Basic Sensations Coming From the Bladder

NCT ID: NCT01114412

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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A major complication in studies to identify the nature of bladder sensations is language. It is difficult, if not near impossible, for the lay person, with no knowledge of physiology, anatomy or pathology, to put into simple terms a description of basic visceral sensations. Therefore, before the investigators can speculate about the detailed mechanisms generating sensation the investigators must overcome this language and communication difficulty. This will be addressed in the present study.

There are important reasons why the investigators must identify the mechanisms generating the different sensations as the bladder fills. One of them is that these are basic physiological mechanisms which need to be better understood.

Detailed Description

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Conditions

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Healthy Overactive Bladder Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with overactive bladder syndrome

No interventions assigned to this group

Healthy volunteers

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Healthy volunteers

* Healthy students from The University of Maastricht well versed in Dutch.

Patients

* Patients with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days. Before the start of any anticholinergic or other therapy. Patients on anticholinergic therapy will be asked to stop this therapy for at least 10 days before they enter the first session.
* Well versed in Dutch.

Exclusion Criteria

Healthy volunteers

* Use of any medication (except oral contraceptives)
* Surgical history of the abdomen
* Urinary complaints (e.g. frequency, urgency)
* Urinary tract infection

Patients:

* Congestive heart disease or history of heart failure
* Presence of urinary tract infection. These patients will be treated by antibiotics.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gommert A van Koeveringe, MD, PhD, Urologist

Role: STUDY_DIRECTOR

Maastricht University Medical Centre

Locations

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Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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09-4-045.8

Identifier Type: -

Identifier Source: org_study_id

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