Clinical Trials Resource Center

New Medical Therapies™

Bladder Disorders

Patient Medical Areas

April 1, 2013

TheraVida reported results from a phase II trial of Tolenix (THVD-201), for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI). This randomized, double-blinded, multiple-crossover study enrolled 138 patients with OAB or UUI. Subjects received either Tolenix (2mg tolterodine plus 9mg pilocarpine) twice daily, Detrol (tolterodine), or placebo. Patients receiving Tolenix experienced statistically significant improvements in their OAB and UUI symptoms over placebo, with a reduction in daily micturitions of 0.88 (p<0.0001) and a reduction in daily incontinence episodes of 0.47 (p<0.0001). This efficacy was similar in magnitude to the maximum dose of active control Detrol. Patients receiving Tolenix also demonstrated statistically significant and clinically meaningful improvements in their saliva production and dry mouth side effects. In addition, patients noted a statistically significant (p=0.006) improvement in their quality of sleep with Tolenix, relative to Detrol, when assessed by a 100mm visual analog scale. Tolenix was well tolerated. Based on these data, TheraVida plans to conduct additional international studies of Tolenix in OAB and UUI.

January 14, 2013

TheraVida released results from a phase II trial of Tolenix (THVD-201) for the treatment of overactive bladder (OAB)and urge urinary incontinence (UUI). This randomized, double-blinded, multiple-crossover study enrolled 138 patients with OAB or UUI. Subjects received Tolenix (2mg tolterodine plus 9mg pilocarpine) twice daily, or active control Detrol (2mg tolterodine) twice daily or placebo. Results showed subjects treated with Tolenix experienced statistically significant improvements in their OAB and UUI symptoms over placebo control, as well as efficacy similar in magnitude to the maximum dose of active control Detrol. The Tolenix arm demonstrated statistically significant and clinically meaningful improvements in saliva production and dry mouth side effects, as compared to active control Detrol. Tolenix was well tolerated. TheraVida intends to conduct additional international clinical trials.

August 13, 2012

Pfizer issued results from a phase IV comparative trial of Toviaz (fesoterodine fumarate) and Detrol LA for the treatment of overactive bladder (OAB). This parallel-group, placebo-controlled, double-blind study enrolled 642 patients who had been taking Detrol LA 4mg for two weeks and had less than 50% reduction in urge urinary incontinence episodes. After open-label treatment with Detrol LA 4mg, subjects received Toviaz 4mg for one week, followed by Toviaz 8mg for 11 weeks. Data demonstrated that the Toviaz regimen statistically significantly reduced the average number of urge urinary incontinence episodes (-2.37 episodes from baseline) per 24 hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA 4mg. Toviaz was well tolerated. The most frequent adverse events were dry mouth and constipation. Pfizer will conduct further analysis on the study and publish comprehensive results at a later date.

March 28, 2011

Astellas issued results from two phase III trials of mirabegron for the treatment of overactive bladder. One trial was conducted in Europe and Australia and the other trial was conducted in North America. After 12 weeks treatment with once daily mirabegron, significant improvements from baseline were seen in the co-primary endpoints, incontinence episodes and micturitions over 24 hours, compared with placebo (p<0.05). Significant improvements were also recorded in the key secondary endpoints, incontinence episodes and micturitions over 24 hours at week four of treatment (p<0.05 versus placebo), and volume of urine voided/micturition at the final visit (p<0.05 versus placebo). In both studies, mirabegron was well tolerated with low levels of adverse events.

January 14, 2008

Watson reported positive results from a phase III trial of oxybutynin topical gel for the treatment of overactive bladder (OAB). This double blind, placebo-controlled study enrolled 789 subjects with OAB. The primary objective of the study was reached. Daily treatment of a 1g dose (approximately 1 mL) of oxybutynin topical gel for 12 weeks was superior to placebo for the relief of OAB symptoms. Secondary endpoints were reached as well, including a reduction in incontinence episodes and urinary frequency, and an increase in void volume. Treatment was well tolerated, with no serious adverse events reported. Based on the results, Watson plans to file with the FDA for regulatory approval in the second quarter of 2008.

May 21, 2007

Allergan released positive results from a phase III trial of botulinum toxin type A (BTX-A) for the treatment of idiopathic detrusor overactivity in subjects with overactive bladder (OAB). This randomized, double-blind, placebo-controlled trial enrolled 34 subjects who had failed a trial of anticholinergic therapy for six weeks or more. Subjects received a BTX-A or placebo injection and were observed at week 4 and 12 post-treatment. The trial was then un-blinded and the subjects receiving BTX-A were followed up to 24 weeks post-injection. The primary efficacy endpoint was change in maximum cystometric capacity (MCC). Secondary endpoints included changes in OAB symptoms, other measures related to urinary bladder filling and pressure, symptoms of urgency and incontinence, and quality of life. Treatment with BTX-A significantly increased MCC versus baseline at 4 weeks (by about 72%) and 12 weeks (by about 45%), compared to a 15% decrease with placebo at both time points (p<0.0001 and p<0.0011, respectively). BTX-A also significantly improved all secondary endpoints at weeks 4 and 12 compared to baseline, with significantly greater improvements than placebo versus baseline. The 24-week extension study revealed that this benefit was maintained in 36% of the subjects. Based on the results, Allergan plans to move toward the FDA approval of BTX-A for this indication.

May 5, 2003

Yamanouchi Pharmaceutical reported positive results from three phase III trials investigating solifenacin succinate, a muscarinic antagonist for the treatment of overactive bladder (OAB). European results showed that the number of urinations over a 24-hour period decreased as much as 2.82 with solifenacin succinate compared with a reduction of 1.54 urinations with placebo. The U.S. studies found 2.7 fewer urinations over a 24-hour period in the treated group compared to a reduction of 1.4 urinations with placebo. The study enrolled 2,100 subjects at 150 medical centers throughout the U.S. and Europe. The most frequent side effects seen in these clinical trials were dry mouth and constipation.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.