NEWS HIGHLIGHTS
Published Studies Related to Detrol (Tolterodine)
Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. [2009.09]
PURPOSE: The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated... CONCLUSIONS: This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.
Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence. [2009.09]
CONCLUSIONS: Tolterodine ER treatment was associated with improvements in multiple OAB- and incontinence-specific PROs in a sexually active, relatively young, and racially diverse population of women. The findings provide clinicians with new insights into the impact of OAB and its treatment on HRQL in this population, which has been underrepresented in previous OAB studies. Study limitations include a potential underestimation of the impact of OAB symptoms resulting from the exclusion of women who may not be sexually active because of their urinary symptoms.
[Combination of tolterodine and tamsulosin for benign prostatic hyperplasia] [2009.07]
OBJECTIVE: Overactive bladder may coexist with bladder outlet obstruction induced by benign prostatic hyperplasia (BPH). This study aimed to evaluate the efficacy of the combined use of tolterodine and tamsulosin in the treatment of BPH accompanied by overactive bladder... CONCLUSION: Tamsulosin could quickly relieve BPH-induced lower urinary tract symptoms (LUTS) , while the combined use of tolterodine and tamsulosin could even better alleviate the LUTS and improve the QOL of BPH patients.
Continued symptom improvement in sexually active women with overactive bladder and urgency urinary incontinence treated with tolterodine ER for 6 months. [2009.04]
Improvements in overactive bladder (OAB) symptoms and health-related quality of life (HRQL) were assessed during a 24-week study of tolterodine extended release (TOL ER) in sexually active women with OAB and urgency urinary incontinence (UUI). A 12-week, double-blind, randomized, placebo-controlled trial was followed by a 12-week open-label phase...
The pharmacokinetic profile of fesoterodine: similarities and differences to tolterodine. [2009.03.07]
BACKGROUND: Fesoterodine is a new antimuscarinic agent developed for the treatment of overactive bladder. Fesoterodine itself is inactive and is rapidly and extensively converted by ubiquitous esterases to its principal active moiety, 5-hydroxymethyl tolterodine (5-HMT). 5-HMT is formed via biotransformation of both fesoterodine and tolterodine, albeit by different metabolising enzymes, viz. esterases and CYP2D6 respectively. Tolterodine is a potent muscarinic receptor antagonist and has been used for the treatment of overactive bladder for over ten years. The objective of this study was to establish the pharmacokinetic profile of fesoterodine and to highlight ist potential pharmacokinetic advantages over tolterodine... CONCLUSIONS: Due to the esterase-mediated cytochrome P450-independent formation of 5-HMT and involvement of multiple metabolic and renal excretion pathways in the elimination of 5-HMT, the effects of patient-intrinsic and -extrinsic factors on the pharmacokinetics of fesoterodine are only modest, with some 2-fold higher 5-HMT exposure. Therefore, in contrast to tolterodine, no reduction of fesoterodine dosage is required under conditions of reduced elimination. In most cases of drug interaction or renal/hepatic impairment, the fesoterodine dose may be increased to 8 mg/day based on individual patients' response, or patients may be required to remain at the initial recommended dose of 4 mg/day.
Clinical Trials Related to Detrol (Tolterodine)
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet [Completed]
To evaluate efficacy of tolterodine extended release formulation compared with immediate
release formulation in subjects with symptoms of overactive bladder
Effects Of Detrol LA On Memory And Cognition In Elderly Population [Completed]
The primary purpose of the trial is to show that tolterodine ER has no effect on memory and
other cognitive abilities in an elderly population
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects [Completed]
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine
on cardiovascular parameters in healthy subjects 50 years of age and older
Detrol LA In Men With Overactive Bladder. [Completed]
An interventional active/placebo double blinded parallel randomized controlled study in which
at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is
measured along with associated safety and other secondary endpoints like bladder diary
endpoints, quality of life and patient treatment satisfaction.
Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and
Urgency of at least 1 episode per day confirmed by bladder diary).
Patients are not eligible to enroll in the study if they have/had significant hepatic or
renal disease, history of radiation treatment.
Detrol (Tolterodine) Post Surgery for Benign Prostatic Hyperplasia [Recruiting]
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and
urgency with or without the inability to hold your urine until you get to the toilet) are
invited to participate in this research study. Overactive bladder is a common sequelae of
long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after
treatment of the obstruction (transurethral resection of the prostate). These patients are
usually started empirically on alpha-blockers or occasionally anticholinergic agents, former
used to treat enlarged prostate medically, and latter, to treat overactive bladder. The
investigators hypothesize that these patients would be significantly improved with a
long-acting anticholinergic agent such as Detrol LA (tolterodine).
Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on
symptoms of patients with bladder outlet obstruction and overactive bladder. In addition,
anticholinergic drug tolterodine is not associated with increased incidence of complication
like acute urinary retention, a state where patient is unable to empty the bladder as an
adverse effect of the drug.
A large proportion of our patients that are undergoing treatment for bladder outlet
obstruction also have overactive bladder. The investigators propose a double blind,
randomized, placebo-controlled trial to evaluate the efficacy of Detrol LA 4mg, an
anticholinergic in patients that have continued symptoms of overactive bladder one month
following transurethral resection of the prostate. Patients with overactive bladder on
urodynamic test preoperatively will be considered. If these patients continue to have
symptoms at the one-month post-operative visit, they will be enrolled into the study. The
investigators expect a total of 50 patients to be enrolled within 4 months. One arm will
receive placebo, the other will receive Detrol LA 4 mg. The patients will be followed at 3
months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients
will fill out an American Urological Association (AUA) symptom score questionnaire, have
noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan.
Using standard statistical analysis, the investigators will see if there is a difference in
symptoms, post-void residual, or maximum flow rate between the two arms at 6 months. The
investigators will continue in an open-label manner after six months. If the Detrol LA arm
has better outcomes, the investigators will offer the placebo group Detrol LA 4mg at the six
month period and continue the study to evaluate long-term efficacy, dropout rate, and
complications. No dosing adjustments will be allowed for the duration of the study.
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