NCT01540786

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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, 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.

Conditions

• Healthy Subjects
• Overactive Bladder

Interventions

Type	Name	Description
PROCEDURE	High resolution urodynamic assessment
PROCEDURE	Conventional urodynamic assessment

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-02-29
• Last updated: 2014-10-15

Locations

1 site across 1 country: Netherlands