Frequency and Urgency Overactive Bladder
Conditions
Interventions
None listed
Sponsors
Astellas Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring and identifying nonvoiding activity with conventional and highresolution urodynamics in female patients suffering OABsc and healthy female volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To identify NVA in healthy and OAB subjects using conventional urodynamic assessment - To assess the subjects bladder sensations measured by visual analogue scale (VAS) and 5-points grading scale (Appendix 7 & 8) during the high resolution urodynamic and conventional assessments - To assess the correlation between NVA and subjects bladder sensations - To explore NVA in a subgroup of subjects defined by the severity of OAB symptoms collected as background information (3-days bladder diary) - To illustrate the amount of NVA detected with high resolution urodynamic test methodology compared to NVA detected with conventional urodynamic assessments - To assess symptoms severity, bother and its impact on quality of life using: OAB-Q short form and Uroginal Distress Inventory (UDI-6) questionnaires and a 3 Day micturition bladder diary as background information to characterize the study population | — |
Countries
Netherlands
Outcome results
None listed