This study aims to identify differences in bladder contractions during the storage phase (non voiding activities) between OAB subjects and healthy subjects, using high resolution urodynamics. The study is divided into two parts: * PART 1: Consists of 5 females with overactive bladder * PART 2: Consists of 25 females with overactive bladder and 15 healthy females Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects will be reviewed and analysed by a group of experts before starting the second part (part 2) of the study.
The subjects will complete a total of 2 visits and a follow up telephone call (or visit at the investigator's discretion). Upon meeting eligibility criteria subjects will be screened and complete visit at hospital (Visit 1). They will then be asked to complete procedures such micturition diary, questionnaires and if applicable discontinued their ongoing OAB medication. Upon confirmation of eligibility criteria subjects will then be enrolled and complete visit 2 within 6 to 31 days post V1. At Visit 2 subjects will complete high resolution urodynamic assessment followed by the conventional urodynamic assessment. The visit will take approximately half a day. Safety follow up phone call (or visit at investigator's discretion) will take place 4 to 6 days post visit 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
6
Maastricht University Medical Center
Maastricht, Netherlands
Identify objective parameters to characterize Non Voiding Activity (NVA) in healthy and OAB subjects using high resolution urodynamic assessment
NVA is defined as 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.
Time frame: During the High resolution urodynamics (Day 1)
Identify NVA in healthy and OAB subjects using conventional urodynamic assessment
Time frame: During High resolution and conventional urodynamic (Day 1) assessments
Assess the subjects bladder sensations measured by visual analogue scale (VAS) and 5-points categorical scale (Appendix 8 & 7) during the high resolution urodynamic and conventional assessments
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Assess the correlation between NVA and subjects bladder sensations
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Explore NVA in a subgroup of subjects defined by the severity of OAB symptoms collected as background information (3-days bladder diary)
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Illustrate the amount of NVA detected with high resolution urodynamic test methodology compared to NVA detected with conventional urodynamic assessments
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
Assess symptoms severity, bother and its impact on quality of life using: OAB-Q short form and Urogenital Distress Inventory (UDI-6) questionnaires and a 3-Day micturition bladder diary as background information to characterize the study population
Time frame: During High resolution and conventional urodynamic assessments (Day 1)
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