Healthy Subjects Clinical Trial
Official title:
An Exploratory Study to Evaluate Bladder Contractions in the Storage Phase (Non Voiding Activities) and Related Bladder Sensation in Healthy Females and Untreated Females With Overactive Bladder ("OAB") Using High Resolution and Conventional Urodynamics
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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