Overactive Bladder (OAB)
  Ongoing Clinical TrialsTrial Status


Protocol Number: 191622-520  08/2009 - Present


Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Safety Efficacy of a Single Treatment of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX as Applicable in Patients with Idiopathic Overactive Bladder with Urinary Urgency Incontinence.Purpose of Study

To evaluate the efficacy and safety of BOTOX 100 U compared with placebo in patients with idiopathic overactive bladder (OAB) with urinary incontinence whose symptoms have not been adequately managed with anticholinergic therapy.

Trial Status


Protocol Number: UPC121908 STEP 01/2009 - PresentSponsor: Uroplasty

Title: Sustained therapeutic effects of Percutaneous Tibial Nerve Stimulation.

Purpose of Study

We are currently conducting an extension study of the Urgent PC system. The purpose of this study is to observe and evaluate long-term therapy of Urgent PC for the treatment of overactive bladder (OAB) symptoms of urge incontinence, urinary urgency, and urinary frequency.


List of Completed Trials for Overactive Bladder (OAB)

Protocol Number:CL-10-0001 05/2010-02/2011

Sponsor:Johnson & Johnson Internal Ventures

Title: Pilot clinical trial to study the effectiveness of a fourweek exposure to transcutaneous, high frequency, amplitude-modulated, non-invasive neurostimulation device on urgency (urinary) incontinence in subjects with idiopathic overactive bladder (OAB)

Protocol Number: C-2001-019 12/2001-11/2002

Sponsor: Alza Corporation

Title: A comparison study of the efficacy and tolerability of Ditropan XL and Detrol LA in the treatment of overactive bladder in women age 18 and older.

Protocol Number: URO-101 12/2005 - 09/2006

Sponsor: Urigen Holdings Inc.

Title: A phase II multicenter, randomized, double-blind, placebo controlled study to evaluate the safety and efficacy of intravesical alkalinized lidocaine-heparin for the symptoms of pelvic pain and urgency of bladder origin.

Protocol Number: UPC032006 09/2006 - 01/2009

Sponsor: Uroplasty

Title: Overactive bladder innovative therapy trial ORBIT Trial, a randomized study comparing Urgent PC percutaneous tibial nerve stimulation with standardized pharmacologic therapy (Detrol LA) in reducing the frequency of urinary voids.

Protocol Number: A0221009 12/2007 - 05/2009

Sponsor: Pfizer, Inc.

Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fesoterodine as an Add-On Therapy in Men with Persistent Overactive Bladder Symptoms Under Monotherapy of Alpha Blocker for Lower Urinary Tract Symptoms.

Protocol Number: UPC082008 SUmiT 10/2008 - 05/2009

Sponsor: Uroplasty

Title: A prospective, multi-center, randomized, intention-to-treat, double blinded, sham-Controlled study. Subjects are randomized 1:1 at enrollment to receive either Urgent PC or Sham intervention in treatment of Overactive Bladder symptoms.

Clinical Research Coordinators:

Lisa Bennett, RN or Michelle Utrera (336) 274-1114 ext. 5322
E-mail address: research@allianceurology.com

Protocol Number: 905-EC-012                    07/2013 - Present
Title: A Randomized, Double-Blind,  Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 weeks and Warrant Addtitional Relief for their OAB Symptoms.

Purpose of Study
The purpose of this study is to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) will be more effective in controlling incontinence than when using the antimuscarinc treatment alone


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