An Exploratory Study to Investigate Bladder Contractions in the Storage Phase and Related Bladder Sensations in Healthy Females and Females With Overactive Bladder (OAB) Using High Resolution and Conventional Urodynamics
Last updated on July 2021Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 45
Summary
- Conditions
- Healthy Subjects
- Overactive Bladder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 35 years and 65 years
- Gender
- Only males
Description
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, ques...
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.
Tracking Information
- NCT #
- NCT01540786
- Collaborators
- Not Provided
- Investigators
- Study Chair: Clinical Study Manager Astellas Pharma Europe Ltd. Principal Investigator: Principal Investigator Maastricht University Medical Center, Maastricht
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