Clinical Trials Resource Center

New Medical Therapies™

Urinary Incontinence

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.

April 2, 2012

Allergan released initial results from two phase III trials evaluating Botox for the treatment of idiopathic overactive bladder (OAB). The trials enrolled subjects with symptoms of OAB not caused by a neurological condition who reported urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. The subjects were randomly assigned to treatment with Botox or placebo injections into the detrusor (bladder) muscle, followed by an injection with Botox after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in the Botox group versus the placebo group (p<0.001). Botox treatments were well tolerated and adverse events were primarily limited to the urinary tract.

March 5, 2012

AltheRx Pharmaceuticals reported results from a phase II trial of Solabegron for the treatment of overactive bladder (OAB). This randomized, double-blind, placebo-controlled, parallel group study enrolled 258 women with moderate to severe OAB symptoms (averaging 4.5 incontinence episodes per day). The subjects received Solabegron (50 mg and 125 mg) or placebo twice daily for eight weeks. The 125 mg dose of Solabegron produced a 65.6% reduction from baseline in incontinence episodes, a statistically significant difference from placebo of 21% (p<0.025). The subjects treated with Solabegron also reported a significant reduction in the frequency of urination (-0.8; p≡0.036), and a marked and significant increase in the volume of urine voided (+27%; p<0.001) both compared to placebo. Solabegron was safe and well-tolerated. Adverse events did not differ between the placebo and active treatment groups; the most common reported adverse events were headache and nasopharyngitis.

December 5, 2011

Provesica reported results from a phase I trial of XEN-D0501 for the treatment of overactive bladder. The trial was conducted in two parts. Part 1 was a double-blind, randomized, placebo-controlled, two-way crossover study in three cohorts of 12 subjects. Each subject received XEN-D0501 (1, 2.5 or 5 mg) or placebo twice daily for 13 days. Part 2 was an open-label, randomized, two-way crossover study in subjects aged 45 to 65 years who received single doses of 5 mg XEN-D0501 under fasted and fed conditions. As some TRPV1 antagonists affect body temperature, one of the objectives was to determine the effect of XEN-D0501 on body temperature. No substantial changes in body temperature were observed at any of the three dose levels administered. XEN-D0501 was safe and well tolerated at doses up to 5 mg twice daily for 14 days.

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.

September 27, 2010

GW Pharmaceuticals reported positive results from a phase II trial of Sativex for the treatment of bladder dysfunction related to multiple sclerosis. This double-blind, randomized, placebo-controlled, parallel-group trial enrolled 135 subjects with multiple sclerosis and overactive bladder that was not responding well to current standard of care. The subjects received Sativex or placebo in addition to standard of care for eight weeks. Sativex resulted in statistically significant improvement in a range of bladder symptoms, including nocturia (p≡0.01), daytime frequency, frequency for 24 hours (p≡0.044) and bladder symptom severity (p≡0.001). A significant effect was also seen in the patients global impression of change (p≡0.005). There was no significant effect on incontinence.

August 2, 2010

Antares Pharma reported positive results from a phase III trial of Anturol Gel for the treatment of overactive bladder. This randomized, double-blind, parallel, placebo controlled, multi-center trial enrolled 600 subjects who received two dose strengths of Anturol (56 mg or 84 mg) administered topically once daily (QD) or placebo for 12 weeks. The primary endpoint was reached: both doses showed a statistically significant reduction in urinary incontinence episodes versus placebo (p≡0.028 and 0.033 respectively). In addition, the 84 mg dose provided highly statistical significant results for the secondary end points of urinary frequency and volume. Anturol was well tolerated and no serious adverse events related to the treatment were reported.

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.

February 27, 2006

Antares Pharma announced positive results of phase II trial of Anturol (oxybutynin topical gel) for the treatment of overactive bladder (OAB). The drug produced dose-proportional, linear pharmacokinetics across all study doses, and the middle dose of the drug produced plasma concentrations of the drug comparable to an approved transdermal patch formulation of oxybutynin. The drug was well tolerated, with 98.3% of patients experiencing no skin irritation (compared to 50% for the transdermal patch formulation), and Anturol gel produced a lower ratio of desethyloxybutynin (an active metabolite of the drug associated with adverse events) to oxybutynin, compared to the transdermal patch. This parallel dose study enrolled 48 healthy volunteers, who received daily topical applications of one of 3 doses of the drug over 20 days. Based on these results, the company announced plans to initiate a phase III trial of the drug in the second half of 2006.

Nymox announced safety results of a phase II trial of NX-1207, for the treatment of benign prostatic hyperplasia (BPH). Results from the ongoing study to date yielded no serious drug-related adverse events. Further, no sexual side effects were observed, and overall side-effect rate and severity may be superior to existing treatments. These data were sufficiently positive for the trials Independent Data Monitoring Committee to recommend continuation of the study, with no modifications to the trial's design. This study is ongoing across multiple study sites; final data will include pivotal safety and efficacy results.

August 9, 2004

Lilly and Boehringer-Ingelheim released additional results of a 12 week extension of their phase III study of Yentreve (duloxetine), a dual serotonin/norepinephrine reuptake inhibitor for the treatment of stress urinary incontinence (SUI) in women. Post-hoc analysis confirmed that the drug was efficacious in relieving SUI symptoms, with a significant improvement in self assessed disease severity at 4 weeks and no significant difference at 12 weeks between subjects switching to duloxetine in the extension from placebo vs. those taking duloxetine the whole time. This open label extension evaluated a total of 493 women with recurrent SUI, all of whom had participated in the initial single-blind, placebo controlled phase III study. Duloxetine, under the trade name Cymbalta, was approved this week for the treatment of major depression.

September 15, 2003

Eli Lilly and Boehringer Ingelheim reported positive results from a phase III trial investigating duloxetine, a duel reuptake inhibitor for the treatment of stress urinary incontinence (SUI). Results showed that treatment with duloxetine significantly reduced the number of weekly incontinence episodes among women. In addition, 51% of all subjects taking duloxetine experienced a 50% to 100% reduction in frequency of incontinence episodes. Data also showed that women on duloxetine experienced significant improvements in quality of life measures, compared with placebo. The double blind placebo-controlled study enrolled 683 women aged 22-84 years old and was conducted in the U.S. and Canada. Subjects had experienced at least seven episodes of incontinence per week. Results were published in September 2003 in the Journal of Urology.

July 29, 2002

Results of a phase II, double blind, randomized, placebo-controlled clinical trial involving 553 adult female subjects indicated that duloxetine reduced the frequency of incontinence episodes in women by 64 to 100%, compared to a median reduction of 41% in the placebo group. A similar reduction was achieved in a subset of subjects with more severe incontinence. Results also showed that 44% of subjects in the duloxetine arm reported significant improvement in quality of life, compared to 27% of those in the placebo arm who gave the same measures of improvement. Duloxetine is being developed by Eli Lilly.

February 19, 2002

Preliminary phase IIIb trial results indicate that treatment with Watson Pharmaceuticals' transdermal oxybutynin significantly reduces incontinent episodes compared to placebo. The multicenter, placebo-controlled, double-blind study evaluated treatment with transdermal oxybutynin twice weekly, Detrol LA (an oral medication) daily or placebo. In the trial, 361 subjects were randomized into three parallel treatment arms and treated for 12 weeks. Daily urinary incontinent episodes decreased by 42% in the placebo group, compared to 62% in the transdermal oxybutynin group and 64% in the Detrol LA group. There was a low incidence of anti-cholinergic side effects, such as dry mouth, with both Detrol LA and transdermal oxybutynin.

February 11, 2002

Results of a pilot study support the efficacy and safety of FemSoft Insert as a treatment for exercise-induced incontinence. Rochester Medical's FemSoft Insert is a single-use liquid and silicone device approved for the treatment of stress urinary incontinence. Study results showed that all subjects experienced less urinary leakage while using the FemSoft Insert during exercise activities. Median urine loss was 20g in women not wearing the device compared to 2.58g for those using the product. Additionally, at the end of three months, satisfaction and comfort received high ratings on surveys completed by study subjects.

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.