To identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessmentNVA are changes of pressure in the bladder lumen. These changes are measured as detrusor pressure (…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measuring and identifying nonvoiding activity with conventional and
highresolution urodynamics in female patients suffering OABsc and healthy
female volunteers.
Secondary outcome
- 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
Background summary
The International Continence Society (ICS) has defined Overactive Bladder
syndrome (OAB) as a medical condition with symptoms of urgency, with or without
incontinence, usually with frequency and nocturia, with no proven infection of
obvious pathology.
Conventional urodynamic remains the gold standard for investigating lower
urinary tract dysfunction.
High gain high resolution ambulatory urodynamics was developed using pilot data
collected by Gillespie in collaboration with Kulseng Hanssen (unpublished
data). Pilot experiments to test the technical capabilities have been performed
using the Programming Ambulant System Acquition (Pasaq), a ISO 601 certified
and developed by Instrument Development Engineering Evaluation (IDEE)
department of the Maastricht University and approved by the hospital technical
department. The PASAQ system will be used in combination with the unisensor
microtip catheters that have been proven to be functional in regular ambulatory
urodynamic measurements.
This will provide a higher sensitivity of the resolution than conventional
urodynamic in term of frequency and amplitude of signals detected will enable
the capture of bladder micro contractions activity or named throughout the
protocol non voiding activity (NVA).
Study objective
To identify objective parameters to characterize Non Voiding Activity (NVA) in
healthy and OAB subjects using high resolution urodynamic assessment
NVA are changes of pressure in the bladder lumen. These changes are measured as
detrusor pressure (Pdet) calculated from substraction of intra-abdominal
pressure (Pabd) from intra-vesical pressure (Pves). All Pdet with an amplitude
of at least 1cm of water, frequency below 0.2 Hz and pulse duration between 5
and 60 seconds qualify as NVA.
Study design
This is a single site, exploratory study
Intervention
not applicable
Study burden and risks
Patients and healthy volunteers have to visit the function room of the urology
department twice and they will be contacted by telephone at least once after
these visits. At home (between visit 1 en 2) participants have to fill out
questionnaires. At visit 2 participants will ondergo urodynamic inverstigation
both conventional en highresolution urodynamics.
just like all people who undergo a urodynamic investigation the participants
will be explored to a risk of devaloping a urinary tract infection and
short-term hematuria. For both risk factors they will be able to consult the
urology department.
Lovett House
Middlesex, TW18 3AZ
GB
Lovett House
Middlesex, TW18 3AZ
GB
Listed location countries
Age
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
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 |
|---|---|
| Other | ClinicalTrials.gov |
| CCMO | NL36150.068.11 |