Dinorah Rodriguez

Preliminary results of a dose‐finding study for botulinum toxin‐A in patients with idiopathic overactive bladder: 100 versus 150 units

To evaluate the clinical outcomes of two different doses of BTX‐A in patients with I‐OAB.

Pramipexole in levodopa-treated Parkinson disease patients of African, Asian, and Hispanic heritage

Background: Little is known regarding the effects of antiparkinsonian drugs in US racial or ethnic minorities. Objective: To evaluate the safety, tolerability, and efficacy of adjunctive pramipexole in Parkinson disease (PD) patients of African, Asian, or Hispanic heritage stably treated with levodopa. Design: Multicenter, parallel-group, double-blind, randomized, placebo-controlled trial. Setting: Seventeen Parkinson Study Group sites in the United States and Puerto Rico. Patients: One hundred forty-four PD patients of African, Asian, or Hispanic heritage enrolled from January 1997 to August 1998 and observed until October 1998. Intervention: Subjects received pramipexole or placebo (3:1 ratio), 0.375 mg/d to a maximum tolerated dose (≤4.5 mg/d) over a 6-week period, achieving optimum levels (0.375, 1.5, 3.0, or 4.5 mg/d) in the 4-week maintenance period. Main Outcome Measure: Change in the sum of the Unified Parkinsons Disease Rating Scale parts 2 (activities of daily living) and 3 (motor) from baseline to week 10. Results: Parkinsonism improved (mean [SD] reduction in Unified Parkinsons Disease Rating Scale activities of daily living + motor score at 10 weeks, 10.27 [11.96] pramipexole vs 6.54 [13.58] placebo, P = 0.012) and was similar in each group. Adverse events occurred in 85.3% on pramipexole and 68.6% on placebo. Hallucinations and insomnia were more common on pramipexole than placebo (18 vs 0, P = 0.023, and 15 vs 0, P = 0.045, respectively). Conclusions: Pramipexole is an effective adjunctive antiparkinsonian therapy in PD patients of African, Asian, and Hispanic heritage. Tolerability and safety overall were similar among the groups, but differences in profiles of adverse effects and tolerability were suggested.

Building a clinical research network in trauma orthopaedics: The major extremity trauma research consortium (METRC)

Objectives: Lessons learned from battle have been fundamental to advancing the care of injuries that occur in civilian life. Equally important is the need to further refine these advances in civilian practice, so they are available during future conflicts. The Major Extremity Trauma Research Consortium (METRC) was established to address these needs. Methods: METRC is a network of 22 core level I civilian trauma centers and 4 core military treatment centers—with the ability to expand patient recruitment to more than 30 additional satellite trauma centers for the purpose of conducting multicenter research studies relevant to the treatment and outcomes of orthopaedic trauma sustained in the military. Early measures of success of the Consortium pertain to building of an infrastructure to support the network, managing the regulatory process, and enrolling and following patients in multiple studies. Results: METRC has been successful in maintaining the engagement of several leading, high volume, level I trauma centers that form the core of METRC; together they operatively manage 15,432 major fractures annually. METRC is currently funded to conduct 18 prospective studies that address 6 priority areas. The design and implementation of these studies are managed through a single coordinating center. As of December 1, 2015, a total of 4560 participants have been enrolled. Conclusions: Success of METRC to date confirms the potential for civilian and military trauma centers to collaborate on critical research issues and leverage the strength that comes from engaging patients and providers from across multiple centers.

THE NEED FOR INTERMITTENT CATHETERIZATION DURING REPEATED BOTOX® INJECTIONS FOR IDIOPATHIC OAB

Hypothesis / aims of study In this prospective, IRB approved, randomized, ongoing study we evaluated the efficacy of intra-detrusor injection of BOTOX ® botulinum A toxin (BTX) in patients (pts) with idiopathic overactive bladder (IOAB) resistant to antimuscarinic therapy. The aim of this study was to evaluate the post-void residual volume (PVR) throughout the study and to assess how many patients will need self intermittent catheterization (CIC).