Overactive bladder syndrome
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy Subjects 1. Healthy female subjects aged 18 or older 2. Has provided written informed consent prior to any study related procedures., OAB Subjects 1. Female subjects aged 18 or older 2. Has provided written informed consent prior to any study related procedures. 3. History of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months. 4. At enrolment visit (V2) the subjects must have: - 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 5. At the screening visit, the subject should be either naïve to OAB treatment (e.g no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks.
Exclusion criteria
Exclusion criteria: Exclusion Criteria, 1. History of lower urinary tract symptoms (LUTS), including OAB (healthy subjects) 2. History of stress urinary incontinence, urethral sphincter incompetence and neurogenic detrusor overactivity . 3. History of signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis). 4. History of bladder outlet obstruction (not including detrusor-overactivity) for example bladder/vesicouterine pro-lapse (> grade II) or chronic obstruction. 5. History of urinary tract surgery less than or equal to 6 months prior to screening. 6. Has an indwelling catheter or permanent catheter fitted. 7. History of pelvic area radiotherapy treatment. 8. Uncontrolled diabetes mellitus. 9. History of fibromyalgia. 10. 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 and vasectomized partner). 11. Pregnancy within 6 months before screening or breast feeding within 3 months before screening. 12. History of positive hepatitis A, B surface antigen, hepatitis C antibody or HIV test result. 13. Any use of drugs of abuse within 3 months prior to screening visit. 14. History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit. 15. 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. 16. Has any changes to prescribed medication or to dose of prescribed medication less than or equal to 1 month prior to screening which in the opinion of the Investigator, will interfere with the study procedures or compromise safety. 17. 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. 18. Any clinically significant abnormality following the investigator*s review of screening physical examination. 19. Any clinically significant history of any other disease or disorder- gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator. 20. Abnormal pulse and/or blood pressure measurements at the screening visit as follows: Pulse 90 bpm; systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg; blood pressure and pulse measurements after subject has rested for 10 minutes. 21. Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life. 22. Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the study. 23. Employees of the MUMC University of Maastricht involved in the study. 24. Claustrofobia, preventing a patient to have an fMRI scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During urodynamic assessments we will measure bladder pressure changes during the filling phase with water pressure urodynamics during the fMRI study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary goals are to assess the correlation between bladder filling and subjects* bladder sensations in combination with psychological anxiety and depression status, measured through Hospital Anxiety and Depression Score (HADS) questionnaire. | — |
Countries
Netherlands
Outcome results
None listed