You had previously indicated interest in an OAB study with UBC.  We are contacting you to inquire about your interest in another OAB opportunity.
 
This is a Multi-center, double-blind, parallel-group, randomized placebo-controlled, Phase III study of an intravesical study drug given as a single dose in patients with Idiopathic Overactive Bladder.  Post instillation, at 12 weeks, all blinded subjects (active or placebo) will have the option of an additional instillation of study drug.  All subjects will be followed up for 24 weeks after their initial instillation.
Study Population:
Male and non-pregnant, non-lactating non-postpartum (1 year) female OAB patient 18 years of age and older with symptoms of urinary urgency and increased daytime frequency with or without urinary urgency incontinence and nocturia, who have had inadequate response or limiting side effects with oral therapy for the treatment of OAB and who meet all of the inclusion and exclusion criteria.
Inclusion Criteria
1.  Male or female, 18 years or older;
2.  OAB symptoms have been present for 6 or more months;
3.  Subjects with OAB symptoms who have had inadequate response or limiting side effects with oral therapy as defined by lack of response to an oral agent after a minimum duration of treatment for one month for or unable to tolerate at least 2 different oral agents;
4.  Mean daily urinary frequency ³8 micturitions/24h, as recorded in a 72‑hour bladder diary during the two weeks preceding randomization;
5.  At least 2 urgency episodes/24h (with or without incontinence) as recorded in the 72‑hour bladder diary during the two weeks preceding randomization;
6.  Main reason for urine loss is urgency incontinence as defined by a ratio of greater than 2:1 urgency incontinence:non-urgency incontinence episodes as documented in the patient baseline bladder diary;
7.  Patient with nocturia defined as waking from regular sleep to void, on average more than once per night as recorded in the 72‑hour bladder diary during the two weeks preceding randomization;
8.  Patient with at least 1 voided volume ³75 mL in a 24‑hour period, confirmed by the bladder diary during the week preceding randomization;
9.  Patient able and willing to correctly and independently complete the patient bladder diaries for 3 days prior to each visit, and to complete questionnaires during clinic visits;
10.  Females who are of childbearing potential must have had a negative pregnancy test prior to enrollment, and must be using medically accepted contraception or have a monogamous relationship with a partner who has undergone sterilization;
11.  Negative urinalysis at Screening and Baseline; if urinalysis is positive at Screening, patient must have a negative urine culture at Baseline;
Exclusion Criteria
1.  Total daily volume voided >3000 mL, as documented in the patient baseline bladder diary;
2.  Total average volume voided >250 mL per void, as documented in the patient baseline bladder diary;
3.  Nocturia due to renal insufficiency or heart failure
4.  Insensate incontinence, overflow incontinence or urinary fistula;
5.  Subjects with neurological disease that could underlie or contribute to their urinary symptoms;
6.  Subjects with clinical diagnosis of benign prostate hyperplasia (BPH) or bladder outlet obstruction;
7.  Subjects with an indwelling catheter or requiring intermittent catheterization;
8.  Subjects with postvoid urinary residual (PVR) defined as a post-void volume greater than 150 mL as assessed ultrasonographically at Screening or at Randomization;
9.  Subjects with pelvic or pelvic floor surgery performed within the past 6 months;
10.  Subjects who have had surgical mesh for prior pelvic floor surgery;
11.  Subjects with a history of urethral stricture, a urethral diverticulum, or a low compliance bladder;
12.  Males with prostate-specific antigen (PSA) ³4 ng/mL or a significantly rising PSA;
13.  Subjects diagnosed with lower urinary tract malignancy;
14.  Subjects with a history of interstitial cystitis/painful bladder syndrome;
15.  Subjects with vesicoureteral reflux or a history of treatment for vesicoureteral reflux;
16.  Subjects with history of pyelonephritis, stone disease or impaired renal function with elevated serum creatinine over 2.0 mg/dL;
17.  Subjects undergoing or who have undergone treatment with neuromodulation or electro-stimulation for urinary and/or bowel symptoms in the past 6 months;
18.  Subjects who have had an interstim electrode implanted
19.  Subjects with uninvestigated hematuria;
20.  Subjects with acute urinary tract infection (UTI) during the washout period or screening or who have recurrent UTI urinary tract infection or history of recurrent UTIs (2 uncomplicated UTIs in 6 months or 3 positive cultures within the preceding 12 months);
21.  Subjects who have started bladder retraining or pelvic floor rehabilitation programs within the past 3 months or who are not stable on these programs;
22.  Female subjects with a uterovaginal prolapse that protrudes through the introitus at rest or on standing;
23.  Female subjects who are pregnant, gave birth within the last year of who are nursing mothers;
24.  Prior participation in a Botox trial or prior exposure to Botox for urological conditions;
25.  Subjects with a known hypersensitivity to any of the study medications;
26.  Subjects unwilling to discontinue prohibited medication(s);
27.  Subjects with a history or clinical manifestation of significant metabolic, hepatic (defined as 2´ the upper limit of the reference ranges for serum concentrations of aspartate transaminase [AST], alanine transaminase [ALT]), renal, or non-OAB urological disorders;
28.  Prior participation in an trial using an intravesical treatment of a vanilloid
29.  Subjects participating in another clinical trial or who have taken a non-approved drug or received intravesical treatment(s) within the past 3 months;

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* 1. Name/Address

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* 2. Contact Information

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* 3. Are you interested in participating in this study?

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* 4. What is the total number of Idiopathic OAB subjects you estimate you could enroll based upon the Inclusion/exclusion criteria provided in a 1 month period?

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* 5. Of these patients, what percentage are considered as having an Inadequate response to standard therapy?

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* 6. Of these patients, what percentage are Intolerant to current therapies?

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* 7. Do you have equipment/supplies to catheterize/instill patients (e.g. sterile gloves, lubricant, IV pole)?

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* 8. Do you have designated rooms where a patient can have drug administered and remain for the required medication retention period?

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* 9. Have you worked on any past OAB trials using a bladder instilled medication?

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