptor ligands), and oxybutynin (a currently used anti-pollakiuria drug) on cystometrograms in anesthetized rats with 30% acetone-induced cystitis. Compared to sham-treated rats, acetone-treated cystitis models exhibited an increase in urinary frequency during continuous filling cystometry. Intravenous administration of AH-9700 (1-5 mg/kg), (+)-pentazocine or DTG to the rats with cystitis dose-dependently prolonged micturition intervals and increased the micturition threshold pressure. Oxybutynin (1 mg/kg. i.v.) also extended micturition intervals, but decreased the micturition pressure. These results indicate that AH-9700, (+)-pentazocine and DTG improve abnormal frequent urination caused by acetone-induced cystitis in a manner different from that of oxybutynin.

Acetone↗
PubMed1984

Methenamine mandelate with acidification: an effective urinary antiseptic in patients with neurogenic bladder.

We studied the effectiveness of methenamine mandelate in preventing urinary tract infection in patients with neurogenic bladder dysfunction who were in a program of intermittent catheterization and bladder retraining. Nine of 17 patients (53%) became infected while receiving the drug, whereas 19 of 22 patients (86%) in a placebo group became infected during the trial. The difference in infection rates was statistically significant (P less than 0.02) and resulted primarily from the absence of gram-positive cocci and Pseudomonas species in the drug group.

Adolescent↗
PubMed2000

Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence. The Ditropan XL Study Group.

OBJECTIVE: To compare the efficacy and safety of controlled-release oxybutynin with conventional, immediate-release oxybutynin and determine rates of dry mouth. METHODS: Patients (n = 226) who were known to be responsive to anticholinergic therapy and who had seven or more urge incontinence episodes per week were randomized to receive controlled-release oxybutynin or immediate-release oxybutynin. After an initial placebo run-in period, dosing in each began at 5 mg per day and increased weekly by 5 mg per day to a maximum of 20 mg per day or when a balance between improvement of incontinence symptoms and tolerability of side effects was achieved. Rates of urge incontinence and dry mouth were compared. Post hoc Kaplan-Meier survival analysis was used to describe elimination of incontinence episodes by dose and to analyze dry mouth risk by dose. RESULTS: Reductions in urge urinary incontinence episodes from baseline to the end of treatment were 18.6 to 2.9 per week (83% mean decrease) and 19.8 to 4.4 per week (76% mean decrease) in the controlled- and immediate-release oxybutynin groups (P =.36), respectively. At equal doses, comparable proportions of patients in both groups reported the absence of urge incontinence (P =.85). The incidence of dry mouth increased with dose in both groups, but there was no difference in dry mouth rates between the groups: 47.7% and 59.1% for the controlled- and immediate-release oxybutynin (P =.09), respectively. However, Kaplan-Meier analysis to examine first report of dry mouth at a given dose revealed that a significantly lower proportion of patients taking controlled-release oxybutynin had moderate to severe dry mouth (P =.007) or any dry mouth (P =.003) compared with those taking immediate-release oxybutynin. CONCLUSION: At the same daily dose, controlled- and immediate-release oxybutynin demonstrated comparable efficacy in reduction of urge incontinence episodes. The incidence of dry mouth was dose dependent but equal in both groups; first report of moderate to severe dry mouth was significantly lower in the controlled-release group.

Chemistry, Pharmaceutical↗
PubMed2000

Absorption of oxybutynin from vaginal inserts: drug blood levels and the response of the rabbit bladder.

OBJECTIVES: Oxybutynin has been used for treatment of urge urinary incontinence for more than 20 years. However, one of the major problems with its use is uncomfortable anticholinergic side effects that can lead to discontinuation of treatment. Alternative forms of drug administration may reduce side effects and thus improve patient compliance. METHODS: A cylinder-shaped, curved silicone elastomer insert containing oxybutynin was anchored in the vagina of female rabbits. The inserts were designed to release oxybutynin at rates of 0.5, 1.0, and 5.0 mg/day, respectively. Blood drug and metabolite levels were monitored for 1 to 7 days and cystometry was carried out after 7 days of treatment. RESULTS: There was a consistent dose-dependent absorption of the oxybutynin resulting in stable plasma concentrations by 3 days. Levels of N-desethyloxybutynin, the active metabolite that is thought to be responsible for side effects, were less than 1.0 ng/mL in all groups. The cystometrograms showed a decrease in the detrusor pressures for the higher oxybutynin groups and a dose-dependent decrease in micturition pressure. The vaginal wall in contact with the insert showed no irritation. CONCLUSIONS: The inserts produced stable blood levels and released sufficient amounts of oxybutynin to have measurable effects on the bladder. There was no irritating effect of the insert on the vaginal wall after a 1-week treatment. Vaginal inserts containing oxybutynin may be an interesting alternative method for the chronic delivery of oxybutynin.

Absorption↗
PubMed2000

Advancements in pharmacologic management of the overactive bladder.

Continued developments in the understanding of lower urinary tract function have led to improvements in the pharmacologic manipulation of bladder dysfunction. Drug delivery changes have produced drugs that provide better efficacy and tolerability, thus improving patient compliance. Improvements in drug delivery systems have altered drug bioavailability and pharmacokinetics. Active current investigation in new agents and delivery systems for intravesical delivery has yielded intriguing early results that may substantially add to the armamentarium for the management of the overactive bladder (urgency, frequency, urge incontinence). New developments in the understanding of the neuropharmacology of the bladder, peripheral pelvic nerves, and sacral cord may provide agents with entirely new drug effects, either as primary agents or agents to be used in combination with currently available drugs. We herein review newer agents and drug delivery systems.

Adrenergic alpha-Antagonists↗
PubMed2002

Preliminary study of the safety and efficacy of extended-release oxybutynin in children.

OBJECTIVES: To test the safety and efficacy of extended-release oxybutynin in children with bladder dysfunction. The efficacy of oxybutynin in children has been limited by side effects. A new extended-release formulation of oxybutynin has some benefits versus traditional oxybutynin but has never been evaluated in children. METHODS: A retrospective study was performed on 25 children who had been treated with extended-release oxybutynin. Fourteen had neurogenic bladder dysfunction and 11 had urinary frequency and urgency and urge incontinence but no neurologic abnormalities. Patients and families were asked to semiquantitatively (0 to 10 grading with 10 = severe) assess the effects of the medication on efficacy, as well as side effects and compliance with medication schedules. RESULTS: All 25 patients had improvement in incontinence and/or voiding dysfunction on extended-release oxybutynin. Twelve (48%) experienced no side effects. Of the 13 who did, 10 complained of dry mouth (grade 4.6 plus minus 0.5), 4 had constipation (grade 5.8 plus minus 1.8), 4 had heat intolerance (grade 5.1 plus minus 0.9), and 3 had drowsiness (grade 5.3 plus minus 2.4). Of patients previously treated with oxybutynin, the extended-release oxybutynin was equally or more efficacious and had the same or fewer side effects, especially less dry mouth. Families reported much better patient compliance with the medication regimen using extended-release oxybutynin compared with oxybutynin. Patient and family satisfaction was very high, and 21 of 25 have continued using the medication. CONCLUSIONS: Extended-release oxybutynin is safe and efficacious in children. In this preliminary evaluation, it had benefits over traditional, immediate-release oxybutynin.

Adolescent↗
PubMed2002

New perspectives on the overactive bladder: pharmacokinetics and bioavailability.

In the United States alone, approximately 17 million men and women have symptoms of overactive bladder (OAB). For many years, oxybutynin was the drug of choice for treating OAB. Although it provided effective treatment, multiple daily doses were required, and adverse events, such as dry mouth and constipation, were decided drawbacks. Controlled drug delivery systems seen in commercially available OAB formulations alter the pharmacokinetics of antimuscarinic medications in ways that maintain efficacy and allow once-daily dosing and reduction of adverse events. In the future, OAB medications will not only incorporate new chemical entities, such as the S-enantiomer of oxybutynin, but will also use novel drug delivery technologies, including transdermal patches and bladder implants.

Administration, Cutaneous↗
PubMed2002

Future studies of overactive bladder: the need for standardization.

Clinicians and researchers agree that pharmacologic studies of the overactive bladder (OAB) require precise planning, strict adherence to study design, and meticulous attention to study conduct and statistical methods. In addition, there should be straightforward and highly directed formulation of the conclusions derived expressly from data that have been collected. The exact methods to achieve these ends, however, are often debated among statisticians and experts in study design and by physicians who interpret the clinical implications of the findings. For these reasons, the conclusions of clinical research in OAB are commonly criticized on the basis of study objectives, study design, statistical methods, or conclusions. However, a subtler, but possibly more critical problem exists: the method of defining the population and the methods for collecting the data for the efficacy outcome parameters, including frequency, urgency, and urge incontinence.

Adult↗
PubMed2002

Value of increase in bladder capacity in treatment of refractory monosymptomatic nocturnal enuresis in children.

OBJECTIVES: To evaluate children with refractory monosymptomatic nocturnal enuresis to determine whether detrusor overactivity (DOA) plays a role in 4 weeks of unsuccessful treatment with retention control training (RCT); whether an increase in bladder capacity can eventually be obtained by RCT plus oxybutynin; and whether the increase in capacity is the primary key to success. METHODS: Sixty-eight children with refractory monosymptomatic nocturnal enuresis were included. They all had a maximal cystometric capacity less than the age-expected value. RCT was done by water loading and retention to the point of urgency once daily. During training, changes in bladder capacity were evaluated by voiding charts. If after 4 weeks of RCT, less than a 10% increase in bladder capacity was noted, oral oxybutynin was added. RESULTS: The incidence of DOA was 66%. After 4 weeks of RCT, the bladder capacity increased in 20.6%. Combining RCT with oxybutynin led in the end to normalization of the bladder capacity in 79.4%. Older age and high-pressure DOA negatively influenced the ability to increase the bladder capacity. Fifteen children became completely dry, mainly by converting enuresis to nocturia. CONCLUSIONS: Unsuccessful RCT is often caused by DOA, especially if a bladder capacity rise of at least 10% cannot be achieved within 4 weeks. If oxybutynin is added to the treatment, normalization of bladder capacity can be obtained in most. This increased bladder capacity cures enuresis only in a minority by sharpening their arousal and provoking nocturia.

Administration, Oral↗