NL-OMON37950
Recruiting
Not Applicable
An exploratory study to evaluate bladder contractions in the storage phase (non voiding activities) and related bladder sensation in healthy females and untreated females with Overactive Bladder (OAB) using high resolution and conventional urodynamics. - Exploratory urodynamic study to bladdercontractions in storage phase
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frequency and Urgency
- Sponsor
- Astellas Pharma
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female subjects aged between 35 and 65 years
- •has signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months defined as:
- •\- At least 1 episode of urgency with or without incontinence in the last 3\-day micturition diary.
- •\- Frequency of micturition greater than or equal to 8 per 24 hours period during the 3\-day micturition diary period
- •Written informed consent
- •Healthy volunteers:
- •Healthy female subjects aged between 35 and 65 years .
- •Written informed consent
Exclusion Criteria
- •Exclusion criteria patients and healthy volunteers:
- •1\. History of stress urinary incontinence, urethral sphincter incompetence, neurogenic detrusor overactivity and overactive bladder.
- •2\. History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), bladder outlet obstruction (not including detrusor\-overactivity) for example bladder/vesicouterine pro\-lapse (\> grade II) or chronic obstruction.
- •3\. History of urinary tract surgery less than or equal to 6 months prior to screening.
- •4\. Has an indwelling catheter or permanent catheter fitted.
- •5\. History of pelvic area radiotherapy treatment.
- •6\. Uncontrolled diabetes mellitus.
- •7\. History of fibromyalgia.
- •8\. Pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants, injectable contraceptives, sexual abstinence or vasectomized partner).
- •9\. Pregnancy within 6 months before screening or breast feeding within 3 months before screening
Outcomes
Primary Outcomes
Not specified
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