Study of brain areas involved in the sensation of bladder filling in healthy females and untreated females with Overactive Bladder (OAB) using fMRI and water pressure urodynamics

Recruiting

• Conditions: Overactive bladder syndrome; 10004994

• Registration Number: NL-OMON55567
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 48

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, 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 <40 or >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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>During urodynamic assessments we will measure bladder pressure changes during<br /><br>the filling phase with water pressure urodynamics during the fMRI study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary goals are to assess the correlation between bladder filling and<br /><br>subjects* bladder sensations in combination with psychological anxiety and<br /><br>depression status, measured through Hospital Anxiety and Depression Score<br /><br>(HADS) questionnaire.</p><br>