Main objectives are to identify brain areas involved in sensation of bladder filling through fMRI during urodynamic measurements. Secondary goals are to assess the correlation between bladder filling and subjects* bladder sensations in combination…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During urodynamic assessments we will measure bladder pressure changes during
the filling phase with water pressure urodynamics during the fMRI study.
Secondary outcome
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.
Background summary
Overactive Bladder syndrome (OAB) is a medical condition with symptoms of
urgency, with or without incontinence, usually with frequency and nocturia,
with no proven infection or obvious pathology 1. This study will explore the
relationship between OAB, obstruction and the micro contractions as well as the
brain areas involved in both normal desire to void and urgency, gaining a
better understanding of the bladder pathophysiology and in the future allowing
better strategy of treatment options for patients suffering from OAB.
Study objective
Main objectives are to identify brain areas involved in sensation of bladder
filling through fMRI during urodynamic measurements. 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.
Study design
The study aims to identify differences in bladder flling activities between OAB
subjects and healthy subjects, using urodynamic assessment and study relevant
brain areas involved in urgency sensation using fMRI. Study will be conducted
according to open, non-randomized, parallel group design. The study is set up
as an exploratory study to use FMRI brain imaging to study the relevant brain
areas involved in bladder sensation.
Study burden and risks
Most of the assessments (physical examination, pregnancy test, diary and
questionnaires) are all standard for patients with lower urinary tract symptoms
and do not pose additional risk. After urodynamic investigation subjects may
experience a burning sensation during urination. The risk of developing urinary
tract infection is very low. Regarding the fMRI, certified users will always
stay below the limits for radiofrequency and magnetic resonance, making 7T
scanning harmless. 5% may experience vertigo or nausea while entering the
scanner. Slowing the subject*s entry and exit time into the magnetic field will
minimize these symptoms.
There is no intended direct clinical benefit for the subjects participating in
this study.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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
25. patients with any metal imlants in the body (except dental implants) that
would prevent the patients to undergo fMRI scan.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL52605.068.15 |