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Biomedical subjects

Jacques Corcos

Publications and source records attributed to Jacques Corcos.

At least 19 recordsLinked to original sources

Long-term treatment with darifenacin for overactive bladder: results of a 2-year, open-label extension study.

OBJECTIVE: To examine, in a 2-year, non-comparative, open-label extension study, the safety, tolerability and efficacy of darifenacin controlled-release (CR) 7.5/15 mg once daily in patients with overactive bladder (OAB) who completed two 12-week randomized, double-blind, placebo-controlled 'feeder' studies. PATIENTS AND METHODS: Patients entering the extension received darifenacin 7.5 mg once daily for 2 weeks, after which a voluntary increase in dose to 15 mg was permitted. Thereafter, patients could adjust the dose (either 7.5 or 15 mg). Safety and tolerability were assessed from adverse events (AEs) and discontinuations. Efficacy was determined using various endpoints. RESULTS: In all, 716 patients entered the extension (mean age 57.3 years; 85.1% women) and 475 (66.3%) completed it (1089.9 patient-years of exposure). Darifenacin was well tolerated with no significant safety concerns. The most commonly reported AEs were dry mouth and constipation (all-causality rates 23.3% and 20.9%, respectively), leading to discontinuation in 1.3% and 2.4% of patients, respectively. Constipation infrequently required intervention, and analysis of bowel-habit questionnaires revealed that the reporting of constipation was related to minor changes in bowel habit rather than true constipation. The efficacy of darifenacin was maintained, including significant improvements in the number of incontinence episodes/week (median change -84.4% at 2 years, P < 0.001 vs feeder-study baseline). After 2 years, > 40% of patients achieved a > or = 90% reduction in incontinence episodes/week. CONCLUSION: In the first published 2-year, open-label study of a CR antimuscarinic agent, darifenacin 7.5/15 mg once daily had a favourable safety, tolerability and efficacy profile during the long-term treatment of OAB. As such, darifenacin represents a valuable therapeutic option for OAB.

Adult↗

Severe soft tissue infection of the thigh after vaginal erosion of transobturator tape for stress urinary incontinence.

Since the beginning of use of synthetic midurethral slings, several complications, usually benign, have been reported. Recently, three consecutive cases of severe thigh infection secondary to transobturator insertion of a synthetic tape alarmed us. This is a case report about these three cases and a review of literature about complications of transobturator tapes.

Abscess↗

Effect of the potassium channel opener WAY-133537 on the overactive bladder of spinalized rats.

AIMS: To test the efficacy of WAY-133537 for the treatment of overactive bladder (OAB) in a chronic paraplegic rat model. MATERIALS AND METHODS: Forty-eight female Sprague-Dawley rats were used in this study. Six animals served as normal controls (without spinal cord transaction (ST)), while 42 rats underwent ST at the 10th thoracic vertebra. Two weeks after ST, cystometrogram (CMG) was performed in six randomly chosen animals to ensure the development of neurogenic detrusor overactivity. The remaining 36 rats were divided into three equal groups, 12 received the vehicle as "paraplegic controls," 12 received WAY-133537 0.3 mg/kg, and 12 received WAY-133537 3 mg/kg. Each "paraplegic control" and treatment group was further divided into two sub-groups (n = 6), with CMG at 3 and 4 weeks after ST, respectively. RESULTS: Two weeks after ST, all "vehicle control" rats developed detrusor overactivity with a mean frequency of 0.96 and 1.48 contractions/min and amplitude of 22.96 and 31.22 cm H(2)O with 1- and 2-week treatment, respectively. Neurogenic detrusor overactivity disappeared from 50% of rats that received WAY-133537 0.3 mg/kg for 1 week, and frequency decreased to 0.41 contractions/min. After 2 weeks of treatment, detrusor overactivity vanished from 67% of the animals with even further reduction in the frequency of detrusor overactivity (0.22 contractions/min, P < 0.01). In rats that received 3 mg/kg of the drug for 1 week, detrusor overactivity disappeared from only one animal with a non-significant decline in frequency. Fifty percent of rats given WAY-133537 at the dose of 3 mg/kg/day for 2 weeks manifested no detrusor overactivity. CONCLUSIONS: WAY-133537 shows efficacy in increasing bladder capacity and reducing the frequency of spontaneous bladder contractions after ST in rats without decreasing voiding pressure.

Animals↗

Translating overactive bladder questionnaires in 14 languages.

OBJECTIVES: Overactive bladder (OAB) affects millions of people worldwide. Identifying patients and measuring OAB's impact on symptom severity and patients' health-related quality-of-life is necessary to ensure proper treatment and facilitate communication among patients, clinicians, and caregivers. To accomplish this, the Overactive Bladder questionnaire (OAB-q) and its subsets instruments, the OAB-q Short-Form and the OAB-V8, were developed in U.S. English. To measure the impact of OAB cross-culturally, we performed the linguistic validation of these instruments in Danish, English (Canada), French (Canada and France), Italian (Switzerland), German (Switzerland), Korean, Norwegian, Polish, Portuguese (Brazil), Romanian, Swedish, and Turkish. The linguistic validation was conducted following a rigorous method to ensure conceptual equivalence between the original and its translations. METHODS: In each country, a specialist monitored the process, which included six steps: (1) two forward translations; (2) comparison and reconciliation of the translations; (3) back-translation; (4) comparison of the source and back-translation; (5) review by one urologist or gynecologist; and (6) a comprehension test using patients. RESULTS: The translation of symptom-related adjectives such as "uncomfortable," "sudden," "accidental," "uncontrollable" proved challenging. The subtle differences in the meaning of symptomatic items increased the difficulties to find equivalents. Issues regarding the appropriateness of certain concepts and idiomatic terms emerged during cognitive debriefing. The terms "urge," "desire," "urination," "commute," "drowsy," and "escape routes" were not retained literally and were replaced by colloquial expressions. CONCLUSIONS: The 14 versions of the OAB-q, OAB-q Short-Form, and OAB-V8 were successfully validated linguistically to facilitate data collection cross-culturally and the international comparison of symptom bother and health-related quality of life in patients with OAB.

Language↗

The relationship between sexual activity and urinary incontinence in older women.

OBJECTIVES: To determine whether continence status is associated with sexual activity in older women. DESIGN: Cross-sectional postal survey. SETTING: Random selection from a list of respondents to a Canada Post survey. PARTICIPANTS: Community-dwelling women aged 55 to 95. MEASUREMENTS: The International Consultation on Incontinence Questionnaire Short Form measured the presence, severity, and type of incontinence. Sexual activity and marital status were assessed using single close-ended questions. The Medical Outcomes Study 12-item Short-Form Health Survey was used to query physical and mental health status. RESULTS: Data from 2,361 women (mean age 71) were available for analysis. Thirty-nine percent reported urinary incontinence (UI), and 27% were sexually active. UI was associated with sexual activity in crude logistic analyses (odds ratio (OR)=0.82, 95% confidence interval (CI)=0.68-0.98) but not in multivariate models adjusted for physical and mental health. Marital status and age were the strongest predictors of sexual activity (OR 8.94, 95% CI=6.89-11.60 for married women; OR=3.09, 95% CI=2.57-3.73 for age <or=70), with significant relationships also observed with physical and mental health (OR=1.04, 95% CI=1.03-1.04 and OR=1.02, 95% CI=1.01-1.04, respectively). Frequency of UI was not related to being sexually active, although greater amounts of urine loss, stress incontinence, and nocturnal incontinence were independently associated with sexual activity (OR=0.53, 95% CI=0.33-0.85; OR=1.40 95% CI=1.01-1.94; and OR=0.24, 95% CI=0.10-0.61, respectively). CONCLUSION: Many older women remain sexually active as they age regardless of continence status. Caution should be exercised in interpreting intervention studies aimed at improving sexual function in incontinent older women if marital status and physical and mental health are not considered.

Aged↗

Improving the global management of the neurogenic bladder patient: part II. Future treatment strategies.

BACKGROUND: Patients with neurogenic bladder represent a small fraction of the total overactive bladder population. As a consequence, development of new therapies in this area has largely focused on idiopathic urinary incontinence. The absence of data for patients with neurological disease has far-reaching implications, affecting reimbursement and physicians' willingness to prescribe therapies, and limiting access of potential valuable treatments to patients whose lives are significantly impaired by inadequately managed bladder symptoms. SCOPE: The range of new therapies is increasing. Although many reviews of the overall safety, efficacy and mode of action of such treatments are available, there is limited information on how these treatments will best be used in clinical practice. We considered the current benefits and limitations of the various new licensed and unlicensed therapies and what role each would have in the future management of neurogenic urinary incontinence. CONCLUSIONS: A wide range of new treatments have been investigated for the management of overactive bladder; few, however, have been evaluated extensively in neurogenic urinary incontinence. Further studies are required to determine the optimal dosing regimes and formulations for individual sub-populations of neurogenic bladder patients and to determine the cost-effectiveness of these interventions. With the current experience available, two treatment algorithms for a subset of patients with neurological disease have also been proposed, which suggest at which stage of management and in which patients individual therapies for neurogenic urinary incontinence could be used.

Algorithms↗

Improving the global management of the neurogenic bladder patient: part I. The complexity of patients.

BACKGROUND: The management of urinary incontinence in patients with neurological disease is complex. Physicians face a multitude of challenges related to progression of the primary condition, the presence of a diversity of other related and unrelated symptoms, the safety, efficacy and tolerability issues associated with multiple therapies being required and the changing need for collaboration with other specialities. SCOPE: Current guidelines produced by the urological communities, as well as the disease-focused organizations, aim to standardize care in their specific group of patients. A passive approach to implementation, however, means that guidelines produced are all too frequently not readily available to, read by or followed by the wider audience. In addition, each speciality has its own guidelines and a different view of the primary focus of care in neurological patients, which may lead to variations in recommendations and, subsequently, in clinical practice. A review of current urological and disease specific guidelines was made to evaluate differences between the published guidance between the specialities and within urology itself. CONCLUSIONS: Although availability of effective therapies remains a cornerstone of neurogenic bladder treatment, consideration must also be given to the non-pharmacological and surgical issues related to the global management of this population. Improved cross-speciality interactions and development of patient-specific treatment and follow-up plans, which are in keeping with the current guidelines of each speciality involved, may serve to enhance physicians' understanding of the importance of effective urinary incontinence treatment as well as the overall management of the patient.

Europe↗

Injection of botulinum toxin type A in the urethral sphincter to treat lower urinary tract dysfunction: a review of indications, techniques and results.

The first application of botulinum toxin type A (BTA) in urology was its injection into the urinary sphincter to treat neurogenic detrusor-sphincter dyssynergia (DSD) in quadriplegic men. Since that first report in the eighties, the results of focal BTA injections into the sphincter, the bladder wall and lately into the prostate, have raised the interest of the urology community in this promising new therapeutic modality. An evidence-based review is presented of current indications, techniques and outcome of BTA injections into the urethral sphincter.

Administration, Topical↗

Canadian Urological Association guidelines on urinary incontinence.

OBJECTIVE: To develop the first Canadian guidelines for the management of adult urinary incontinence (UI). METHOD: Following a mandate of the Canadian Urological Association, six Canadian urologists collaborated to produce these guidelines after having extensively reviewed existing foreign guidelines and literature from 1966 to June 2005. RESULTS: The terminology proposed by the standardization committee of the International Continence Society (ICS) is recommended. Basic evaluation must include a history, physical examination, evaluation of post void residual volume, urinalysis and voiding diary. A more detailed evaluation is recommended for complex cases or if initial management fails. As non-pharmacological treatments, devices (catheters, pessaries, etc...) play an important role in selected patients. Lifestyle adjustments are recommended to be implemented first before considering other forms of treatment. Pelvic exercises can be helpful for the mildest cases of pelvic relaxation, in motivated compliant patients. In highly selected patients neuromodulation can improve the patient's quality of life. Probantheline, oxybutinin and tolterodine have a proven efficacy in the treatment of UI. Imipramine and oestrogens are suggested while flavoxate has an unproven efficacy. Surgery in women is indicated when the degree of incontinence is sufficiently troublesome to the patient, the incontinence has been observed by the examiner, its causes adequately evaluated and conservative therapies have been reviewed. Primary stress urinary incontinence in the female is effectively treated by a retropubic suspension (Burch or Marshall- Marchetti-Krantz), or a pubovaginal sling procedure. Pubovaginal slings are the procedure of choice in the presence of significant intrinsic sphincteric deficiency (ISD), the absence of hypermobility, or in the treatment following a failed retropubic suspension. Peri urethral injectables are recommended first line treatment of SUI when available. In men, artificial sphincter is the treatment of choice in neurogenic and non-neurogenic SUI. In neurogenic bladders and sometimes in non neurogenic bladders other forms of surgeries such as bladder denervation, bladder augmentations, neurostimulation, urinary diversion can be considered as the treatment of choice for individual patients. CONCLUSION: Canadian guidelines on incontinence have been completed in 2005 reflecting the Canadian health environment. This field of UI is in constant progression and, when of proven efficacy, new medications and devices have to be included in the proposed algorithm of care.

Exercise↗

[Urological applications of botulinum toxins].

Botulinum toxins (BT) are one of the most powerful poisons in nature. They are responsible for human botulism and constitute a potential chemical weapon, but can also be used as a therapeutic agent. Sphincter, bladder and prostatic injections have been described in urological indications as varied as detrusor-sphincter dyssynergia and neurogenic detrusor hyperactivity, idiopathic overactive bladder symptoms, interstitial cystitis, obstructive voiding disorders related to benign prostatic hyperplasia or chronic prostatitis, and recurrent urethral stricture. This review of the literature presents the results and level of evicence in support of the use of BT in urological indications. Detrusor injections of BT-A constitute an alternative conservative treatment that is effective in the short term (6-12 months) after failure of anticholinergic agents to treat neurogenic detrusor hyperactivity (level 1b). Sphincter injections are effective in the short-term treatment of neurogenic detrusor-sphincter dyssynergia (level 1c). The efficacy observed during preliminary clinical trials of detrusor injections of BT-A for idiopathic overactive bladder symptoms or interstitial cystitis (level 4) and prostatic injections for obstruction related to BPH (level 1c) justifies the major interest raised by this new therapeutic approach. However, these preliminary results must be confirmed by comparative studies on a sufficient number of patients with long-term follow-up before considering the use of this technique in routine clinical practice.

Botulinum Toxins↗

Prevalence and occurrence of stress urinary incontinence in elite women athletes.

OBJECTIVE: 1) To assess the prevalence of stress urinary incontinence (SUI) and urge urinary incontinence (UTI) in elite women athletes versus the general female population, and 2) to analyze the conditions of occurrence of urine loss in search of etiological clues in elite athletes. DECISION: An anonymous self-questionnaire was collected transversally from women aged 18 to 35 years. The exposed group was composed of elite female athletes; the non-exposed group was made up of women in the same age range accepting to answer the questionnaire. RESULTS: A total of 157 answers from elite athletes and 426 from control subjects were available for analysis. Urinary incontinence prevalence was 28% for athletes and 9.8% for control subjects (p = .001). There was no significant difference in the relative prevalence of SUI between the athletes and control subjects. Athletes reported urine loss more frequently during the second part of the training session (p < 0.0003), and the second part of competition (p < 0.05). Urinary incontinence prevalence was 9.87% in physically-active control subjects versus 9.84% in sedentary control subjects (NS). Even a small quantity of urine loss was felt to be embarrassing. Most incontinent women did not dare to speak of their condition to anybody. CONCLUSIONS: There is a very high prevalence of urinary incontinence in women athletes. Detailed studies of the patho-physiology of this problem are necessary to formulate preventive recommendations.

Adolescent↗

Urological surveillance and management of patients with neurogenic bladder: Results of a survey among practicing urologists in Canada.

OBJECTIVE: To determine current trends in management and surveillance of the neurogenic bladder population by Canadian urologists who routinely work with and provide care for these patients. METHODS: A questionnaire was mailed to members of the Canadian Urological Association. The assessment and follow-up of upper and lower urinary tract function in neurogenic bladder patients, their optimal frequency and management of related infections were the topics of inquiry. RESULTS: One hundred and five of 602 urologists responded, for a response rate of 18%. Twenty-three (22%) of the respondents did not treat neurogenic bladder patients. Four out of five urologists who treated these patients favored a yearly renal ultrasound for routine surveillance of the upper urinary tract and routinely performed urodynamic studies for evaluation of the lower tract. Only a relatively small percentage used videourodynamics. Clean intermittent catheterization (CIC) was preferred for the management of neurogenic bladder in patients with emptying difficulties. Asymptomatic urinary tract infection (UTI) was preferably not treated. Symptomatic UTI was treated with antibiotics for 7 to 10 days by about 75% of the responding urologists, while 23% of female patients and 9% of male patients were treated for less than 7 days. Although most of the urologists had access to established treatment modalities, like CIC education and bladder augmentation, only 30% made use of botulinum toxin injections. CONCLUSIONS: This study confirms that most urologists in Canada, working with neurogenic bladder patients, follow principles reported in the literature regarding the need for evaluation, surveillance, and management of the urinary tract. However, there is no consensus on the specific methods used for surveillance of the urinary system. The results emphasize the need for clear guidelines in this field of urology in Canada.

Adult↗

Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC).

OBJECTIVE: To determine the safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC) patients. MATERIALS AND METHODS: IC patients were instilled with 50 cc of test solution containing either placebo, 0.05 microM or 0.10 microM RTX in the bladder. Plasma concentration of RTX and its degradant resiniferonol 9-, 13-, 14-orthophenylacetate was measured. Immediate post-treatment blood sampling and cystoscopy were performed. Symptoms were evaluated before treatment, at 4- and at 12-week follow-ups, using VAS indicator for pain, voiding diary, and O'Leary's IC symptom/problem indices. RESULTS: Among 22 patients observed (ten in 0.10 microM RTX, eight in 0.05 microM RTX, and four in placebo groups), the most commonly reported adverse event was pain during instillation (80.0%, 87.5%, and 25.0%). No serious adverse events were reported. CONCLUSIONS: Use of intravesical RTX in IC patients is associated with important tolerability issues but safe at 0.10 microM and 0.05 microM.

Administration, Intravesical↗

Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results.

PURPOSE: Suprapubic Arch sling (SPARC) has been initially presented as being comparable to Tension-free Vaginal Tape (TVT) without published trials. To test the safety and efficacy of this new product, we designed a prospective, randomized clinical trial with a minimum follow-up of 1 year. MATERIALS AND METHODS: 84 women presenting with Stress Urinary Incontinence (SUI) were randomly assigned to SPARC or TVT as a minimally invasive mid-urethral sling procedure. All patients were re-evaluated at 1, 6, and 12 months. Symptom assessment, Incontinence Impact Questionnaire (IIQ), physical examination, Uro-Dynamic Studies (UDS) and 1-hour pad test were repeated at 1-year follow-up. RESULTS: 41 patients were randomized to SPARC and 43 to TVT. The two groups had similar baseline characteristics. Both procedures resulted in similar peri-operative complications: bladder perforation (24% vs. 23%), median estimated blood loss (0-50 ml), median hospital stay (1-night), post-operative analgesia, and persistent urinary retention necessitating tape resection (2 patients in each group). There were three other complications in the SPARC group: tape erosion, infected pelvic hematoma, and urinary tract infection. At 12 months, there was no statistically significant difference between SPARC and TVT, in terms of objective cure rates as determined by 1-hour pad test of less than two grams (83% vs. 95%; p< or =0.1; 12% difference, 95% CI: 25.4% to -1.4%) and subjective cure rates as determined by IIQ scores (49.9+/-25.6 vs. 45.3+/-18.4; p=0.46). CONCLUSIONS: At 1-year follow-up, there is no statistically significant difference between SPARC and TVT. Longer follow-up is needed to confirm these results.

Aged↗

Sacral neuromodulation: long-term experience of one center.

OBJECTIVES: To perform a retrospective analysis of the long-term results of our experience with neuromodulation. Our center has been involved in the early studies leading to approval of the NeuroStim system of neuromodulation for the treatment of patients presenting with refractory lower urinary symptoms of urgency/frequency with or without incontinence and chronic urinary retention. METHODS: A total of 52 patients have undergone implantation at our center since 1990 using very rigid criteria, including temporary percutaneous nerve evaluation for up to 7 days and a requirement of 50% improvement before consideration for implantation. Patients were followed up closely and a telephone questionnaire was conducted for those patients not seen in the previous 6 months. Of the 52 patients, 11 were not available for evaluation. Of the 41 remaining patients, 22 had urgency/frequency syndrome, 6 had urgency incontinence, 9 had urinary retention, and 4 had interstitial cystitis with intractable pelvic pain. RESULTS: Of the 41 patients, 5 required explantation. These 5 patients were offered reimplantation but declined. Of the 22 patients in the urgency/frequency group, 10 (45%) had persistent improvement. In the urgency incontinence group, 3 of the 6 patients required explantation, and 1 (17%) reported improvement in the frequency of incontinence episodes. Of the 9 patients in the chronic urinary retention group, 7 (78%) had improvement. CONCLUSIONS: The long-term (up to 13 years) results of neuromodulation in patients presenting with urgency/frequency with and without urge incontinence and urinary retention were reviewed. The long-term results in the first two groups were not maintained over time. The patients with chronic urinary retention, although a small sample, fared better.

Adolescent↗

Botulinum toxin injections for paediatric incontinence.

PURPOSE OF REVIEW: This review highlights a recent innovation in the medical treatment of children with neurogenic detrusor overactivity. Anticholinergics are usually the main way to treat bladder overactivity. Side effects and lack of efficacy are the two main causes for considering alternative treatment. Up to recently, invasive surgery, mainly bladder augmentation, was the only available treatment for these intractable bladders. Here, we report on botulinum A toxin injection as an alternative to surgery in children with neurogenic detrusor overactivity. RECENT FINDINGS: There are only four published articles on the use of botulinum A toxin in children with neurogenic detrusor overactivity. However, an increasing number of reports indicate clinical benefit and a good safety profile of botulinum A toxin in neurogenic and idiopathic detrusor overactivity. Extrapolation of the data published in adults treated with botulinum A toxin injections and understanding the mechanism of action on the detrusor muscle are worthwhile to encourage paediatric physicians to propose this option to their patients. Furthermore, the literature does not seem to warn against drug resistance or ultrastructural changes of the detrusor after repeated injection. SUMMARY: Botulinum A toxin appears to be a reasonable alternative to surgery in the management of intractable overactive bladder in children. However, studies of the delivery method, site of injection, dose and long-term follow-up are required to confirm the good safety profile/clinical benefit of this new, minimally invasive approach.

Animals↗