Status:
COMPLETED
Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder
Lead Sponsor:
Samsung Medical Center
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Overactive bladder (OAB) is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia" in the absence of local pathological or endocrine factors. Urgency is defined a...
Detailed Description
12-week multi-center, prospective, parallel, double-blind, placebo-controlled trial
Eligibility Criteria
Inclusion
- age ≥ 18 years
- Overactive bladder for at least 3 months
- 3 day- voiding diary
- average urinary frequency ≥ 10 voids/24hrs
- urgency ≥ 2 episodes/24hrs
- "moderate to severe" in the Indevus Urgency Severity Scale (IUSS)
Exclusion
- clinically significant stress urinary incontinence
- polyuria of more than 3000 ml/24 hrs
- severe hepatic or renal diseases
- contraindications to the use of antimuscarinic drugs
- genitourinary conditions that could cause OAB symptoms such as urinary tract infection, genitourinary malignancy or interstitial cystitis
- uninvestigated hematuria
- clinically significant bladder outlet obstruction
- clinically significant pelvic organ prolapse
- being on a bladder-training program or having been on electrostimulation therapy two weeks before randomization or intention to start
- unstable dosages of drugs with anticholinergic side effects
- any other investigational drug taken up to 2 months prior to randomization
- pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00903045
Start Date
January 1 2005
End Date
August 1 2006
Last Update
May 15 2009
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea