Durable improvements in urinary incontinence and positive treatment response in patients with idiopathic overactive bladder syndrome following long-term onabotulinumtoxinA treatment: Final results of 3.5-year study.

Objectives: Here we present the final results from an extension study assessing long-term onabotulinumtoxinA treatment (3.5 years) in patients with idiopathic overactive bladder.

Methods: Patients who completed either of 2 Phase III trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 U) treatments.

Oxybutynin: past, present, and future.

Oxybutynin chloride is primarily indicated for the treatment of overactive bladder syndrome (OAB). It remains the most widely prescribed compound for OAB in the world. OAB is defined as the presence of urinary urgency, usually accompanied by daytime urinary frequency and nocturia, with or without urgency urinary incontinence, in the absence of infection or other identifiable etiology.

Transforming growth factor beta1 gene expression during vaginal wound healing in a rabbit menopause model.

Objective: Surgical outcome following reconstructive pelvic surgery is largely dependent on the vaginal wound healing process. As peri- and post-menopausal women are the most likely candidates to undergo these surgeries, it is important to understand the effect of estrogen deficiency on this process. Transforming growth factor beta (TGFβ) is an important mediator of wound healing.

Measuring the success of combined intravesical dimethyl sulfoxide and triamcinolone for treatment of bladder pain syndrome/interstitial cystitis.

Introduction And Hypothesis: The purpose of this study was to investigate change in bladder capacity as a measure of response to combined intravesical dimethyl sulfoxide (DMSO) and triamcinolone instillations for the treatment of newly diagnosed bladder pain syndrome/interstitial cystitis (BPS/IC).

Methods: 141 newly diagnosed women were identified retrospectively. 79 were treated with weekly DMSO/triamcinolone instillations.

Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome.

Objective: This subgroup analysis of a phase-3 study evaluated the efficacy and safety of oxybutynin chloride topical gel (OTG) in women with overactive bladder syndrome (OAB).

Study Design: Women (n = 704) with urgency-predominant urinary incontinence received OTG or placebo for 12 weeks. The primary endpoint was change from baseline to last observation in number of daily incontinence episodes.

Foreign-body granuloma after injection of calcium hydroxylapatite for type III stress urinary incontinence.

Background: Foreign-body granuloma is a potential complication of periurethral injection of calcium hydroxylapatite for the treatment of type III stress urinary incontinence.

Cases: We present two cases of foreign-body granuloma formation after periurethral injection of calcium hydroxylapatite for type III stress urinary incontinence. Excision of the lesion resulted in cessation of pain in a symptomatic patient; however, it led to the resumption of stress urinary incontinence in both cases.

Two unusual presentations of bladder diverticula.

Background: Bladder diverticula are protrusions of the mucosal and submucosal layers of the bladder through the muscular wall of the bladder. We discuss the identification and management of two unusual presentations of bladder diverticula.

Case: In two cases of bladder diverticula, one presented as pelvic organ prolapse and the other largely replaced the anterior cervix and was incidentally encountered during a loop electrosurgical excision procedure.

Pharmacokinetics of oxybutynin chloride topical gel: effects of application site, baths, sunscreen and person-to-person transference.

Background: Oxybutynin chloride topical gel (OTG; Gelnique®) is an approved formulation for the transdermal administration of oxybutynin, an established antimuscarinic therapy for overactive bladder (OAB). Transdermal administration of oxybutynin minimizes plasma concentrations of the active metabolite N-desethyloxybutynin (N-DEO), which can have anticholinergic adverse effects.

Objectives: In four phase I studies, we separately assessed the effects of OTG application site selection on oxybutynin bioavailability (site-to-site study); the effects of post-application showering on oxybutynin steady-state pharmacokinetics (showering study); the effects of sunscreen application on oxybutynin absorption (sunscreen study); and the person-to-person transfer of oxybutynin through skin-to-skin contact at the application site (transference study).

Extrasphincteric perianal fistulae after sacrospinous fixation for apical prolapse.

Background: Delayed extrasphincteric perianal fistulae may be encountered after sacrospinous vaginal vault suspension or hysteropexy with permanent sutures.

Cases: We report two cases of extrasphincteric perianal fistulae: one after a sacrospinous vaginal vault suspension and one after a sacropsinous hysteropexy. Reproduction of the vaginal dissection performed to place the sacrospinous fixation sutures failed to expose the sutures, and the fistulae persisted.

The evolution of transdermal therapy for overactive bladder.

Oxybutynin chloride has been effectively used for treating overactive bladder syndrome for more than three decades. The evolution of different delivery systems led first to intravesical administration, anal suppositories, and then to the commercial development of an extended-release oral formulation of oxybutynin chloride to improve its tolerability while maintaining efficacy. These modes of delivery were associated with decreased antimuscarinic side effects and N-desethyloxybutynin serum levels by avoiding first-pass metabolism in the upper gut and liver.

Efficacy and tolerability of fesoterodine in women with overactive bladder.

Introduction And Hypothesis: We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB).

Methods: This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12.

Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin.

Introduction And Hypothesis: In overactive bladder (OAB), subjects' most bothersome symptom (MBS) may influence treatment-related outcomes. We evaluated effects of solifenacin on patient-reported outcomes (PROs) in subjects stratified by their MBS at baseline.

Methods: In a 12-week, open-label study, the effects of solifenacin on PROs were assessed using visual analog scales (VAS), the OAB questionnaire (OAB-q), and the patient perception of bladder condition (PPBC).

Subjective measures of efficacy and quality of life in overactive bladder syndrome.

In recent years, more attention has turned to the use of patient-reported outcomes in clinical trials to assess treatment efficacy in overactive bladder syndrome (OAB). The challenge for investigators and clinicians is how to choose among the many available health-related quality-of-life questionnaires. This article provides an overview of the patient-reported outcome instruments available specific to OAB and their validation for clinical use.

Association between response to pentosan polysulfate sodium therapy for interstitial cystitis and patient questionnaire-based treatment satisfaction.

Objective: To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium (PPS) therapy in subjects with interstitial cystitis (IC).

Methods: A secondary analysis was conducted in 128 subjects treated with PPS 300 mg/day (US Food and Drug Administration-approved dose) from a 32-week multicenter, randomized, double-blind study of 380 subjects with IC who were treated with PPS 300 mg/day, 600 mg/day, or 900 mg/day. Self-rated outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a treatment satisfaction questionnaire.

Patient perspectives in the management of overactive bladder, focus on transdermal oxybutynin.

Overactive bladder syndrome (OAB) is a constellation of distressing symptoms that significantly impair quality of life, sexual function, and work productivity, and imposes a significant economic burden to society. Pharmacological treatment with antimuscarinic agents, behavioral modification, bladder retraining, and/or pelvic floor exercises are often used alone or in combination as the mainstay treatment in the management of OAB. Oxybutynin has been used in the treatment of OAB for over 20 years with proven efficacy and is often the comparator in drug treatment trials.

Overactive bladder syndrome presentations at the 31st International Urogynecological Association Annual Meeting.

There were 586 abstracts presented at the 31st Annual Meeting of the International Urogynecological Association in Athens, Greece, in September 2006. Many of these abstracts focused on the common condition of overactive bladder syndrome. The results of large multicenter industry-sponsored trials such as MATRIX, STAR, and SUNRISE were presented.

Evaluation and treatment of female urinary incontinence.

Urinary incontinence is a very common and bothersome condition among women and can affect up to 50% of women during their lifetime. Older women are disproportionately affected and often view urinary incontinence as a normal part of aging, thus precluding contact with medical professionals. Physicians must therefore include questions regarding urinary incontinence as part of routing examinations.

Evaluation and treatment of female urinary incontinence.

Urinary incontinence is a very common and bothersome condition among women and can affect up to 50% of women during their lifetime. Older women are disproportionately affected and often view urinary incontinence as a normal part of aging thus precluding contact with medical professionals. Physicians must, therefore, include questions regarding urinary incontinence as part of routine examinations.

The Colpexin Sphere: a new conservative management option for pelvic organ prolapse.

Pelvic organ prolapse is a frequently overlooked condition occurring commonly among women of all ages. A brief overview of pelvic organ prolapse and a discussion of the Colpexin Sphere is provided. The Colpexin Sphere is a new intravaginal device that facilitates the performance of pelvic floor muscle exercises thereby enhancing the benefit provided by already established conservative therapy.

Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study.

Objective: To assess health-related quality-of-life (HRQoL) and safety with the oxybutynin transdermal system (OXY-TDS) (Oxytrol), Watson Pharma, Corona, CA, USA) in the Multicentre Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (MATRIX) study, as HRQoL measurements are increasingly important in evaluating pharmacotherapy for overactive bladder (OAB).

Patients And Methods: This randomized, open-label, community-based study enrolled 2878 participants aged >/=18 years who had been given a diagnosis of OAB. The 327 study sites were representative of various practice types.

Detrusor overactivity and urge urinary incontinence following trans obturator versus midurethral slings.

Aims: To compare the rates of resolution of detrusor overactivity (DO) and subjective urge urinary incontinence (UUI) as well as de novo DO and UUI between the Monarc, TVT, and SPARC midurethral sling procedures.

Methods: Two hundred and seventy-six subjects with urodynamic stress or mixed urinary incontinence underwent retropubic midurethral slings (TVT, N = 99; SPARC, N = 52) or transobturator slings (Monarc, N = 125). All evaluable subjects had a routine office evaluation, subjective assessment of UUI, and multichannel urodynamic testing pre- and 3 months postoperatively.

The impact of the overactive bladder syndrome on sexual function: a preliminary report from the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin trial.

Objective: The objective of the study was to determine the impact of overactive bladder on sexual function from a preliminary analysis of the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study.

Study Design: The Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study was an open-label, prospective trial of 2878 subjects with overactive bladder, treated with transdermal oxybutynin for 6 months or less. The impact of overactive bladder on sexual function before and after treatment was assessed via item responses from the King's Health Questionnaire and Beck Depression Inventory-II (kappa-test).

Is transobturator tape as effective as tension-free vaginal tape in patients with borderline maximum urethral closure pressure?

Introduction: The purpose of this study was to compare transobturator tape (MONARC) with tension-free vaginal tape in patients with borderline low maximum urethral closure pressure.

Study Design: Historical cohort analysis of 3-month outcomes in 145 subjects (MONARC = 85; tension-free vaginal tape = 60). A cut-off point of 42 cm H2O for preoperative maximum urethral closure pressure was identified as predictor of success in the entire cohort.

Biomechanical characterization of vaginal versus abdominal surgical wound healing in the rabbit.

Objective: The objective of the study was to compare biomechanical properties of vaginal versus abdominal surgical wound healing in the rabbit.

Study Design: Bilateral 6-mm full-thickness circular segments were excised from the vagina and abdominal skin in 38 New Zealand White female rabbits. Animals were killed 0, 4, 7, 10, 14, 21, 28, and 35 days after wounding, and the wounds were assessed for surface area and tensile properties.

Effect of parity on sexual function: an identical twin study.

Objective: To assess the impact of childbirth on female sexual function by using an identical twin study design.

Methods: A survey including the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) was administered to 542 twin sisters, and PISQ-12 scores of 29 twin pairs discordant for parity were compared. Multiple linear regression models were used to evaluate impact on total PISQ-12 scores in 276 identical, sexually active twins.