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Trial Status
OPEN TO ENROLLMENT
Protocol Number: CI-10-0001 05/2010 - Present
Sponsor: Johnson & Johnson Internal Ventures
Title: Pilot clinical trial to study the effectiveness of a four-week exposure to a transcutaneous, highfrequency, amplitude-modulated, non-invasive neurostimulation device on urgency (urinary) incontinence in subjects with idiopathic overactive bladder (OAB)
Purpose of Study
To evaluate the effectiveness by analyzing the change in mean urgency (urinary) incontinence episodes (leaks) between baseline and Week 4 of active treatment.
For further information click here
Ongoing Clinical Trials
Trial Status
CLOSED TO ENROLLMENT
Protocol Number: 191622-520 08/2009 - Present
Sponsor: Allergan
Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel‑Group Study of the Safety and 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.
For further information click here
Trial Status
CLOSED TO ENROLLMENT
Protocol Number: UPC121908 STEP 01/2009 - Present
Sponsor: 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: 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:
Patricia Edwards, RN (336) 274-1114 ext. 5322
Karen Michael, RN (336) 274-1114 ext. 5328
E-mail address: research@allianceurology.com
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