Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

• Status: Withdrawn
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UroGen Pharma Ltd.
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Main Inclusion Criteria:

• Female patient 18 to 75 years old diagnosed with idiopathic OAB.

• Patient has symptoms of OAB for ≥ 3 months prior to screening.

• Patient is a non-responder to pharmacologic therapy or has intolerable side effects or is not compliant to the treatment.

• On screening three-day voiding diary- Patient has a frequency of at least 8 micturitions per 24 hours & Total of ≥3 urgency urinary incontinence (UUI) episodes.

• Patient is willing and able to initiate self catheterization post-treatment, if required.

• Patients has PVR ≤100 ml. Patient with a single PVR of >100 ml and followed by two consecutive PVR measurements of <100 ml may be included in the study).

Main Exclusion Criteria:

• Patient currently uses CIC or indwelling catheter to manage their urinary incontinence

• Patient who has clinically significant Bladder Outlet Obstruction (BOO).

• Patient with active urinary tract infection.

• OAB due to any known neurological reason.

• Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening visit.

• Predominance of stress incontinence in the opinion of the investigator, determined by patient history.

• Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening.

• Patient with prior botulinum toxin therapy of any serotype within 12 weeks for any indication.

• Patient with prior use of Botulinum toxin therapy of any serotype for any urological condition.

• Patient with previous pelvic radiation therapy.

• Patient had been treated for two or more UTIs within last 6 months or use of prophylactic antibiotics to prevent chronic UTIs.

• ANY condition identified which may cause overactive bladder symptoms