Basic Sensations Coming From the Bladder

Healthy Clinical Trial

Official title:

Description of Basic Visceral Sensations Coming From the Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114412
• Other study ID #: 09-4-045.8
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Healthy
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

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