Glycopyrrolate-induced craniofacial compensatory hyperhidrosis successfully treated with oxybutynin: report of a novel adverse effect and subsequent successful treatment.

Hyperhidrosis, or abnormally increased sweating, is a condition that may have a primary or secondary cause. Usually medication- induced secondary hyperhidrosis manifests with generalized, rather than focal sweating. We report a 32-year-old woman with a history of palmoplantar hyperhidrosis for 15 years who presented for treatment and was prescribed oral glycopyrrolate. One month later, the palmoplantar hyperhidrosis had resolved, but she developed new persistent craniofacial sweating. After an unsuccessful trial of clonidine, oxybutynin resolved the craniofacial hyperhidrosis. To our knowledge, this is the first case of compensatory hyperhidrosis secondary to glycopyrrolate reported in the literature. The case highlights the importance of reviewing medication changes that correlate with new onset or changing hyperhidrosis. It also demonstrates a rare drug adverse effect with successful treatment.

Transcutaneous parasacral electrical stimulation vs oxybutynin for the treatment of overactive bladder in children: a randomized clinical trial.

PURPOSE: We determined the effectiveness of 2 methods to treat overactive bladder in children using intragroup and intergroup comparisons in a randomized clinical trial. MATERIALS AND METHODS: Nine boys and 19 girls with a mean ± SD age of 6.4 ± 2.18 years were randomly divided into group 1-parasacral transcutaneous electrical stimulation with placebo drug and group 2-oxybutynin with sham scapular electrical therapy. Success was assessed by 1) the rate of complete symptom resolution, 2) a visual analog scale of 0 to 10, 3) the dysfunctional voiding score system, 4) voiding diary records, 5) Rome III criteria and 6) side effect frequency in each group. RESULTS: A total of 13 and 15 patients were randomized to groups 1 and 2, respectively. Symptoms completely resolved in 6 patients in group 1 (46%) and 3 in group 2 (20%) (p = 0.204). A statistically significant improvement was found in the 2 groups in the dysfunctional voiding score system and voiding diary records. However, no statistically significant difference was found between the groups in the visual analog scale score, voiding frequency, and maximum and mean voided volume (p = 0.295, 0.098, 0.538 and 0.650, respectively). Constipation improved in 100% of group 1 patients but in only 55% in group 2 (p = 0.031 vs 0.073). Group 1 showed no side effects while dry mouth, hyperthermia and hyperemia developed in 58%, 25% and 50% of group 2 patients (p = 0.002, 0.096 and 0.005, respectively). Treatment was discontinued by 13.3% of patients in group 2. CONCLUSIONS: Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children. However, transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects. Oxybutynin was more effective for decreasing voiding frequency.

Remarkable improvement of relapsing dyshidrotic eczema after treatment of coexistant hyperhidrosis with oxybutynin.

Dyshidrotic hand eczema is a common condition, which can be resistant to various treatments. Although a number of etiologic factors are involved in the pathogenesis of dyshidrotic eczema, hyperhidrosis is assumed to play a significant role. Oxybutynin is an alternative treatment for hyperhidrosis. We present the cases of two patients suffering from hyperhidrosis and dyshidrotic eczema, who were treated with oxybutynin with impressive results.

[Intravesical oxybutynin treatment for neurogenic detrusor overactivity : Efficacy and safety data from clinical practice with the first intravesical oxybutynin treatment authorized in Germany]. / Intravesikale Oxybutynin-Behandlung der neurogenen Detrusorüberaktivität : Wirksamkeits- und Sicherheitsdaten aus der Praxis der ersten in Deutschland zugelassenen intravesikalen Oxybutynin-Behandlung.

Existing therapies for neurogenic detrusor overactivity (NDO), i.e. oral anticholinergics and botulinum toxin injections, can be associated with serious adverse effects or are not always sufficiently effective. Therefore, there is a need for alternative safe and effective treatment options for NDO. Intravesical oxybutynin has been successfully used for several years as a prescription drug in adults and children with spinal cord injury and spina bifida. In 2019, VESOXX® (FARCO-PHARMA, Cologne, Germany) became the first registered intravesical oxybutynin product in Germany, which is indicated for the suppression of neurogenic detrusor overactivity (NDO) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterisation (CIC), if they cannot be adequately managed by oral anticholinergic treatment due to lack of efficacy and/or intolerable side effects. Overall, there are limited data regarding therapy with intravesical oxybutynin, with the majority of publications being retrospective case series. To date, there are limited data on the efficacy and safety of the newly approved intravesical oxybutynin therapy (VESOXX®) in NDO patients. This noninterventional case series from daily routine treatment which evaluated the physician reports of 38 patients suggests that intravesical oxybutynin effectively improves maximum detrusor pressure (Pdet max) by decreasing it by 59% from 51.94 cm H2O ± 26.12 standard deviation (SD) to 21.07 cm H2O ± 17.32 SD (P < 0.001, n = 34). Maximum bladder pressure (MBC) increased by 34% from 260.45 ml ± 200.26 SD to 348.45 ml ± 175.90 SD. Positive or similar effects compared to previous therapies were seen in bladder morphology, number of incontinence episodes, urinary tract infections and adverse drug effects. This case series demonstrates that intravesical oxybutynin is an important addition to current therapies for the treatment of NDO and it is also efficacious in the rare setting of other underlying diseases beyond spinal cord injury or spina bifida. The approved intravesical oxybutynin preparation VESOXX® may be a useful alternative for patients who do not respond to other therapies or suffered side effects.

What is the success of drug treatment in urge urinary incontinence? What should be measured?

PURPOSE: The aim of this study is to evaluate the efficacy and the tolerability of three classic antimuscarinic drugs used in the treatment of over active bladder syndrome using clinical data and quality of life tests, and to evaluate the parameters affecting the success of these drugs. METHODS: A total of 90 patients with urge urinary incontinence were randomly allocated into three groups either to receive tolterodine (group A), trospium chloride (group B) or oxybutynin (group C). Urogenital distress inventory short form (UDI-6) and Incontinence impact questionnaire short form (IIQ-7) of the Turkish Urogynecology and Pelvic Reconstructive Surgery Association were performed to each patient before and after treatment to evaluate the effectiveness and tolerability of the antimuscarinic drugs. Adverse events were also recorded during treatment. RESULTS: Improved urodynamic test values were recorded after 6 weeks of treatment in each group. Similarly, statistically significant differences were observed in UDI-6 and IIQ-7 test scores before and after treatment. Complete cure was achieved in 86 % of patients in group A; however, complete cure rates were 67 and 80 % in group B and C, respectively. Although, patients reported comparable tolerability against trospium chloride (77 %) and tolterodine (80 %), only 23 % of patients using oxybutynin considered the drug as tolerable. The most common side effect was dry mouth, followed by insomnia. Both dry mouth and insomnia was highest in group C (50 %). One patient (0.3 %) in group B and two patients (0.7 %) in group C reported that they did not want to continue to use the drug. CONCLUSION: Antimuscarinic medications are very successful in the treatment of urge urinary incontinence; however, the success of treatment is not only limited to clinical improvement. Patients do not regard a drug as successful unless it is tolerable, easy to adapt to the daily life and improve the quality of life even it has very successful clinical outcomes.

Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study.

BACKGROUND: Neurogenic detrusor overactivity (NDO) can damage the upper urinary tract leading to chronic renal impairment. Antimuscarinic therapy is used to improve urinary incontinence and protect the upper urinary tract in patients with NDO. OBJECTIVE: This study investigated safety and efficacy of fesoterodine, a muscarinic receptor antagonist, in 6‒<18-year-old patients with NDO (NCT01557244). STUDY DESIGN: This open-label phase 3 study included 2 pediatric cohorts. Patients in Cohort 1 (bodyweight >25 kg) were randomized to fesoterodine 4 or 8 mg extended-release tablets or oxybutynin XL tablets administered over the 12-week active comparator-controlled phase. The safety extension phase evaluated fesoterodine 4 and 8 mg for a further 12 weeks, with patients in the oxybutynin arm allocated to fesoterodine 4 or 8 mg. Patients in Cohort 2 (bodyweight ≤25 kg) were randomized to fesoterodine 2 or 4 mg extended-release beads-in-capsule (BIC) administered over a 12-week efficacy phase and 12-week safety extension phase. Patients with stable neurologic disease and clinically or urodynamically proven NDO were included. The primary endpoint was change from baseline to Week 12 in maximum cystometric bladder capacity (MCC). Secondary efficacy endpoints included detrusor pressure at maximum bladder capacity, bladder volume at first involuntary detrusor contraction, bladder compliance, and incontinence episodes. Safety endpoints included adverse event incidence, and specific assessments of cognition, behavior and vision. The pharmacokinetics of 5-hydroxymethyl tolterodine (5-HMT; fesoterodine's active metabolite) was determined using population-pharmacokinetic analysis. RESULTS: In Cohort 1 (n = 124), fesoterodine 4 and 8 mg treatment resulted in significant increases from baseline in the primary endpoint of MCC at Week 12. In Cohort 2 (n = 57), fesoterodine 2 and 4 mg BIC treatment resulted in improvements in MCC from baseline. Fesoterodine 4 and 8 mg and fesoterodine 4 mg BIC led to improvements in some secondary efficacy endpoints. The most common treatment-related adverse reactions were gastrointestinal effects, such as dry mouth, which occurred more frequently with oxybutynin than fesoterodine. No detrimental effects on visual accommodation or acuity, or on cognitive function or behavior were observed. DISCUSSION: These safety and efficacy results are consistent with limited published data on fesoterodine treatment in pediatric populations with overactive bladder or NDO. Study limitations include the lack of placebo control and the small sample size, which limits the ability to make formal efficacy comparisons and detect rare adverse reactions. CONCLUSION: Fesoterodine has a favorable benefit-risk profile in 6‒<18-year-old patients with NDO and may represent an additional option for pediatric NDO treatment.

An overview on mixed action drugs for the treatment of overactive bladder and detrusor overactivity.

OBJECTIVES: To provide an overview on the efficacy, tolerability, safety and health-related quality of life (HRQoL) of drugs with a mixed action used in the treatment of overactive bladder (OAB). EVIDENCE ACQUISITION: MEDLINE database and abstract books of the major conferences were searched for relevant publications from 1966 to 2011 and using the key words 'overactive bladder', 'detrusor overactivity', 'oxybutynin', 'propiverine', and 'flavoxate'. Two independent reviewers considered publications for inclusion and extracted relevant data, without performing a meta-analysis. EVIDENCE SYNTHESIS: Old and conflicting data do not support the use of flavoxate, while both propiverine and oxybutynin were found to be more effective than placebo in the treatment of OAB. Propiverine was at least as effective as oxybutynin but with a better tolerability profile even in the pediatric setting. Overall, no serious adverse event for any product was statistically significant compared to placebo. Improvements were seen in HRQoL with treatment by the oxybutynin transdermal delivery system and propiverine extended release. CONCLUSIONS: While there is no evidence to suggest the use of flavoxate in the treatment of OAB, both oxybutynin and propiverine appear efficacious and safe. Propiverine shows a better tolerability profile than oxybutynin. Both drugs improve HRQoL of patients affected by OAB. Profiles of each drug and dosage differ and should be considered in making treatment choices.

An alternative to treat palmar hyperhidrosis: use of oxybutynin.

PURPOSE: To evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating palmar hyperhidrosis in a large series of patients. METHODS: From January 2007 to June 2009, 180 consecutive patients with palmar hyperhidrosis were treated with oxybutynin. Data were collected from 139 patients (41 patients were lost to follow-up). During the first week, patients received 2.5 mg of oxybutynin once per day; from the 8th to the 42nd day, 2.5 mg twice per day; and from the 43rd day to the end of the 12th week, 5 mg, twice per day. All of the patients underwent three evaluations before and after the oxybutynin treatment (at 6 and 12 weeks), using a clinical questionnaire and a clinical protocol for quality of life (QOL). RESULTS: More than 80% of the patients experienced an improvement in palmar hyperhidrosis. Most of the patients showed improvements in their QOL (74.6%). The side effects were minor, with dry mouth being the most frequent (70.5%). CONCLUSION: The use of oxybutynin is an alternative as the first step in the treatment of palmar hyperhidrosis, given that it presents good results and improves QOL.

The cost-effectiveness of solifenacin vs fesoterodine, oxybutynin immediate-release, propiverine, tolterodine extended-release and tolterodine immediate-release in the treatment of patients with overactive bladder in the UK National Health Service.

OBJECTIVE: To assess the cost-effectiveness of solifenacin vs other antimuscarinic strategies commonly used in UK clinical practice, based on the results of a recent published review. METHODS: Overactive bladder (OAB) syndrome is characterized by symptoms of urgency, frequency, incontinence and nocturia. Pharmacological treatment comprises oral antimuscarinic agents, which are divided into older-generation treatments, including oxybutynin, and new-generation treatments, comprising solifenacin, tolterodine, darifenacin and fesoterodine. The latter have reduced central nervous system penetration and have better selectivity for the M3 subclass of acetylcholine receptors, resulting in improved tolerability. A recent systematic review and meta-analysis of the efficacy and safety of antimuscarinics provided an opportunity for an economic evaluation of these agents using a rigorous assessment of efficacy. A cost-utility analysis was undertaken using a 1-year decision-tree model. Treatment success was defined separately for urgency, frequency and incontinence, with efficacy data taken from the recent review. Treatment persistence rates were taken from the Information Management System database. Utility values for the calculation of quality-adjusted life-years (QALYs) were taken from published sources. The analysis included costs directly associated with treatment for OAB, i.e. antimuscarinic therapy, consultations with general practitioners, and outpatient contacts. Resource use was based on expert opinion. Costs were reported at 2007/2008 prices. Extensive deterministic and probabilistic analyses were conducted to test the robustness of the base-case results. RESULTS: Solifenacin was associated with the highest QALY gains (per 1000 patients) for all three outcomes of interest, i.e. urgency (712.3), frequency (723.1) and incontinence (695.0). Solifenacin was dominant relative to fesoterodine, tolterodine extended-release (ER) and tolterodine immediate-release (IR), and cost-effective relative to propiverine ER for urgency, frequency and incontinence. Solifenacin was not found to be cost-effective relative to oxybutynin IR for the frequency and incontinence outcomes, with an incremental cost-effectiveness ratio of > pound30,000/QALY threshold. CONCLUSIONS: Solifenacin provided the greatest clinical benefit and associated QALYs for all three outcomes of interest across all therapies considered, and to be either dominant or cost-effective relative to all other new-generation agents, but not cost-effective relative to oxybutynin for frequency and incontinence.

Pediatric voiding dysfunction: a case study.

A 14-year-old male was evaluated and treated for frequent urination associated with straining to void, a sensation of incomplete emptying, and nocturia. Treatment and outcomes are presented in this article.

Therapeutic options in childhood nocturnal enuresis.

Monosymptomatic nocturnal enuresis, a heterogeneous condition, is frequently treated in children aged >5 years. Of the various treatment options, enuresis alarm has been widely advocated as being effective for treating nocturnal enuresis, while extracorporeal pelvic floor magnetic stimulation for overactive bladder, urge incontinence and urgency-frequency syndrome has not yet been confirmed by controlled studies as primary treatment for monosymptomatic nocturnal enuresis. Desmopressin, an antidiuretic hormone (ADH) analog, or arginine vasopressin (AVP), can resolve primary nocturnal enuresis by decreasing night-time urine production. Enuretic children requiring either desmopressin or desmopressin plus oxybutynin to achieve dryness have polyuria. Tricyclic antidepressants (i.e. imipramine) are used successfully in enuretic children. Although tricyclics and desmopressin are effective in reducing the number of wet nights, most children relapse after discontinuation of active treatment. Combined therapy (enuresis alarm, bladder training, motivational therapy and pelvic floor muscle training) is more effective than each component alone or than pharmacotherapy. Furthermore, desmopressin combined with alarm therapy has a positive effect on enuresis. Pharmacotherapy can provide early relief of enuresis, while behavioral intervention may lead to greater long-term benefits. The positive effect of achieving dry nights with pharmacotherapy can encourage the child to sustain behavioral therapy.

Oxybutynin: dry days for patients with hyperhidrosis.

We report the case of a 56-year-old postmenopausal woman who was referred to our Endocrinology Outpatient Clinic because of severe hyperhidrosis. She had a four-year history of excessive sweating of her face and upper body. On presentation no sweating could be documented. Physical examination was also unremarkable. It appeared that five days earlier her general practitioner had prescribed oxybutynin for urge incontinence and this accidentally cured her hyperhidrosis. She was diagnosed with idiopathic hyperhidrosis. We advised her to continue the oxybutynin and six months later, she was still symptom-free. Oral anticholinergic drugs are known to be effective for hyperhidrosis, but only anecdotal reports on oxybutynin can be found in the literature. Oxybutynin is not approved for hyperhidrosis, explaining the unfamiliarity with this medicine. This case shows that oxybutynin can be a very effective and simple treatment with only mild side effects. Therefore, oxybutynin merits consideration in patients with idiopathic hyperhidrosis. This report includes a concise review of the causes and treatment options of hyperhidrosis.

[Diagnosis and treatment of urinary bladder dysfunctions in patients with nephrotuberculosis].

A combined, including urodynamic, study was made in 129 patients with abnormal reservoir function of the urinary bladder (UB). Of them, 82 patients had nephrotuberculosis (NT). Cystoscopy was made in 93 patients, endovesical multifocal biopsy of the bladder wall-- in 23. Correction was conducted with alpha-adrenoblocker alfusozine. In NT, sensory functional disorders of UB prevail (60%). The degree of fibrous-inflammatory involvement of the bladder wall by biopsy findings and severity of urodynamic disorders do not correlate (r < 0.03). Miction recovered in 81.5% patients with NT taking alfusozine. Ileocystoplasty (n = 20) was made in treatment failure and total UB fibrosis. Long-term pathogenic action of specific infection on the neuroreceptor system of the UB may cause defects in its activity. Complex urodynamic investigations of the lower urinary tracts in NT patients identify the type of the disorder and help in making choice of pharmacological or surgical correction. Alfusoxine is a drug of choice in UB hypersensitivity.

Overactive bladder: evaluation and management in primary care.

Primary care physicians must initiate a discussion of overactive bladder and urinary incontinence with their patients who are at risk. A stepwise approach to evaluation and diagnosis and the use of systematic evaluation and treatment algorithms suitable to the primary care setting will improve identification and effective management of the incontinent patient.

Management of overactive bladder in a difficult-to-treat patient with a transdermal formulation of oxybutynin.

Antimuscarinic agents, effective in relieving symptoms of overactive bladder, are associated with anticholinergic-mediated adverse events, particularly at high dosages. The outcome of a difficult-to-treat patient requiring high doses of anticholinergic therapy who was successfully treated with transdermal oxybutynin after failing oral therapies is reported.

Perceived efficacy of cyclandelate in the treatment of cochleovestibular and retinal disturbances related to cerebrovascular insufficiency. A study in general practice comprising 2772 patients.

To investigate the perceived efficacy and safety of cyclandelate when used in general practice, an open multicentre study was performed comprising 2772 patients with symptoms of vertigo, tinnitus or visual disturbances thought to result from cerebrovascular insufficiency. After 90 days' treatment with cyclandelate 1600 mg daily in 2 doses, both the severity and frequency of these symptoms declined. The general practitioners rated the overall therapeutic efficacy of cyclandelate as 'excellent' or 'good' in 81% of patients, while 77% of patients considered the efficacy of the drug to be 'excellent' or 'good'. Side effects were infrequent and of a mild nature. Thus, when used in the setting of general practice, cyclandelate seems to be a safe and apparently effective treatment for patients with symptoms of vertigo, tinnitus and visual disturbances attributable to chronic cerebrovascular insufficiency.

Cyclandelate in the treatment of multi-infarct dementia. Interim findings from a multicentre study in general practice.

An open, multicentre clinical trial conducted in general practice was undertaken to investigate the effects of treatment with cyclandelate 800 mg twice daily in elderly patients with multi-infarct dementia. Interim findings in 303 patients demonstrate significant improvements after 12 weeks' treatment in mean scores of cognitive functions, orientation, verbal communications, social behaviour and interest in others and in the environment as assessed by the Blessed Dementia Scale and Parkside Behavioural Scale. Although a placebo response cannot be excluded because of the uncontrolled design of the study, these findings appear to warrant further investigation in well-designed controlled clinical trials in patients with multi-infarct dementia.

Treatment-emergent incontinence with lithium.

Four (17%) of 23 consecutive female outpatients developed significant urinary or urgency incontinence when treated with lithium carbonate. The symptoms remitted or abated with the addition of oxybutynin (an anticholinergic drug), imipramine, or with decreased lithium dosing. A proposed mechanism involves lithium-induced changes in bladder cholinergic-adrenergic balance.