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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01114412
Other study ID # 09-4-045.8
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2009
Est. completion date April 2010

Study information

Verified date April 2010
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Netherlands Maastricht University Medical Centre Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary description of bladder sensations The primary objective of this experiment is to address how medical students and patients with OAB describe the sensations they feel during the filling phase of the bladder.
Primary objectives
To put into simple terms a description of basic visceral sensations coming from the bladder
Describe the pattern of normal sensations during filling
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