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.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Patients:
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
10. Has a positive pre-study hepatitis A, B surface antigen, hepatitis C antibody or HIV result at time of screening.
11. Any use of drugs of abuse within 3 months prior to screening visit.
12. History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit.
13. History of drinking more than 14 units of alcohol per week (1 unit = 10 g pure alcohol = 250 ml of beer (5%) or 35 ml of spirits (35%) or 100 ml of wine (12%) within 3 months prior to screening visit.
14. Is currently receiving or has a history of treatment with alpha blockers, beta receptor blockers or agonists, botulinum toxin (less than 12 months), resiniferatoxin or pelvic floor muscle relaxants less than or equal to 9 months prior to screening.
15. Any clinically significant abnormality following the investigator*s review of the pre-study physical examination and 12 lead ECG

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Measuring and identifying nonvoiding activity with conventional and<br /><br>highresolution urodynamics in female patients suffering OABsc and healthy<br /><br>female volunteers.</p><br>

Secondary Outcome Measures