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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

NCT01540786 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-10-15

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

High resolution urodynamic assessment

PROCEDURE

Conventional urodynamic assessment

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Study Manager · Astellas Pharma Europe Ltd.

  • Principal Investigator · Maastricht University Medical Center, Maastricht

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540786 on ClinicalTrials.gov