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A Double blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients with Stress Urinary Incontinence

The study will evaluate the injection of AMDC for Urinary Sphincter Repair (USR) compared to a placebo dose, with the hypothesis that one or two treatments of AMDC is statistically superior to placebo at 12 months following the initial treatment.

A MULTI-CENTER, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, THIRD PARTY OPEN, PLACEBO CONTROLLED, PILOT STUDY TO ASSESS THE URODYNAMIC EFFECTS OF MODIFIED RELEASE UK-369,003 IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS)

A pilot study to:1. assess the urodynamic changes induced by 100mg MR formulationof UK-369,003 vs. placebo in men with LUTS;2. Assess the safety and tolerability of UK-369,003 in men with LUTS

A phase II, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 3236 tablets in men with Lower Urinary Tract Symptoms (LUTS) suggestive of Benign Prostatic Hyperplasia (BPH)

The objectives are to evaluate:- The effect of Org 3236 on prostate volume compared to placebo;- The effect of Org 3236 on LUTS compared to placebo;- The effect of Org 3236 on urinary flow and postvoid residual volume compared toplacebo;- The effect…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

This study is designed to demonstrate the CV and renal effects of sotagliflozin in patients with T2D, high CV risk, and moderate renal impairment. One of the major objectives of this study is to fulfill the regulatory mandate that any new therapy…

A Prospective, Randomized Clinical Trial Evaluating INTIBIA (TM), an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months

The purpose of the INTIBIA pivotal study is to demonstrate the safety and effectiveness of the INTIBIA System in the intended population through 24 months of follow-up. Data at 12-months will be used to support regulatory approval.The objective of…

Double-blind, placebo-controlled phase 1 trial of nizaracianine administered in three divided doses to healthy volunteers

Primary• To assess the safety and tolerability in healthy volunteers of nizaracianine administered IV in three divided dosesSecondary• To perform pharmacokinetic analyses of blood and urine• To determine if bolus injection of nizaracianine enables…

A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP,
PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF
ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF
DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS
WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY
OR MULTIPLE SCLEROSIS

Target Population:Subjects with urinary incontinence (UI) caused by neurogenic detrusor overactivity (NDO)due to either spinal cord injury (SCI) or multiple sclerosis (MS), who have not beenadequately managed with oral medication and who routinely…