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Biomedical subjects

Roger R Dmochowski

Publications and source records attributed to Roger R Dmochowski.

At least 37 records · Page 2Linked to original sources
PubMed2005

Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles: a subanalysis of data from the OPERA trial.

OBJECTIVE: This study was undertaken to compare the central nervous system (CNS) tolerability profiles of the extended-release formulations of oxybutynin chloride and tolterodine tartrate in the treatment of women with overactive bladder (OAB), as observed in the OPERA (Overactive bladder: Performance of Extended Release Agents) trial. STUDY DESIGN: The OPERA trial was a randomized, double-blind, active-control comparison of the efficacy and safety of extended-release oxybutynin (10 mg/d) and extended-release tolterodine (4 mg/d) given to 790 women with OAB for 12 weeks. The incidence of reported CNS events was compared between the treatment groups by using the Fisher exact test. RESULTS: The incidence of CNS adverse events was 9% and 8% for the oxybutynin and tolterodine treatment groups, respectively. The difference between groups was not statistically significant. All reported CNS adverse events were rated as mild or moderate in severity. There were no serious treatment-related adverse events in either group, and discontinuation because of a CNS adverse event was infrequent. CONCLUSION: The extended-release formulations of oxybutynin and tolterodine were observed to be associated with a similar low incidence of CNS adverse events, which were mostly mild or moderate in severity.

Benzhydryl Compounds↗
PubMed2005

Office urodynamics.

Explore the source record for details and available documents.

Equipment Design↗
PubMed2005

Urinary incontinence: proper assessment and available treatment options.

Urinary incontinence is a common condition that imposes significant burdens on the health and well-being of the patient. Urinary incontinence is underreported because people who suffer from the disorder are often reluctant to discuss it with healthcare professionals. It is undertreated because of misperceptions regarding its etiology and amenability to therapy. Failure to distinguish among the different types of urinary incontinence can hinder optimal treatment. This summary paper reviews the types of urinary incontinence, its prevalence, its impact on medical costs and patient quality of life, and approaches to diagnosis and treatment.

Female↗
PubMed2005

Efficacy and safety of extended release oxybutynin for the treatment of urge incontinence: an analysis of data from 3 flexible dosing studies.

PURPOSE: We assessed the efficacy and safety of extended release (ER) oxybutynin at individualized doses for urge urinary incontinence. MATERIALS AND METHODS: Data were combined from 3 flexible dosing studies of a total of 420 patients with urge urinary incontinence or mixed incontinence in whom ER oxybutynin dose adjustments were made to achieve the optimal balance between efficacy and tolerability, as judged by each participant. Individual doses were adjusted in 5 mg increments across a dose range of 5 to 30 mg daily. Efficacy was assessed during maintenance therapy using a 7-day diary. RESULTS: Data on 368 patients who completed dose adjustment were included in the analysis. In 47% of patients the preferred dose was greater than 10 mg daily. Individualized doses of ER oxybutynin produced a 79.3% decrease from baseline in the total of all incontinence episodes and an 83.2% decrease in urge episodes. Of patients 81% achieved a decrease of at least 70% in all incontinence episodes and 43% achieved total dryness. Moderate or severe dry mouth was reported by 23% of patients and it was cited as the cause for early withdrawal by 1.4% who completed dose adjustment. Therapy was well tolerated. In the pooled sample overall 6.7% of patients cited adverse events as the reason for discontinuing. CONCLUSIONS: Individualized dosing with ER oxybutynin was associated with highly effective and well tolerated control of urinary incontinence with more than 40% of patients achieving total dryness.

Adult↗
PubMed2005

Bladder-health diaries: an assessment of 3-day vs 7-day entries.

OBJECTIVES: To assess the reliability of symptom reports in 3-day vs 7-day bladder diaries used in clinical trials of patients with overactive bladder (OAB) and to compare those results and related issues with previous reports. MATERIALS AND METHODS: We analysed two large-scale, randomized, phase 3 clinical trials of the use of transdermal oxybutynin for treating patients with OAB. The first trial (Trial A, 520 patients) compared three doses of transdermal oxybutynin (1.3, 2.6 and 3.9 mg/day) with placebo. Patients documented their OAB symptoms in a 7-day diary. The second clinical study (Trial B, 361 patients) compared the efficacy of 3.9 mg/day transdermal oxybutynin with 4 mg/day extended-release tolterodine and with placebo; this trial required symptom recording for only 3 days. The internal consistency of the data from the 7-day trial was determined and then compared with the 3-day trial results. RESULTS: Patients on transdermal oxybutynin or long-acting tolterodine for their OAB symptoms showed a clinically and statistically significant improvement, results that were documented in both 3-day and 7-day bladder diaries. However, compared with 7-day symptom records, 3-day diaries were associated with significantly better compliance with record-keeping (P < 0.001). CONCLUSIONS: Seven-day diaries used in clinical trials supply accurate and reproducible data on clinical manifestations of OAB, but 3-day diaries are equally effective and have the potential for better accuracy through increased patient convenience. Three-day diaries may also reduce the tendency for patients to complete gaps in record-keeping from memory.

Benzhydryl Compounds↗
PubMed2005

Bladder neck pubovaginal slings.

Over the past 30 years, the pubovaginal sling has surpassed retropubic and transvaginal suspensions as the most common surgical operation for correcting stress urinary incontinence. This resurgence has been due in part to innovative technological advances that have shortened operative times and expedited postoperative recovery. The introduction of novel allografts, xenografts and synthetic materials has also been accompanied by unique complications, previously not encountered with autologous materials. The aim of this review is to compare the available sling materials in the context of biocompatibility and efficacy.

Biocompatible Materials↗
PubMed2005

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.

Algorithms↗
PubMed2005

Tegresstrade mark Urethral Implant Phase III Clinical Experience and Product Uniqueness.

Advances in materials technology, coupled with a heightened understanding of wound healing and tissue-materials interactions in the lower urinary tract, have led to the development of a variety of new urethral bulking agents that are expected to be available in the near future. Experience with such bulking agents continues to grow and study results are disseminated as more clinical trials are initiated and completed. The intention of this report is to review the characteristics and initial clinical results for one of these new agents: Tegresstrade mark Urethral Implant (C. R. Bard, Inc., Murray Hill, NJ). This material, with unique phase-change properties upon exposure to body temperature fluids, offers ease of injection and requires less volume for clinical effect than bovine collagen. Additionally, Tegress Urethral Implant performance in clinical trials has suggested improved durability and correspondingly higher continence and improvement rates versus bovine collagen. As these materials evolve, an understanding of preferential implant techniques is being gained also. Delivery method and implant site may prove to substantially alter the biologic activity of these compounds. As outlined in this review, experience with Tegress Implant resulted in changes in delivery technique that translated into improved materials and tissue interaction.

Journal Article↗
PubMed2005

Bladder outlet obstruction: etiology and evaluation.

Numerous gender-specific etiologies are responsible for bladder outlet obstruction (BOO). BOO may be induced by specific functional and anatomic causes. The resulting obstruction frequently produces lower urinary tract symptoms (LUTS). Categorizing and understanding these entities is crucial when proceeding with a LUTS evaluation as specific diagnostic modalities may then be used to fully delineate the degree of BOO and any secondary issues. Although urodynamic evaluation and pressure flow evaluation is the gold standard diagnostic tool, other modalities may also be used, including post void residual analysis, urinary flow rates, cystoscopy, and selected radiologic ones. Patient self-appraisal of symptoms using various inventories such as the American Urologic Association Symptom Index or the International Prostate Symptom Score is relevant to the initial assessment and subsequent longitudinal follow up. Analysis of secondary symptoms of obstruction in women is often performed using a subjective symptom appraisal and is determined urodynamically, assessing the pressure-flow relation during voiding. The complete assessment of LUTS arising from BOO often includes several of these modalities to fully define the obstructive impact on the individual's urinary function and quality of life.

Journal Article↗
PubMed2004

Sling failures: what's next?

The pubovaginal sling has been used to treat anatomic, functional, and recurrent stress urinary incontinence for decades with excellent results. Nevertheless, enthusiasm for the pubovaginal sling is tempered by the surgical morbidity and postoperative voiding dysfunction associated with it. New modifications such as alternative sling materials, bone anchor suspension, and midurethral slings have been developed to reduce operating time and surgical morbidity. The less invasive approaches are now well recognized and midurethral slings have become the most common procedure performed for stress urinary incontinence. Despite the ubiquity of sling procedures in all of their forms, there is no consensus on the management of sling failures. Recent literature suggests that similar to primary genuine stress incontinence, recurrent stress urinary incontinence as a result of sling failure is being successfully managed with less invasive techniques.

Algorithms↗
PubMed2004

Porcine dermis interposition graft for repair of high grade anterior compartment defects with or without concomitant pelvic organ prolapse procedures.

PURPOSE: Recent literature suggests that graft interposition may decrease the incidence of cystocele recurrence. We describe our experience with porcine dermis interposition grafts for the repair of high grade cystoceles. MATERIALS AND METHODS: We retrospectively reviewed the charts of all women who underwent surgical repair of high grade cystocele. Prolapse was graded with the Baden-Walker and Pelvic Organ Prolapse Quantitation systems, and all patients were evaluated with multichannel videourodynamics. Concomitant stress urinary incontinence was corrected with a pubovaginal sling and vault prolapse was corrected with iliococcygeus vault suspension. Postoperatively patients were evaluated at 2 weeks, 2 months, 6 months and annually thereafter. RESULTS: A total of 70 patients underwent cystocele repair with a porcine dermis interposition graft. Concomitant procedures included a pubovaginal sling in 65 patients and vaginal vault suspension in 50. Mean followup was 24 months. There were no intraoperative complications. Of the patient 59 (91%) are currently dry. One patient had recurrent vault prolapse without cystocele (C -2), which was successfully repaired with abdominal sacral colpopexy. Six patients (8.6%) experienced recurrent grade II (Ba 0) cystocele but continued to be asymptomatic. Three others (4.3%) had recurrence of grade III (Ba +2) cystocele and elected not to undergo reoperation. Two of 6 de novo rectoceles (grade II, Ap and -1 and Bp 0) were repaired with site specific repairs. Superficial vaginal wound separation in 1 case was successfully treated conservatively. CONCLUSIONS: In cases of high grade cystocele interposition of porcine dermis represents a successful and safe treatment option. Cystocele recurrence is typically low grade and it frequently may not require additional surgery.

Animals↗
PubMed2004

Effect of antacid on the pharmacokinetics of extended-release formulations of tolterodine and oxybutynin.

BACKGROUND: In general, extended-release (ER) formulations are designed to prolong the duration of efficacy and reduce the adverse effects of a drug. These formulations often contain the entire daily dose in a single tablet. Therefore, failure of the ER mechanism not only diminishes the desired benefits, but may temporarily expose the patient to drug concentrations higher than those released from a conventional tablet. In this study we determined whether pH has an effect on drug release from the ER formulations of oxybutynin (OROS technology) and tolterodine (membrane coated beads) in vitro and in vivo. STUDY DESIGN: In vitro studies were based on standardised dissolution experiments for each drug in media of different pH (artificial gastric fluid at pH 1.2, artificial intestinal fluid at pH 7.5, and water). In the two separate, identically designed in vivo studies, single doses of each drug were administered alone and with an antacid to male and female healthy volunteers aged 18-45 years. The randomised, crossover, open-label in vivo studies employed a validated assay to determine plasma concentrations of tolterodine and its metabolite 5-hydroxymethyl tolterodine (5-HM), or oxybutynin and its metabolite N-desethyloxybutynin. RESULTS: The in vitro study showed similar slow and steady drug release from ER-oxybutynin in each pH medium, with 64-71% released after 12 hours. Drug release from ER-tolterodine was steady and slow in artificial gastric fluid, with 72.5% of drug released after 12 hours. However, drug release was much faster in artificial intestinal fluid and water, where 69.8% and 69.1%, respectively, of the drug was released within 4 hours. These in vitro results were consistent with the findings of the in vivo studies. In vivo, the pharmacokinetic profile (peak plasma concentration [C(max)] and area under the concentration-time curve) of ER-oxybutynin was similar after administration with or without antacid, whereas C(max) values of both tolterodine and 5-HM increased significantly when ER-tolterodine was administered with antacid (p < or = 0.017 vs ER-tolterodine alone). CONCLUSIONS: Changes in pH affected the release of tolterodine from ER-tolterodine, while they had no effect on the release of oxybutynin from the proprietary ER technology used in ER-oxybutynin. The technology employed in ER formulations thus determines sensitivity of drug release to external factors.

Adolescent↗
PubMed2004

Duloxetine: a summary of published clinical experience.

Effective oral therapy for genuine stress urinary incontinence (SUI) in women has, to date, been an unattainable goal. Although oral pharmacologic agents have been used for this condition, none has ultimately been successful, because of side effects, lack of efficacy, or problematic compliance with drug ingestion. The availability of an effective oral agent for SUI would increase the range of therapeutic options for symptom management and possibly make treatment accessible to more women who otherwise feel that surgical therapy is not an option because of social, personal, or medical reasons. Duloxetine is a selective serotonin (5-HT) and norepinephrine reuptake inhibitor that has been shown to increase rhabdosphincter activity. Rhabdosphincter contractility changes are thought to occur as the result of increased stimulation of alpha(1)-adrenergic and 5-HT(2) receptors in the sacral spinal cord, resulting in increased efferent pudendal nerve activity, producing increased pelvic floor tonus. Two large-scale studies have been completed employing subjective and objective outcomes to assess the therapeutic index of duloxetine as a therapy for SUI.

Journal Article↗
PubMed2003

Muscarinic receptors: what we know.

An understanding of muscarinic receptors is tantamount to an understanding of overactive bladder. The M(3) muscarinic receptor subtype is responsible for detrusor smooth muscle contraction and it exerts an exocrine function in the salivary glands. Alterations in the receptor's response to acetylcholine as a result of injury may lead to hypersensitivity and overactivity. The M(2) receptor subtype, which is mainly responsible for cardiac function, is the muscarinic receptor of highest proportion in the detrusor. M(2) also may play a role in detrusor contraction in injury and pathologic states. Muscarinic antagonists are the mainstay of pharmacotherapy for overactive bladder, but those that are available are not tissue specific. Growing knowledge of the nuances of receptor-ligand behavior and interaction between muscarinic receptors subtypes may provide novel targets for future drug development, improve efficacy, and reduce bothersome side effects.

Animals↗
PubMed2003

Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence.

OBJECTIVES: To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence. METHODS: After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo. Evaluations included change from baseline in patient urinary diary symptoms, incontinence-specific quality of life, and safety. RESULTS: OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes (median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo; P <0.05), increased the average void volume (median change 24 and 29 mL versus 5.5 mL, P <0.01), and improved quality of life (incontinence impact questionnaire [IIQ] total score, P <0.05; Urogenital Distress Inventory Irritative Symptom subscale, P <0.05) compared with placebo. The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4.1%). Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment (dry mouth 7.3% versus 1.7% placebo, P <0.05). CONCLUSIONS: OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence. OXY-TDS improves systemic safety with regard to anticholinergic side effects. Local skin irritation occurs in some OXY-TDS patients.

Administration, Cutaneous↗